<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02990806</url>
  </required_header>
  <id_info>
    <org_study_id>NI071F2</org_study_id>
    <nct_id>NCT02990806</nct_id>
  </id_info>
  <brief_title>A Phase 3 Study of NI-071 in Participants With Rheumatoid Arthritis (RADIANCE)</brief_title>
  <official_title>A Randomized, Double-Blind, Multicenter, 3 Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients With Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nichi-Iko Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nichi-Iko Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to demonstrate similarity of NI-071 (proposed biosimilar to&#xD;
      infliximab) to US REMICADE® (reference product) in terms of safety and efficacy in&#xD;
      participants with rheumatoid arthritis (RA) not adequately responding to methotrexate (MTX).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2017</start_date>
  <completion_date type="Actual">May 20, 2019</completion_date>
  <primary_completion_date type="Actual">May 20, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR20-CRP) Response Rate at Week 22</measure>
    <time_frame>At Week 22</time_frame>
    <description>ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity visual analog scale (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS) (0= no symptoms;100=severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) Health Assessment Questionnaire-Disability Index (HAQ-DI), total score ranging from 0-3 with lower scores meaning less disability, e) CRP.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stage 2 and 3: Area Under the Serum Concentration-time Curve Interval (AUCtau) of NI-071 and Remicade US</measure>
    <time_frame>Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose</time_frame>
    <description>AUCtau of NI-071 and Remicade US in stage 2 and 3 was reported. As this was an interchangeability study, the NI-071 and Remicade only were the comparators and then switch study showed same measurement in relationship to the non-switched participants. Hence, combined data was assessed and collected in participants from Remicade US to Switch Group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stage 2 and 3: Maximum Observed Serum Concentration (Cmax) of NI-071 and Remicade US</measure>
    <time_frame>Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose</time_frame>
    <description>Cmax of NI-071 and Remicade US was reported. As this was an interchangeability study, the NI-071 and Remicade only were the comparators and then switch study showed same measurement in relationship to the non-switched participants. Hence, combined data was assessed and collected in participants from Remicade US to Switch Group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22</measure>
    <time_frame>Baseline, Weeks 2, 6, 14, 18, and 22</time_frame>
    <description>The DAS28-CRP was a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints [assessed on 2-point scale (0=absent; 1=present]), swollen joint count (out of 28 evaluated joints[assessed on 2-point scale (0=absent; 1=present)]), Participant's global assessment of disease activity (assessed on 0-100 mm VAS; where higher scores denotes severe symptoms), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Total Scores on the DAS28-CRP range from 0 to approximately 10 (0=very good, no symptoms; 10=very poor, severe symptoms), where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</measure>
    <time_frame>Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
    <description>The DAS28-CRP was a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints [assessed on 2-point scale (0=absent; 1=present]), swollen joint count (out of 28 evaluated joints[assessed on 2-point scale (0=absent; 1=present)]), Participant's global assessment of disease activity (assessed on 0-100 mm VAS; where higher scores denotes severe symptoms), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Total Scores on the DAS28-CRP range from 0 to approximately 10 (0=very good, no symptoms; 10=very poor, severe symptoms), where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22</measure>
    <time_frame>Baseline, Weeks 2, 6, 14, 18, and 22</time_frame>
    <description>DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (millimeters per hour) and GH recorded on 100mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). DAS28 (ESR) was calculated as 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.70*ln(ESR [mm/hour] + 0.014*GH [mm]; where, TJC28 = number of painful joints out of 28 joints, SJC28 = number of swollen joints out of 28 joints, GH = score of the participant global assessment of disease activity, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. A negative change from baseline indicates improvement in disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</measure>
    <time_frame>Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
    <description>DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (millimeters per hour) and Patient Global Assessment (PtGA) recorded on 100mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). DAS28 (ESR) was calculated as 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.70*ln(ESR [mm/hour] + 0.014*GH [mm]; where, TJC28 = number of painful joints out of 28 joints, SJC28 = number of swollen joints out of 28 joints, GH = score of the participant global assessment of disease activity, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. A negative change from baseline indicates improvement in disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate</measure>
    <time_frame>At Weeks 2, 6, 14, 18, and 22</time_frame>
    <description>ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) CRP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate</measure>
    <time_frame>At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
    <description>ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) CRP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Percentage of Participants Who Achieved Greater Than or Equal to (&gt;=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)</measure>
    <time_frame>At Weeks 2, 6, 14, 18, and 22</time_frame>
    <description>ACR20-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) erythrocyte sedimentation rate (ESR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (&gt;=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)</measure>
    <time_frame>At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
    <description>ACR20-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) (ESR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Percentage of Participants Who Achieved &gt;=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate</measure>
    <time_frame>At Weeks 2, 6, 14, 18, and 22</time_frame>
    <description>ACR50 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2 and 3: Percentage of Participants Who Achieved &gt;=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate</measure>
    <time_frame>At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
    <description>ACR50 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Percentage of Participants Who Achieved &gt;=50% American College of Rheumatology (ACR50) Response Using ESR</measure>
    <time_frame>At Weeks 2, 6, 14, 18, and 22</time_frame>
    <description>ACR50-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2 and Stage 3: Percentage of Participants Who Achieved &gt;=50% American College of Rheumatology (ACR50) Response Using ESR</measure>
    <time_frame>At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
    <description>ACR50-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Percentage of Participants Who Achieved &gt;=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate</measure>
    <time_frame>At Weeks 2, 6, 14, 18, and 22</time_frame>
    <description>ACR70 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2 and 3: Percentage of Participants Who Achieved &gt;=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate</measure>
    <time_frame>At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
    <description>ACR70 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Percentage of Participants Who Achieved &gt;=70% American College of Rheumatology (ACR70) Response Using ESR</measure>
    <time_frame>At Weeks 2, 6, 14, 18, 22</time_frame>
    <description>ACR70-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2 and 3: Percentage of Participants Who Achieved &gt;=70% American College of Rheumatology (ACR70) Response Using ESR</measure>
    <time_frame>At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
    <description>ACR70-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22</measure>
    <time_frame>Baseline, Weeks 2, 6, 14, 18, and 22</time_frame>
    <description>The HAQ-DI score was defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled), where lower scores indicated less disability. Negative change from baseline indicates improvement (less disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</measure>
    <time_frame>Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
    <description>The HAQ-DI score was defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled), where lower scores indicated less disability. Negative change from baseline indicates improvement (less disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22</measure>
    <time_frame>Baseline, Weeks 2, 6, 14, 18, and 22</time_frame>
    <description>Disease activity was assessed using RAPID3, based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain, and participant global estimate.Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give total score=0-10, higher scores=greater difficulty.Pain and global estimate of health measured on Likert scale from '0'=no pain to '10'=pain as bad as it could be. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Total score range of RAPID3 score was 0=no difficulty; 30=greater difficultly, and disease activity categories were as follows: remission: 0-3, low: &gt;3.1 to 6, moderate: &gt;6.1-12, and high: &gt;12.1. Negative change from baseline indicates less disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</measure>
    <time_frame>Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
    <description>Disease activity was assessed using RAPID3, based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain and participant global estimate. Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give total score=0-10, higher scores=greater difficulty. Pain and global estimate of health measured on Likert scale from '0'=no pain to '10'=pain as bad as it could be. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Total score range of RAPID3 score was 0=no difficulty-30=greater difficultly, and disease activity categories were as follows: remission: 0-3, low: &gt;3.1 to 6, moderate: &gt;6.1-12, and high: &gt;12.1. Negative change from baseline indicates less disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 14 and 22</measure>
    <time_frame>Baseline, Weeks 14 and 22</time_frame>
    <description>SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental heallth) with a Subscale Total score for each scaled from 0 (minimum) to 100 (maximum) with a Total Overall score on a 0-800 scale, with higher scores indicating better health. where higher score indicates highest level of functioning. These 8 aspects can also be summarized as Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. Change from baseline in overall total score for SF-36 was reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 38 and 62</measure>
    <time_frame>Baseline, Weeks 38 and 62</time_frame>
    <description>SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental heallth) with a Subscale Total score for each scaled from 0 (minimum) to 100 (maximum) with a Total Overall score on a 0-800 scale, with higher scores indicating better health. where higher score indicates highest level of functioning. Total score for each subscale scaled from 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 8 aspects can also be summarized as PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22</measure>
    <time_frame>Baseline, Weeks 14 and 22</time_frame>
    <description>SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. A Subscale Total score for each scaled from 0 (minimum) to 100 (maximum). Total score for each subscale scaled from 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 2 subscale aspects can also be summarized as PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62</measure>
    <time_frame>Baseline, Weeks 38 and 62</time_frame>
    <description>SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. A Subscale Total score for each scaled from 0 (minimum) to 100 (maximum). Total score for each subscale scaled from 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 2 subscale aspects can also be summarized as PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2 and 3: Minimum Observed Serum Concentration (Cmin) of NI-071 and Remicade US</measure>
    <time_frame>Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose</time_frame>
    <description>Drug concentrations in blood were evaluated from week 46 to week 54 after the initial administration date.&#xD;
Blood sampling was performed before administration of week 46, at the end of the infusion, and at 4 hours, 24 hours, 7 days (week 47), 14 days (week 48), 28 days (week 50), and 56 days (before administration of week 54). Cmin was define as the lowest drug concentration among all blood sampling points for an individual patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2 and 3: Time to Reach the Maximum Serum Concentration (Tmax) of NI-071 and Remicade US</measure>
    <time_frame>Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs</measure>
    <time_frame>Baseline up to Week 62</time_frame>
    <description>An adverse event (AE) was defined as any untoward medical condition that occurs in participants while participating in a clinical study and does not necessarily have a causal relationship with the use of the study treatment. A TEAE was defined as an adverse event with a start date on or after the first dose of Investigational product (IP), or a start date before the date of the first dose of IP but increased in severity on or after the date of the first dose of IP. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Number of participants with TEAEs and Serious TEAEs were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With TEAEs of Special Interest</measure>
    <time_frame>Baseline up to Week 62</time_frame>
    <description>A TEAE was defined as an adverse event with a start date on or after the first dose of IP or a start date before the date of the first dose of IP but increased in severity on or after the date of the first dose of IP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)</measure>
    <time_frame>Baseline, Weeks 2, 6, 14, and 22</time_frame>
    <description>Number of Participants With Positive Serum ADA are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)</measure>
    <time_frame>At Weeks 30, 38, 46, 54, and 62</time_frame>
    <description>Number of Participants With Positive Serum Anti-drug Antibodies (ADA) are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Number of Participants With Positive Serum Neutralizing Antibodies</measure>
    <time_frame>Baseline, Weeks 2, 6, 14, and 22</time_frame>
    <description>Number of Participants with Positive Serum neutralizing Antibodies were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies</measure>
    <time_frame>At Weeks 30, 38, 46, 54, and 62</time_frame>
    <description>Number of Participants with Positive Serum neutralizing Antibodies were reported.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">683</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Stages 1, 2 and 3: NI-071 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received intravenous (IV) infusion of NI-071 at a dose of 3 milligrams/kilograms (mg/kg) at Weeks 0, 2, 6, 14 during stage 1 and at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 1: Remicade-US Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2 and Stage 3: Remicade US to Remicade-US Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2 and Stage 3: Remicade US to Switch Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NI-071</intervention_name>
    <description>IV infusion.</description>
    <arm_group_label>Stage 2 and Stage 3: Remicade US to Switch Group</arm_group_label>
    <arm_group_label>Stages 1, 2 and 3: NI-071 Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remicade</intervention_name>
    <description>IV infusion.</description>
    <arm_group_label>Stage 1: Remicade-US Group</arm_group_label>
    <arm_group_label>Stage 2 and Stage 3: Remicade US to Remicade-US Group</arm_group_label>
    <arm_group_label>Stage 2 and Stage 3: Remicade US to Switch Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a diagnosis of rheumatoid arthritis (RA) as defined by the 2010 American&#xD;
             College of Rheumatology (ACR) and European League Against Rheumatism (EULAR)&#xD;
             classification criteria.&#xD;
&#xD;
          -  Patients have active RA, as confirmed by the following criteria:&#xD;
&#xD;
               -  ≥6 swollen joints and ≥6 tender joints at screening and baseline (28-joint&#xD;
                  count).&#xD;
&#xD;
               -  Either C-reactive protein (CRP) ≥0.7 mg/dL (≥7.0 mg/L) or erythrocyte&#xD;
                  sedimentation rate (ESR) ≥28 mm/h at screening.&#xD;
&#xD;
          -  Patients taking methotrexate (MTX) (oral or parenteral) for at least 3 months prior to&#xD;
             screening and at a stable dose of between 10 and 25 mg/week for at least 8 weeks.&#xD;
             Concomitant folic/folinic acid at a dose of at least 5 mg/week is to be taken during&#xD;
             the study; patients can start treatment with folic/folinic acid at screening if not&#xD;
             already receiving it.&#xD;
&#xD;
          -  If the patient is currently taking non-steroidal anti-inflammatory drugs (NSAIDs), the&#xD;
             patient must be on a stable dose for at least 4 weeks prior to screening and during&#xD;
             the study.&#xD;
&#xD;
          -  Patients who are ≥18 and ≤75 years of age at screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are rated as Class IV according to the 1991 ACR revised criteria for&#xD;
             classification of global functional status for RA.&#xD;
&#xD;
          -  Patients who have received disease-modifying anti rheumatic drugs (DMARDs), other than&#xD;
             MTX, within a period prior to screening shorter than the washout period appropriate to&#xD;
             the pharmacodynamic profile of the specific drug.&#xD;
&#xD;
          -  Patients who have received immunosuppressive drugs within 4 weeks prior to screening.&#xD;
             Patients on a stable dose of oral corticosteroids (≤10 mg/day prednisone or&#xD;
             equivalent) for ≥4 weeks prior to screening are permitted.&#xD;
&#xD;
          -  Patients who have received intra-articular, intramuscular, intravenous, or epidural&#xD;
             injection of corticosteroids within 4 weeks prior to screening.&#xD;
&#xD;
          -  Patients who have received intra-articular sodium hyaluronate injections within 4&#xD;
             weeks prior to screening.&#xD;
&#xD;
          -  Patients who have received surgical therapy for RA such as synovectomy or arthroplasty&#xD;
             within 6 months prior to screening.&#xD;
&#xD;
          -  Patients who have received arthrocentesis within 4 weeks prior to screening.&#xD;
&#xD;
          -  Patients who have had prior treatment with infliximab.&#xD;
&#xD;
          -  Patients who have had prior treatment with &gt;1 biological drug or &gt;1 protein kinase&#xD;
             inhibitor for RA either as part of clinical management or during a clinical study.&#xD;
&#xD;
          -  Patients who have had prior treatment with tumor necrosis factor alpha (TNF-α)&#xD;
             inhibitors for RA who had lack of efficacy as per clinical judgment (primary failure).&#xD;
             Patients who have discontinued TNF-α inhibitors for RA (other than infliximab) for any&#xD;
             reason other than lack of efficacy are allowed.&#xD;
&#xD;
          -  Presence of chronic or acute infection at screening, including positive result for&#xD;
             active tuberculosis (TB).&#xD;
&#xD;
          -  Patients with an acute infection requiring parenteral antibiotics within 4 weeks of&#xD;
             study dosing or requiring oral/topical antibiotics within 2 weeks of study dosing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Hamden</city>
        <state>Connecticut</state>
        <zip>06518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Doral</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Doral</city>
        <state>Florida</state>
        <zip>33166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33147</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Pinellas Park</city>
        <state>Florida</state>
        <zip>33782</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Tupelo</city>
        <state>Mississippi</state>
        <zip>38801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Freehold</city>
        <state>New Jersey</state>
        <zip>07728</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <zip>28144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Media</city>
        <state>Pennsylvania</state>
        <zip>19063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Fort Mill</city>
        <state>South Carolina</state>
        <zip>29707</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Amarillo</city>
        <state>Texas</state>
        <zip>79124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Baytown</city>
        <state>Texas</state>
        <zip>77521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Beaumont</city>
        <state>Texas</state>
        <zip>77702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <zip>78404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Cypress</city>
        <state>Texas</state>
        <zip>77429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79935</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77089</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77094</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Mesquite</city>
        <state>Texas</state>
        <zip>75150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Nassau Bay</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77479</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <zip>77598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Chesapeake</city>
        <state>Virginia</state>
        <zip>23320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Ostrava</city>
        <zip>702 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Praha 2</city>
        <zip>128 51</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Uherské Hradišté</city>
        <zip>686 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Zlin</city>
        <zip>760 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Białystok</city>
        <zip>15-351</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Katowice</city>
        <zip>40-282</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-582</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-117</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Poznań</city>
        <zip>60-773</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Poznań</city>
        <zip>61-113</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Toruń</city>
        <zip>87-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Warsaw</city>
        <zip>509268</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <zip>00-465</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <zip>00-660</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <zip>02-691</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <zip>03-291</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Łódź</city>
        <zip>90-242</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Łódź</city>
        <zip>91-363</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Caguas</city>
        <zip>00725</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>San Juan</city>
        <zip>00918</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Kemerovo</city>
        <zip>650099</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>125315</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>129327</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630099</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Penza</city>
        <zip>440026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Petrozavodsk</city>
        <zip>185019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Ryazan</city>
        <zip>390026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>190068</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>192242</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>194291</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Tomsk</city>
        <zip>664046</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Vladimir</city>
        <zip>600023</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150003</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150062</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>80028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15701</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15705</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Kharkiv</city>
        <zip>61002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Kharkiv</city>
        <zip>61029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Kharkov</city>
        <zip>61039</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Kyiv</city>
        <zip>01601</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Kyiv</city>
        <zip>04050</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Kyiv</city>
        <zip>04114</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Lviv</city>
        <zip>79014</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Odesa</city>
        <zip>65025</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Ternopil</city>
        <zip>46002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Vinnytsya</city>
        <zip>21000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Vinnytsya</city>
        <zip>21018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Vinnytsya</city>
        <zip>21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Zaporizhzhya</city>
        <zip>69600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Zhytomyr</city>
        <zip>10002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Bury St Edmunds</city>
        <zip>IP33 2QZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Gillingham</city>
        <zip>ME7 5NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Leicester</city>
        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nichi-Iko Investigational Site</name>
      <address>
        <city>Truro</city>
        <zip>TR1 3LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <results_first_submitted>October 4, 2022</results_first_submitted>
  <results_first_submitted_qc>December 28, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 25, 2023</results_first_posted>
  <disposition_first_submitted>May 8, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>December 28, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">January 25, 2023</disposition_first_posted>
  <last_update_submitted>January 26, 2023</last_update_submitted>
  <last_update_submitted_qc>January 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infliximab</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT02990806/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT02990806/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled from 97 investigative site in Czech Republic, Poland, Russia, Spain, Ukraine, and the United States in the study from 19 January 2017 to 20 May 2019.</recruitment_details>
      <pre_assignment_details>The study consisted of 3 stages: the biosimilarity stage (Stage 1), the interchangeability stage (Stage 2), and the safety follow-up stage (Stage 3). A total of 683 participants were randomized in a 2:1 ratio to the Remicade-US and NI-071 groups during Stage 1. In Stage 2 participants in the original Remicade-US group were re-randomized (1:1) to a Remicade-US group and a Switch group (to assess the effects of switching between Remicade-US and NI-071).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Stage 1 and 2: NI-071 Group</title>
          <description>Participants received intravenous (IV) infusion of NI-071 at a dose of 3 milligrams/kilograms (mg/kg) at Weeks 0, 2, 6, 14 during stage 1 and at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 during safety follow-up.</description>
        </group>
        <group group_id="P2">
          <title>Stage 1: Remicade-US Group</title>
          <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
        </group>
        <group group_id="P3">
          <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
          <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
        </group>
        <group group_id="P4">
          <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
          <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Stage 1 (22 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="228"/>
                <participants group_id="P2" count="455">Participants randomized to receive Remicade-US during stage 1.</participants>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="227"/>
                <participants group_id="P2" count="451"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="214"/>
                <participants group_id="P2" count="399"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="56"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Initiated protocol-prohibited medication</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliant with visit schedule and/or protocol</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Required antibiotics resulting in drug interruption &gt;2 weeks</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol deviation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Stage 2 (32 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="214"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="201">399 participants completed stage 1 of Remicade US group, of which 201 participants were randomized to this arm.</participants>
                <participants group_id="P4" count="196">399 participants completed stage 1 of Remicade US group, of which 196 participants were randomized to this arm.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="173"/>
                <participants group_id="P4" count="162"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="28"/>
                <participants group_id="P4" count="34"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Diagnosed with malignancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Required antibiotics resulting in drug interruption</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Initiated protocol-prohibited medication</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliant with visit schedule and/or protocol</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol deviation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ineligible according to Tuberculosis (TB) criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Stage 3 (Safety Follow-up) (8 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="173"/>
                <participants group_id="P4" count="162"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="163"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="162"/>
                <participants group_id="P4" count="152"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliant with visit schedule and/or protocol</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Initiated protocol-prohibited medication</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The intent-to-treat (ITT) population included all participants who were randomized, irrespective of any deviation from the protocol or premature discontinuation.</population>
      <group_list>
        <group group_id="B1">
          <title>Stage 1: NI-071 Group</title>
          <description>Participants received intravenous (IV) infusion of NI-071 at a dose of 3 milligrams/kilograms (mg/kg) at Weeks 0, 2, 6, 14 during stage 1.</description>
        </group>
        <group group_id="B2">
          <title>Stage 1: Remicade-US Group</title>
          <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="228"/>
            <count group_id="B2" value="455"/>
            <count group_id="B3" value="683"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.3" spread="12.0"/>
                    <measurement group_id="B2" value="53.7" spread="11.9"/>
                    <measurement group_id="B3" value="53.6" spread="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="173"/>
                    <measurement group_id="B2" value="372"/>
                    <measurement group_id="B3" value="545"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="153"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="174"/>
                    <measurement group_id="B2" value="350"/>
                    <measurement group_id="B3" value="524"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="211"/>
                    <measurement group_id="B2" value="424"/>
                    <measurement group_id="B3" value="635"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR20-CRP) Response Rate at Week 22</title>
        <description>ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity visual analog scale (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS) (0= no symptoms;100=severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) Health Assessment Questionnaire-Disability Index (HAQ-DI), total score ranging from 0-3 with lower scores meaning less disability, e) CRP.</description>
        <time_frame>At Week 22</time_frame>
        <population>The Intent to Treat (ITT) included all participants who were randomized, irrespective of any deviation from the protocol or premature discontinuation. Data for this outcome measure was planned to be collected and analyzed for Stage 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Remicade-US Group</title>
            <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR20-CRP) Response Rate at Week 22</title>
          <description>ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity visual analog scale (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS) (0= no symptoms;100=severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) Health Assessment Questionnaire-Disability Index (HAQ-DI), total score ranging from 0-3 with lower scores meaning less disability, e) CRP.</description>
          <population>The Intent to Treat (ITT) included all participants who were randomized, irrespective of any deviation from the protocol or premature discontinuation. Data for this outcome measure was planned to be collected and analyzed for Stage 1.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="228"/>
                <count group_id="O2" value="455"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.6" lower_limit="50.1" upper_limit="63.0"/>
                    <measurement group_id="O2" value="53.0" lower_limit="48.4" upper_limit="57.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>A test for equivalence was carried out using an asymmetric margin (-12%, 15%) pre-specified in protocol and a two 1-sided test (TOST) analysis with α=0.05 for each 1-sided statistical test.</non_inferiority_desc>
            <param_type>Percentage difference</param_type>
            <param_value>3.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.04</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.3</ci_lower_limit>
            <ci_upper_limit>11.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Stage 2 and 3: Area Under the Serum Concentration-time Curve Interval (AUCtau) of NI-071 and Remicade US</title>
        <description>AUCtau of NI-071 and Remicade US in stage 2 and 3 was reported. As this was an interchangeability study, the NI-071 and Remicade only were the comparators and then switch study showed same measurement in relationship to the non-switched participants. Hence, combined data was assessed and collected in participants from Remicade US to Switch Group.</description>
        <time_frame>Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose</time_frame>
        <population>Pharmacokinetic (PK) population included all participants in the full analysis set (FAS) in Stage 1 who have valid PK assessments through Stage 2. The FAS included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Stage 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and 3: Area Under the Serum Concentration-time Curve Interval (AUCtau) of NI-071 and Remicade US</title>
          <description>AUCtau of NI-071 and Remicade US in stage 2 and 3 was reported. As this was an interchangeability study, the NI-071 and Remicade only were the comparators and then switch study showed same measurement in relationship to the non-switched participants. Hence, combined data was assessed and collected in participants from Remicade US to Switch Group.</description>
          <population>Pharmacokinetic (PK) population included all participants in the full analysis set (FAS) in Stage 1 who have valid PK assessments through Stage 2. The FAS included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Stage 1.</population>
          <units>hour*nanograms per milliliter (h*ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
                <count group_id="O2" value="146"/>
                <count group_id="O3" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12949622.78" spread="6999387.76"/>
                    <measurement group_id="O2" value="12859923.90" spread="8228379.79"/>
                    <measurement group_id="O3" value="12040415.23" spread="6624933.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Stage 2 and 3: Maximum Observed Serum Concentration (Cmax) of NI-071 and Remicade US</title>
        <description>Cmax of NI-071 and Remicade US was reported. As this was an interchangeability study, the NI-071 and Remicade only were the comparators and then switch study showed same measurement in relationship to the non-switched participants. Hence, combined data was assessed and collected in participants from Remicade US to Switch Group.</description>
        <time_frame>Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose</time_frame>
        <population>PK population included all participants in the FAS in Stage 1 who have valid PK assessments through Stage 2. The FAS included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Stage 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and 3: Maximum Observed Serum Concentration (Cmax) of NI-071 and Remicade US</title>
          <description>Cmax of NI-071 and Remicade US was reported. As this was an interchangeability study, the NI-071 and Remicade only were the comparators and then switch study showed same measurement in relationship to the non-switched participants. Hence, combined data was assessed and collected in participants from Remicade US to Switch Group.</description>
          <population>PK population included all participants in the FAS in Stage 1 who have valid PK assessments through Stage 2. The FAS included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Stage 1.</population>
          <units>nanograms per milliliter (ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="155"/>
                <count group_id="O3" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66298.1" spread="21756.8"/>
                    <measurement group_id="O2" value="63649.0" spread="16566.2"/>
                    <measurement group_id="O3" value="61660.8" spread="18696.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22</title>
        <description>The DAS28-CRP was a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints [assessed on 2-point scale (0=absent; 1=present]), swollen joint count (out of 28 evaluated joints[assessed on 2-point scale (0=absent; 1=present)]), Participant's global assessment of disease activity (assessed on 0-100 mm VAS; where higher scores denotes severe symptoms), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Total Scores on the DAS28-CRP range from 0 to approximately 10 (0=very good, no symptoms; 10=very poor, severe symptoms), where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.</description>
        <time_frame>Baseline, Weeks 2, 6, 14, 18, and 22</time_frame>
        <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Remicade-US Group</title>
            <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22</title>
          <description>The DAS28-CRP was a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints [assessed on 2-point scale (0=absent; 1=present]), swollen joint count (out of 28 evaluated joints[assessed on 2-point scale (0=absent; 1=present)]), Participant's global assessment of disease activity (assessed on 0-100 mm VAS; where higher scores denotes severe symptoms), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Total Scores on the DAS28-CRP range from 0 to approximately 10 (0=very good, no symptoms; 10=very poor, severe symptoms), where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.</description>
          <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="446"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="227"/>
                    <count group_id="O2" value="446"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.816" spread="0.822"/>
                    <measurement group_id="O2" value="5.898" spread="0.787"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="226"/>
                    <count group_id="O2" value="443"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.094" spread="0.881"/>
                    <measurement group_id="O2" value="-1.169" spread="0.931"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="224"/>
                    <count group_id="O2" value="441"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.542" spread="1.041"/>
                    <measurement group_id="O2" value="-1.650" spread="1.114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="218"/>
                    <count group_id="O2" value="423"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.828" spread="1.137"/>
                    <measurement group_id="O2" value="-1.812" spread="1.221"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="215"/>
                    <count group_id="O2" value="407"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.070" spread="1.159"/>
                    <measurement group_id="O2" value="-2.156" spread="1.193"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="217"/>
                    <count group_id="O2" value="404"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.835" spread="1.247"/>
                    <measurement group_id="O2" value="-1.978" spread="1.209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</title>
        <description>The DAS28-CRP was a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints [assessed on 2-point scale (0=absent; 1=present]), swollen joint count (out of 28 evaluated joints[assessed on 2-point scale (0=absent; 1=present)]), Participant's global assessment of disease activity (assessed on 0-100 mm VAS; where higher scores denotes severe symptoms), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Total Scores on the DAS28-CRP range from 0 to approximately 10 (0=very good, no symptoms; 10=very poor, severe symptoms), where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.</description>
        <time_frame>Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
        <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants from Stage 1 continued to receive IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during Stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</title>
          <description>The DAS28-CRP was a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints [assessed on 2-point scale (0=absent; 1=present]), swollen joint count (out of 28 evaluated joints[assessed on 2-point scale (0=absent; 1=present)]), Participant's global assessment of disease activity (assessed on 0-100 mm VAS; where higher scores denotes severe symptoms), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Total Scores on the DAS28-CRP range from 0 to approximately 10 (0=very good, no symptoms; 10=very poor, severe symptoms), where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.</description>
          <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="198"/>
                <count group_id="O3" value="194"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="198"/>
                    <count group_id="O3" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.199" spread="1.238"/>
                    <measurement group_id="O2" value="-2.317" spread="1.227"/>
                    <measurement group_id="O3" value="-2.192" spread="1.180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="189"/>
                    <count group_id="O3" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.106" spread="1.269"/>
                    <measurement group_id="O2" value="-2.298" spread="1.251"/>
                    <measurement group_id="O3" value="-2.092" spread="1.230"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 34</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                    <count group_id="O2" value="182"/>
                    <count group_id="O3" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.379" spread="1.251"/>
                    <measurement group_id="O2" value="-2.586" spread="1.187"/>
                    <measurement group_id="O3" value="-2.446" spread="1.266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 38</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="190"/>
                    <count group_id="O2" value="183"/>
                    <count group_id="O3" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.281" spread="1.234"/>
                    <measurement group_id="O2" value="-2.331" spread="1.258"/>
                    <measurement group_id="O3" value="-2.321" spread="1.376"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 42</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="182"/>
                    <count group_id="O2" value="181"/>
                    <count group_id="O3" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.415" spread="1.228"/>
                    <measurement group_id="O2" value="-2.630" spread="1.226"/>
                    <measurement group_id="O3" value="-2.519" spread="1.236"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 46</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="176"/>
                    <count group_id="O3" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.242" spread="1.203"/>
                    <measurement group_id="O2" value="-2.387" spread="1.270"/>
                    <measurement group_id="O3" value="-2.207" spread="1.217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="171"/>
                    <count group_id="O3" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.444" spread="1.156"/>
                    <measurement group_id="O2" value="-2.679" spread="1.245"/>
                    <measurement group_id="O3" value="-2.551" spread="1.172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 54</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="167"/>
                    <count group_id="O2" value="165"/>
                    <count group_id="O3" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.443" spread="1.212"/>
                    <measurement group_id="O2" value="-2.462" spread="1.189"/>
                    <measurement group_id="O3" value="-2.247" spread="1.298"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 58</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="165"/>
                    <count group_id="O2" value="162"/>
                    <count group_id="O3" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.568" spread="1.211"/>
                    <measurement group_id="O2" value="-2.739" spread="1.236"/>
                    <measurement group_id="O3" value="-2.450" spread="1.227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 62</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="162"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.466" spread="1.238"/>
                    <measurement group_id="O2" value="-2.605" spread="1.276"/>
                    <measurement group_id="O3" value="-2.404" spread="1.327"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22</title>
        <description>DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (millimeters per hour) and GH recorded on 100mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). DAS28 (ESR) was calculated as 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.70*ln(ESR [mm/hour] + 0.014*GH [mm]; where, TJC28 = number of painful joints out of 28 joints, SJC28 = number of swollen joints out of 28 joints, GH = score of the participant global assessment of disease activity, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. A negative change from baseline indicates improvement in disease activity.</description>
        <time_frame>Baseline, Weeks 2, 6, 14, 18, and 22</time_frame>
        <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Remicade-US Group</title>
            <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22</title>
          <description>DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (millimeters per hour) and GH recorded on 100mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). DAS28 (ESR) was calculated as 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.70*ln(ESR [mm/hour] + 0.014*GH [mm]; where, TJC28 = number of painful joints out of 28 joints, SJC28 = number of swollen joints out of 28 joints, GH = score of the participant global assessment of disease activity, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. A negative change from baseline indicates improvement in disease activity.</description>
          <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="445"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="227"/>
                    <count group_id="O2" value="445"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.552" spread="0.861"/>
                    <measurement group_id="O2" value="6.655" spread="0.755"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="225"/>
                    <count group_id="O2" value="442"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.060" spread="0.915"/>
                    <measurement group_id="O2" value="-1.161" spread="0.893"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="224"/>
                    <count group_id="O2" value="437"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.588" spread="1.112"/>
                    <measurement group_id="O2" value="-1.778" spread="1.174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="216"/>
                    <count group_id="O2" value="420"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.002" spread="1.254"/>
                    <measurement group_id="O2" value="-1.951" spread="1.266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="215"/>
                    <count group_id="O2" value="406"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.291" spread="1.300"/>
                    <measurement group_id="O2" value="-2.345" spread="1.278"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="217"/>
                    <count group_id="O2" value="402"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.060" spread="1.386"/>
                    <measurement group_id="O2" value="-2.195" spread="1.326"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</title>
        <description>DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (millimeters per hour) and Patient Global Assessment (PtGA) recorded on 100mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). DAS28 (ESR) was calculated as 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.70*ln(ESR [mm/hour] + 0.014*GH [mm]; where, TJC28 = number of painful joints out of 28 joints, SJC28 = number of swollen joints out of 28 joints, GH = score of the participant global assessment of disease activity, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. A negative change from baseline indicates improvement in disease activity.</description>
        <time_frame>Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
        <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants from stage 1 continued to receive IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</title>
          <description>DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (millimeters per hour) and Patient Global Assessment (PtGA) recorded on 100mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). DAS28 (ESR) was calculated as 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.70*ln(ESR [mm/hour] + 0.014*GH [mm]; where, TJC28 = number of painful joints out of 28 joints, SJC28 = number of swollen joints out of 28 joints, GH = score of the participant global assessment of disease activity, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. A negative change from baseline indicates improvement in disease activity.</description>
          <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="198"/>
                <count group_id="O3" value="193"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="198"/>
                    <count group_id="O3" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.387" spread="1.393"/>
                    <measurement group_id="O2" value="-2.533" spread="1.395"/>
                    <measurement group_id="O3" value="-2.375" spread="1.304"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="189"/>
                    <count group_id="O3" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.346" spread="1.457"/>
                    <measurement group_id="O2" value="-2.533" spread="1.349"/>
                    <measurement group_id="O3" value="-2.261" spread="1.374"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 34</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                    <count group_id="O2" value="182"/>
                    <count group_id="O3" value="183"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.602" spread="1.416"/>
                    <measurement group_id="O2" value="-2.864" spread="1.303"/>
                    <measurement group_id="O3" value="-2.609" spread="1.376"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 38</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="190"/>
                    <count group_id="O2" value="183"/>
                    <count group_id="O3" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.516" spread="1.478"/>
                    <measurement group_id="O2" value="-2.535" spread="1.314"/>
                    <measurement group_id="O3" value="-2.493" spread="1.518"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 42</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="182"/>
                    <count group_id="O2" value="181"/>
                    <count group_id="O3" value="170"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.650" spread="1.372"/>
                    <measurement group_id="O2" value="-2.847" spread="1.258"/>
                    <measurement group_id="O3" value="-2.691" spread="1.433"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 46</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="175"/>
                    <count group_id="O3" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.494" spread="1.352"/>
                    <measurement group_id="O2" value="-2.625" spread="1.322"/>
                    <measurement group_id="O3" value="-2.406" spread="1.364"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="171"/>
                    <count group_id="O3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.649" spread="1.291"/>
                    <measurement group_id="O2" value="-2.964" spread="1.302"/>
                    <measurement group_id="O3" value="-2.708" spread="1.303"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 54</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="167"/>
                    <count group_id="O2" value="165"/>
                    <count group_id="O3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.619" spread="1.385"/>
                    <measurement group_id="O2" value="-2.662" spread="1.221"/>
                    <measurement group_id="O3" value="-2.403" spread="1.410"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 58</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="165"/>
                    <count group_id="O2" value="162"/>
                    <count group_id="O3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.764" spread="1.385"/>
                    <measurement group_id="O2" value="-2.985" spread="1.337"/>
                    <measurement group_id="O3" value="-2.617" spread="1.376"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 62</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="162"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="153"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.663" spread="1.439"/>
                    <measurement group_id="O2" value="-2.864" spread="1.371"/>
                    <measurement group_id="O3" value="-2.574" spread="1.470"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate</title>
        <description>ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) CRP.</description>
        <time_frame>At Weeks 2, 6, 14, 18, and 22</time_frame>
        <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. Last observation carried forward (LOCF) method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Remicade-US Group</title>
            <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate</title>
          <description>ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) CRP.</description>
          <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. Last observation carried forward (LOCF) method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="446"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.3" lower_limit="25.2" upper_limit="37.3"/>
                    <measurement group_id="O2" value="32.5" lower_limit="28.2" upper_limit="36.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.1" lower_limit="40.6" upper_limit="53.6"/>
                    <measurement group_id="O2" value="54.3" lower_limit="49.6" upper_limit="58.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.4" lower_limit="49.9" upper_limit="62.8"/>
                    <measurement group_id="O2" value="51.1" lower_limit="46.5" upper_limit="55.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.6" lower_limit="56.3" upper_limit="68.9"/>
                    <measurement group_id="O2" value="61.7" lower_limit="57.1" upper_limit="66.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.8" lower_limit="50.4" upper_limit="63.3"/>
                    <measurement group_id="O2" value="54.5" lower_limit="49.9" upper_limit="59.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate</title>
        <description>ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) CRP.</description>
        <time_frame>At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
        <population>Full Analysis Set population included participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Overall Number of Participants indicates the number of patients with FAS. The patient number of FAS is the number of patients evaluated at baseline, which is different from number of patients who started Stage 2 or 3. ACR 20 (CRP) response rate/visit was calculated based on the number of patients achieving ACR20 criteria divided by FAS number.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants from stage 1 continued to receive IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate</title>
          <description>ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) CRP.</description>
          <population>Full Analysis Set population included participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Overall Number of Participants indicates the number of patients with FAS. The patient number of FAS is the number of patients evaluated at baseline, which is different from number of patients who started Stage 2 or 3. ACR 20 (CRP) response rate/visit was calculated based on the number of patients achieving ACR20 criteria divided by FAS number.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="248"/>
                <count group_id="O3" value="197"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.6" lower_limit="56.3" upper_limit="68.9"/>
                    <measurement group_id="O2" value="56.5" lower_limit="50.3" upper_limit="62.6"/>
                    <measurement group_id="O3" value="61.9" lower_limit="55.1" upper_limit="68.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.5" lower_limit="49.0" upper_limit="62.0"/>
                    <measurement group_id="O2" value="48.8" lower_limit="42.6" upper_limit="55.0"/>
                    <measurement group_id="O3" value="57.9" lower_limit="51.0" upper_limit="64.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 34</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.7" lower_limit="55.3" upper_limit="68.0"/>
                    <measurement group_id="O2" value="55.6" lower_limit="49.5" upper_limit="61.8"/>
                    <measurement group_id="O3" value="61.4" lower_limit="54.6" upper_limit="68.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 38</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.0" lower_limit="45.5" upper_limit="58.5"/>
                    <measurement group_id="O2" value="47.6" lower_limit="41.4" upper_limit="53.8"/>
                    <measurement group_id="O3" value="57.9" lower_limit="51.0" upper_limit="64.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.6" lower_limit="48.1" upper_limit="61.1"/>
                    <measurement group_id="O2" value="53.6" lower_limit="47.4" upper_limit="59.8"/>
                    <measurement group_id="O3" value="59.4" lower_limit="52.5" upper_limit="66.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 46</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.1" lower_limit="44.6" upper_limit="57.6"/>
                    <measurement group_id="O2" value="48.0" lower_limit="41.8" upper_limit="54.2"/>
                    <measurement group_id="O3" value="51.3" lower_limit="44.3" upper_limit="58.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.2" lower_limit="47.7" upper_limit="60.7"/>
                    <measurement group_id="O2" value="50.0" lower_limit="43.8" upper_limit="56.2"/>
                    <measurement group_id="O3" value="59.9" lower_limit="53.1" upper_limit="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.4" lower_limit="45.9" upper_limit="58.9"/>
                    <measurement group_id="O2" value="47.2" lower_limit="41.0" upper_limit="53.4"/>
                    <measurement group_id="O3" value="49.2" lower_limit="42.3" upper_limit="56.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 58</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.4" lower_limit="45.9" upper_limit="58.9"/>
                    <measurement group_id="O2" value="46.4" lower_limit="40.2" upper_limit="52.6"/>
                    <measurement group_id="O3" value="56.9" lower_limit="49.9" upper_limit="63.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 62</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.0" lower_limit="45.5" upper_limit="58.5"/>
                    <measurement group_id="O2" value="46.4" lower_limit="40.2" upper_limit="52.6"/>
                    <measurement group_id="O3" value="55.3" lower_limit="48.4" upper_limit="62.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Percentage of Participants Who Achieved Greater Than or Equal to (&gt;=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)</title>
        <description>ACR20-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) erythrocyte sedimentation rate (ESR).</description>
        <time_frame>At Weeks 2, 6, 14, 18, and 22</time_frame>
        <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. LOCF method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Remicade-US Group</title>
            <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Percentage of Participants Who Achieved Greater Than or Equal to (&gt;=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)</title>
          <description>ACR20-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) erythrocyte sedimentation rate (ESR).</description>
          <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. LOCF method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="446"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.1" lower_limit="23.2" upper_limit="35.0"/>
                    <measurement group_id="O2" value="31.8" lower_limit="27.5" upper_limit="36.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.7" lower_limit="40.2" upper_limit="53.2"/>
                    <measurement group_id="O2" value="54.3" lower_limit="49.6" upper_limit="58.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.8" lower_limit="50.4" upper_limit="63.3"/>
                    <measurement group_id="O2" value="52.2" lower_limit="47.6" upper_limit="56.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.6" lower_limit="56.3" upper_limit="68.9"/>
                    <measurement group_id="O2" value="62.3" lower_limit="57.8" upper_limit="66.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.9" lower_limit="49.5" upper_limit="62.4"/>
                    <measurement group_id="O2" value="56.3" lower_limit="51.7" upper_limit="60.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (&gt;=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)</title>
        <description>ACR20-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) (ESR.</description>
        <time_frame>At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
        <population>Full Analysis Set population included participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Overall Number of Participants indicates the number of patients with FAS. The patient number of FAS is the number of patients evaluated at baseline, which is different from number of patients who started Stage 2 or 3. ACR 20 (CRP) response rate/visit was calculated based on the number of patients achieving ACR20 criteria divided by FAS number.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants from stage 1 continued to receive IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (&gt;=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)</title>
          <description>ACR20-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) (ESR.</description>
          <population>Full Analysis Set population included participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Overall Number of Participants indicates the number of patients with FAS. The patient number of FAS is the number of patients evaluated at baseline, which is different from number of patients who started Stage 2 or 3. ACR 20 (CRP) response rate/visit was calculated based on the number of patients achieving ACR20 criteria divided by FAS number.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="248"/>
                <count group_id="O3" value="197"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.8" lower_limit="54.4" upper_limit="67.1"/>
                    <measurement group_id="O2" value="55.6" lower_limit="49.5" upper_limit="61.8"/>
                    <measurement group_id="O3" value="62.4" lower_limit="55.7" upper_limit="69.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.1" lower_limit="51.7" upper_limit="64.6"/>
                    <measurement group_id="O2" value="50.0" lower_limit="43.8" upper_limit="56.2"/>
                    <measurement group_id="O3" value="57.4" lower_limit="50.5" upper_limit="64.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 34</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.1" lower_limit="55.8" upper_limit="68.4"/>
                    <measurement group_id="O2" value="56.9" lower_limit="50.7" upper_limit="63.0"/>
                    <measurement group_id="O3" value="61.4" lower_limit="54.6" upper_limit="68.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 38</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.4" lower_limit="49.9" upper_limit="62.8"/>
                    <measurement group_id="O2" value="48.8" lower_limit="42.6" upper_limit="55.0"/>
                    <measurement group_id="O3" value="59.4" lower_limit="52.5" upper_limit="66.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.3" lower_limit="50.8" upper_limit="63.7"/>
                    <measurement group_id="O2" value="54.4" lower_limit="48.2" upper_limit="60.6"/>
                    <measurement group_id="O3" value="60.9" lower_limit="54.1" upper_limit="67.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 46</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.7" lower_limit="47.3" upper_limit="60.2"/>
                    <measurement group_id="O2" value="50.0" lower_limit="43.8" upper_limit="56.2"/>
                    <measurement group_id="O3" value="54.3" lower_limit="47.4" upper_limit="61.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.4" lower_limit="49.9" upper_limit="62.8"/>
                    <measurement group_id="O2" value="50.8" lower_limit="44.6" upper_limit="57.0"/>
                    <measurement group_id="O3" value="59.4" lower_limit="52.5" upper_limit="66.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.6" lower_limit="48.1" upper_limit="61.1"/>
                    <measurement group_id="O2" value="47.2" lower_limit="41.0" upper_limit="53.4"/>
                    <measurement group_id="O3" value="50.8" lower_limit="43.8" upper_limit="57.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 58</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.2" lower_limit="47.7" upper_limit="60.7"/>
                    <measurement group_id="O2" value="48.8" lower_limit="42.6" upper_limit="55.0"/>
                    <measurement group_id="O3" value="55.8" lower_limit="48.9" upper_limit="62.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 62</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.4" lower_limit="45.9" upper_limit="58.9"/>
                    <measurement group_id="O2" value="47.2" lower_limit="41.0" upper_limit="53.4"/>
                    <measurement group_id="O3" value="54.3" lower_limit="47.4" upper_limit="61.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Percentage of Participants Who Achieved &gt;=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate</title>
        <description>ACR50 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.</description>
        <time_frame>At Weeks 2, 6, 14, 18, and 22</time_frame>
        <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. LOCF method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Remicade-US Group</title>
            <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Percentage of Participants Who Achieved &gt;=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate</title>
          <description>ACR50 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.</description>
          <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. LOCF method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="446"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4" lower_limit="4.8" upper_limit="12.0"/>
                    <measurement group_id="O2" value="8.3" lower_limit="5.7" upper_limit="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.3" lower_limit="11.5" upper_limit="21.1"/>
                    <measurement group_id="O2" value="19.1" lower_limit="15.4" upper_limit="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.7" lower_limit="19.1" upper_limit="30.3"/>
                    <measurement group_id="O2" value="21.3" lower_limit="17.5" upper_limit="25.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.2" lower_limit="26.1" upper_limit="38.2"/>
                    <measurement group_id="O2" value="30.9" lower_limit="26.7" upper_limit="35.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8" lower_limit="21.9" upper_limit="33.6"/>
                    <measurement group_id="O2" value="25.6" lower_limit="21.5" upper_limit="29.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2 and 3: Percentage of Participants Who Achieved &gt;=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate</title>
        <description>ACR50 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.</description>
        <time_frame>At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
        <population>Full Analysis Set population included participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR50 efficacy assessment. Overall Number of Participants indicates the number of patients with FAS. The patient number of FAS is the number of patients evaluated at baseline, which is different from number of patients who started Stage 2 or 3. ACR 50 (CRP) response rate/visit was calculated based on the number of patients achieving ACR50 criteria divided by FAS number.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants from stage 1 continued to receive IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and 3: Percentage of Participants Who Achieved &gt;=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate</title>
          <description>ACR50 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.</description>
          <population>Full Analysis Set population included participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR50 efficacy assessment. Overall Number of Participants indicates the number of patients with FAS. The patient number of FAS is the number of patients evaluated at baseline, which is different from number of patients who started Stage 2 or 3. ACR 50 (CRP) response rate/visit was calculated based on the number of patients achieving ACR50 criteria divided by FAS number.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="248"/>
                <count group_id="O3" value="446"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.4" lower_limit="28.2" upper_limit="40.5"/>
                    <measurement group_id="O2" value="32.3" lower_limit="26.4" upper_limit="38.1"/>
                    <measurement group_id="O3" value="31.0" lower_limit="24.5" upper_limit="37.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.0" lower_limit="24.0" upper_limit="35.9"/>
                    <measurement group_id="O2" value="28.6" lower_limit="23.0" upper_limit="34.3"/>
                    <measurement group_id="O3" value="29.4" lower_limit="23.1" upper_limit="35.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 34</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.2" lower_limit="29.0" upper_limit="41.5"/>
                    <measurement group_id="O2" value="34.3" lower_limit="28.4" upper_limit="40.2"/>
                    <measurement group_id="O3" value="39.1" lower_limit="32.3" upper_limit="45.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 38</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.3" lower_limit="25.2" upper_limit="37.3"/>
                    <measurement group_id="O2" value="30.2" lower_limit="24.5" upper_limit="36.0"/>
                    <measurement group_id="O3" value="34.0" lower_limit="27.4" upper_limit="40.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.5" lower_limit="27.3" upper_limit="39.6"/>
                    <measurement group_id="O2" value="36.7" lower_limit="30.7" upper_limit="42.7"/>
                    <measurement group_id="O3" value="40.6" lower_limit="33.8" upper_limit="47.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 46</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.8" lower_limit="24.8" upper_limit="36.8"/>
                    <measurement group_id="O2" value="31.5" lower_limit="25.7" upper_limit="37.2"/>
                    <measurement group_id="O3" value="30.5" lower_limit="24.0" upper_limit="36.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.0" lower_limit="30.7" upper_limit="43.3"/>
                    <measurement group_id="O2" value="34.7" lower_limit="28.8" upper_limit="40.6"/>
                    <measurement group_id="O3" value="35.5" lower_limit="28.8" upper_limit="42.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.6" lower_limit="30.3" upper_limit="42.8"/>
                    <measurement group_id="O2" value="28.6" lower_limit="23.0" upper_limit="34.3"/>
                    <measurement group_id="O3" value="32.5" lower_limit="25.9" upper_limit="39.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 58</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.6" lower_limit="26.5" upper_limit="38.7"/>
                    <measurement group_id="O2" value="32.7" lower_limit="26.8" upper_limit="38.5"/>
                    <measurement group_id="O3" value="34.0" lower_limit="27.4" upper_limit="40.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 62</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.8" lower_limit="24.8" upper_limit="36.8"/>
                    <measurement group_id="O2" value="32.7" lower_limit="26.8" upper_limit="38.5"/>
                    <measurement group_id="O3" value="28.4" lower_limit="22.1" upper_limit="34.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Percentage of Participants Who Achieved &gt;=50% American College of Rheumatology (ACR50) Response Using ESR</title>
        <description>ACR50-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.</description>
        <time_frame>At Weeks 2, 6, 14, 18, and 22</time_frame>
        <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. LOCF method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Remicade-US Group</title>
            <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Percentage of Participants Who Achieved &gt;=50% American College of Rheumatology (ACR50) Response Using ESR</title>
          <description>ACR50-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.</description>
          <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. LOCF method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="446"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" lower_limit="3.4" upper_limit="9.8"/>
                    <measurement group_id="O2" value="6.7" lower_limit="4.4" upper_limit="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" lower_limit="10.0" upper_limit="19.1"/>
                    <measurement group_id="O2" value="17.9" lower_limit="14.4" upper_limit="21.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3" lower_limit="17.8" upper_limit="28.9"/>
                    <measurement group_id="O2" value="21.7" lower_limit="17.9" upper_limit="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.7" lower_limit="25.7" upper_limit="37.8"/>
                    <measurement group_id="O2" value="29.6" lower_limit="25.4" upper_limit="33.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8" lower_limit="21.9" upper_limit="33.6"/>
                    <measurement group_id="O2" value="26.7" lower_limit="22.6" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2 and Stage 3: Percentage of Participants Who Achieved &gt;=50% American College of Rheumatology (ACR50) Response Using ESR</title>
        <description>ACR50-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.</description>
        <time_frame>At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
        <population>Full Analysis Set population included participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR50 efficacy assessment. Overall Number of Participants indicates the number of patients with FAS. The patient number of FAS is the number of patients evaluated at baseline, which is different from number of patients who started Stage 2 or 3. ACR 50 (CRP) response rate/visit was calculated based on the number of patients achieving ACR50 criteria divided by FAS number.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants from stage 1 continued to receive IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and Stage 3: Percentage of Participants Who Achieved &gt;=50% American College of Rheumatology (ACR50) Response Using ESR</title>
          <description>ACR50-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.</description>
          <population>Full Analysis Set population included participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR50 efficacy assessment. Overall Number of Participants indicates the number of patients with FAS. The patient number of FAS is the number of patients evaluated at baseline, which is different from number of patients who started Stage 2 or 3. ACR 50 (CRP) response rate/visit was calculated based on the number of patients achieving ACR50 criteria divided by FAS number.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="248"/>
                <count group_id="O3" value="197"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.0" lower_limit="26.9" upper_limit="39.2"/>
                    <measurement group_id="O2" value="31.9" lower_limit="26.1" upper_limit="37.7"/>
                    <measurement group_id="O3" value="30.5" lower_limit="24.0" upper_limit="36.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.1" lower_limit="23.2" upper_limit="35.0"/>
                    <measurement group_id="O2" value="28.2" lower_limit="22.6" upper_limit="33.8"/>
                    <measurement group_id="O3" value="28.4" lower_limit="22.1" upper_limit="34.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 34</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.2" lower_limit="29.0" upper_limit="41.5"/>
                    <measurement group_id="O2" value="34.7" lower_limit="28.8" upper_limit="40.6"/>
                    <measurement group_id="O3" value="39.1" lower_limit="32.3" upper_limit="45.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 38</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.2" lower_limit="26.1" upper_limit="38.2"/>
                    <measurement group_id="O2" value="30.6" lower_limit="24.9" upper_limit="36.4"/>
                    <measurement group_id="O3" value="32.5" lower_limit="25.9" upper_limit="39.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.5" lower_limit="27.3" upper_limit="39.6"/>
                    <measurement group_id="O2" value="36.7" lower_limit="30.7" upper_limit="42.7"/>
                    <measurement group_id="O3" value="37.1" lower_limit="30.3" upper_limit="43.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 46</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.5" lower_limit="23.6" upper_limit="35.4"/>
                    <measurement group_id="O2" value="31.5" lower_limit="25.7" upper_limit="37.2"/>
                    <measurement group_id="O3" value="29.4" lower_limit="23.1" upper_limit="35.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.8" lower_limit="28.6" upper_limit="41.0"/>
                    <measurement group_id="O2" value="34.3" lower_limit="28.4" upper_limit="40.2"/>
                    <measurement group_id="O3" value="34.5" lower_limit="27.9" upper_limit="41.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.1" lower_limit="29.9" upper_limit="42.4"/>
                    <measurement group_id="O2" value="28.6" lower_limit="23.0" upper_limit="34.3"/>
                    <measurement group_id="O3" value="29.4" lower_limit="23.1" upper_limit="35.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 58</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.6" lower_limit="26.5" upper_limit="38.7"/>
                    <measurement group_id="O2" value="32.3" lower_limit="26.4" upper_limit="38.1"/>
                    <measurement group_id="O3" value="33.5" lower_limit="26.9" upper_limit="40.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 62</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.1" lower_limit="23.2" upper_limit="35.0"/>
                    <measurement group_id="O2" value="32.7" lower_limit="26.8" upper_limit="38.5"/>
                    <measurement group_id="O3" value="27.9" lower_limit="21.7" upper_limit="34.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Percentage of Participants Who Achieved &gt;=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate</title>
        <description>ACR70 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.</description>
        <time_frame>At Weeks 2, 6, 14, 18, and 22</time_frame>
        <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. LOCF method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Remicade-US Group</title>
            <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Percentage of Participants Who Achieved &gt;=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate</title>
          <description>ACR70 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.</description>
          <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. LOCF method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="446"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" lower_limit="0.0" upper_limit="2.1"/>
                    <measurement group_id="O2" value="1.3" lower_limit="0.3" upper_limit="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" lower_limit="3.4" upper_limit="9.8"/>
                    <measurement group_id="O2" value="7.2" lower_limit="4.8" upper_limit="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" lower_limit="6.9" upper_limit="15.1"/>
                    <measurement group_id="O2" value="7.8" lower_limit="5.4" upper_limit="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.3" upper_limit="19.6"/>
                    <measurement group_id="O2" value="11.7" lower_limit="8.7" upper_limit="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" lower_limit="6.6" upper_limit="14.6"/>
                    <measurement group_id="O2" value="12.1" lower_limit="9.1" upper_limit="15.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2 and 3: Percentage of Participants Who Achieved &gt;=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate</title>
        <description>ACR70 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.</description>
        <time_frame>At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
        <population>Full Analysis Set population included participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR70 efficacy assessment. Overall Number of Participants indicates the number of patients with FAS. The patient number of FAS is the number of patients evaluated at baseline, which is different from number of patients who started Stage 2 or 3. ACR 70 (CRP) response rate/visit was calculated based on the number of patients achieving ACR70 criteria divided by FAS number.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants from stage 1 continued to receive IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and 3: Percentage of Participants Who Achieved &gt;=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate</title>
          <description>ACR70 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.</description>
          <population>Full Analysis Set population included participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR70 efficacy assessment. Overall Number of Participants indicates the number of patients with FAS. The patient number of FAS is the number of patients evaluated at baseline, which is different from number of patients who started Stage 2 or 3. ACR 70 (CRP) response rate/visit was calculated based on the number of patients achieving ACR70 criteria divided by FAS number.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="248"/>
                <count group_id="O3" value="197"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.3" lower_limit="11.5" upper_limit="21.1"/>
                    <measurement group_id="O2" value="14.5" lower_limit="10.1" upper_limit="18.9"/>
                    <measurement group_id="O3" value="13.2" lower_limit="8.5" upper_limit="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.3" lower_limit="11.5" upper_limit="21.1"/>
                    <measurement group_id="O2" value="15.3" lower_limit="10.8" upper_limit="19.8"/>
                    <measurement group_id="O3" value="13.2" lower_limit="8.5" upper_limit="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 34</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1" lower_limit="13.1" upper_limit="23.1"/>
                    <measurement group_id="O2" value="18.1" lower_limit="13.3" upper_limit="22.9"/>
                    <measurement group_id="O3" value="20.8" lower_limit="15.1" upper_limit="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 38</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.6" lower_limit="12.7" upper_limit="22.6"/>
                    <measurement group_id="O2" value="15.7" lower_limit="11.2" upper_limit="20.3"/>
                    <measurement group_id="O3" value="14.7" lower_limit="9.8" upper_limit="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.2" lower_limit="12.3" upper_limit="22.1"/>
                    <measurement group_id="O2" value="18.5" lower_limit="13.7" upper_limit="23.4"/>
                    <measurement group_id="O3" value="18.3" lower_limit="12.9" upper_limit="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 46</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.3" upper_limit="19.6"/>
                    <measurement group_id="O2" value="18.5" lower_limit="13.7" upper_limit="23.4"/>
                    <measurement group_id="O3" value="14.7" lower_limit="9.8" upper_limit="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.0" lower_limit="16.6" upper_limit="27.4"/>
                    <measurement group_id="O2" value="23.0" lower_limit="17.7" upper_limit="28.2"/>
                    <measurement group_id="O3" value="18.3" lower_limit="12.9" upper_limit="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1" lower_limit="13.1" upper_limit="23.1"/>
                    <measurement group_id="O2" value="14.9" lower_limit="10.5" upper_limit="19.4"/>
                    <measurement group_id="O3" value="15.7" lower_limit="10.7" upper_limit="20.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 58</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.9" lower_limit="13.8" upper_limit="24.0"/>
                    <measurement group_id="O2" value="19.8" lower_limit="14.8" upper_limit="24.7"/>
                    <measurement group_id="O3" value="16.2" lower_limit="11.1" upper_limit="21.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 62</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.2" lower_limit="12.3" upper_limit="22.1"/>
                    <measurement group_id="O2" value="18.5" lower_limit="13.7" upper_limit="23.4"/>
                    <measurement group_id="O3" value="13.2" lower_limit="8.5" upper_limit="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Percentage of Participants Who Achieved &gt;=70% American College of Rheumatology (ACR70) Response Using ESR</title>
        <description>ACR70-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.</description>
        <time_frame>At Weeks 2, 6, 14, 18, 22</time_frame>
        <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. LOCF method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Remicade-US Group</title>
            <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Percentage of Participants Who Achieved &gt;=70% American College of Rheumatology (ACR70) Response Using ESR</title>
          <description>ACR70-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.</description>
          <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. LOCF method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="446"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" lower_limit="0.0" upper_limit="2.1"/>
                    <measurement group_id="O2" value="1.1" lower_limit="0.1" upper_limit="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" lower_limit="2.7" upper_limit="8.7"/>
                    <measurement group_id="O2" value="6.1" lower_limit="3.8" upper_limit="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7" lower_limit="5.8" upper_limit="13.5"/>
                    <measurement group_id="O2" value="7.4" lower_limit="5.0" upper_limit="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" lower_limit="10.0" upper_limit="19.1"/>
                    <measurement group_id="O2" value="11.0" lower_limit="8.1" upper_limit="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" lower_limit="6.9" upper_limit="15.1"/>
                    <measurement group_id="O2" value="11.2" lower_limit="8.3" upper_limit="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2 and 3: Percentage of Participants Who Achieved &gt;=70% American College of Rheumatology (ACR70) Response Using ESR</title>
        <description>ACR70-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.</description>
        <time_frame>At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
        <population>Full Analysis Set population included participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR70 efficacy assessment. Overall Number of Participants indicates the number of patients with FAS. The patient number of FAS is the number of patients evaluated at baseline, which is different from number of patients who started Stage 2 or 3. ACR 70 (CRP) response rate/visit was calculated based on the number of patients achieving ACR70 criteria divided by FAS number.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants from stage 1 continued to receive IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and 3: Percentage of Participants Who Achieved &gt;=70% American College of Rheumatology (ACR70) Response Using ESR</title>
          <description>ACR70-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.</description>
          <population>Full Analysis Set population included participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR70 efficacy assessment. Overall Number of Participants indicates the number of patients with FAS. The patient number of FAS is the number of patients evaluated at baseline, which is different from number of patients who started Stage 2 or 3. ACR 70 (CRP) response rate/visit was calculated based on the number of patients achieving ACR70 criteria divided by FAS number.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="248"/>
                <count group_id="O3" value="197"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" lower_limit="10.7" upper_limit="20.1"/>
                    <measurement group_id="O2" value="15.3" lower_limit="10.8" upper_limit="19.8"/>
                    <measurement group_id="O3" value="12.7" lower_limit="8.0" upper_limit="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" lower_limit="10.7" upper_limit="20.1"/>
                    <measurement group_id="O2" value="14.1" lower_limit="9.8" upper_limit="18.4"/>
                    <measurement group_id="O3" value="11.7" lower_limit="7.2" upper_limit="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 34</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="11.9" upper_limit="21.6"/>
                    <measurement group_id="O2" value="16.9" lower_limit="12.3" upper_limit="21.6"/>
                    <measurement group_id="O3" value="19.3" lower_limit="13.8" upper_limit="24.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 38</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.3" lower_limit="11.5" upper_limit="21.1"/>
                    <measurement group_id="O2" value="16.1" lower_limit="11.6" upper_limit="20.7"/>
                    <measurement group_id="O3" value="14.2" lower_limit="9.3" upper_limit="19.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" lower_limit="10.0" upper_limit="19.1"/>
                    <measurement group_id="O2" value="17.3" lower_limit="12.6" upper_limit="22.1"/>
                    <measurement group_id="O3" value="15.7" lower_limit="10.7" upper_limit="20.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 46</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" lower_limit="10.7" upper_limit="20.1"/>
                    <measurement group_id="O2" value="16.9" lower_limit="12.3" upper_limit="21.6"/>
                    <measurement group_id="O3" value="13.2" lower_limit="8.5" upper_limit="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7" lower_limit="15.4" upper_limit="26.0"/>
                    <measurement group_id="O2" value="22.6" lower_limit="17.4" upper_limit="27.8"/>
                    <measurement group_id="O3" value="15.7" lower_limit="10.7" upper_limit="20.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.2" lower_limit="12.3" upper_limit="22.1"/>
                    <measurement group_id="O2" value="13.3" lower_limit="9.1" upper_limit="17.5"/>
                    <measurement group_id="O3" value="13.7" lower_limit="8.9" upper_limit="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 58</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.2" lower_limit="12.3" upper_limit="22.1"/>
                    <measurement group_id="O2" value="18.1" lower_limit="13.3" upper_limit="22.9"/>
                    <measurement group_id="O3" value="14.7" lower_limit="9.8" upper_limit="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 62</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.3" lower_limit="11.5" upper_limit="21.1"/>
                    <measurement group_id="O2" value="18.1" lower_limit="13.3" upper_limit="22.9"/>
                    <measurement group_id="O3" value="15.2" lower_limit="10.2" upper_limit="20.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22</title>
        <description>The HAQ-DI score was defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled), where lower scores indicated less disability. Negative change from baseline indicates improvement (less disability).</description>
        <time_frame>Baseline, Weeks 2, 6, 14, 18, and 22</time_frame>
        <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Remicade-US Group</title>
            <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22</title>
          <description>The HAQ-DI score was defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled), where lower scores indicated less disability. Negative change from baseline indicates improvement (less disability).</description>
          <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="446"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="227"/>
                    <count group_id="O2" value="443"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.32" spread="0.55"/>
                    <measurement group_id="O2" value="1.34" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="222"/>
                    <count group_id="O2" value="435"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.21" spread="0.42"/>
                    <measurement group_id="O2" value="-0.28" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="223"/>
                    <count group_id="O2" value="438"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.33" spread="0.50"/>
                    <measurement group_id="O2" value="-0.37" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="215"/>
                    <count group_id="O2" value="412"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.35" spread="0.55"/>
                    <measurement group_id="O2" value="-0.35" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="213"/>
                    <count group_id="O2" value="404"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.41" spread="0.53"/>
                    <measurement group_id="O2" value="-0.43" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="216"/>
                    <count group_id="O2" value="399"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.35" spread="0.59"/>
                    <measurement group_id="O2" value="-0.39" spread="0.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</title>
        <description>The HAQ-DI score was defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled), where lower scores indicated less disability. Negative change from baseline indicates improvement (less disability).</description>
        <time_frame>Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
        <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants from stage 1 continued to receive IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</title>
          <description>The HAQ-DI score was defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled), where lower scores indicated less disability. Negative change from baseline indicates improvement (less disability).</description>
          <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="249"/>
                <count group_id="O3" value="197"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="195"/>
                    <count group_id="O3" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.40" spread="0.59"/>
                    <measurement group_id="O2" value="-0.44" spread="0.63"/>
                    <measurement group_id="O3" value="-0.40" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="187"/>
                    <count group_id="O3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.40" spread="0.57"/>
                    <measurement group_id="O2" value="-0.46" spread="0.62"/>
                    <measurement group_id="O3" value="-0.38" spread="0.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 34</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                    <count group_id="O2" value="180"/>
                    <count group_id="O3" value="182"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.47" spread="0.58"/>
                    <measurement group_id="O2" value="-0.50" spread="0.61"/>
                    <measurement group_id="O3" value="-0.44" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 38</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                    <count group_id="O2" value="181"/>
                    <count group_id="O3" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.43" spread="0.59"/>
                    <measurement group_id="O2" value="-0.46" spread="0.61"/>
                    <measurement group_id="O3" value="-0.41" spread="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 42</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="180"/>
                    <count group_id="O2" value="179"/>
                    <count group_id="O3" value="168"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.48" spread="0.56"/>
                    <measurement group_id="O2" value="-0.52" spread="0.65"/>
                    <measurement group_id="O3" value="-0.46" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 46</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="174"/>
                    <count group_id="O3" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.48" spread="0.60"/>
                    <measurement group_id="O2" value="-0.51" spread="0.67"/>
                    <measurement group_id="O3" value="-0.43" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="170"/>
                    <count group_id="O3" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.49" spread="0.58"/>
                    <measurement group_id="O2" value="-0.55" spread="0.64"/>
                    <measurement group_id="O3" value="-0.47" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 54</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="167"/>
                    <count group_id="O2" value="163"/>
                    <count group_id="O3" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.49" spread="0.58"/>
                    <measurement group_id="O2" value="-0.49" spread="0.64"/>
                    <measurement group_id="O3" value="-0.39" spread="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 58</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="165"/>
                    <count group_id="O2" value="160"/>
                    <count group_id="O3" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.49" spread="0.59"/>
                    <measurement group_id="O2" value="-0.52" spread="0.64"/>
                    <measurement group_id="O3" value="-0.44" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 62</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="162"/>
                    <count group_id="O2" value="160"/>
                    <count group_id="O3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.47" spread="0.59"/>
                    <measurement group_id="O2" value="-0.51" spread="0.64"/>
                    <measurement group_id="O3" value="-0.42" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22</title>
        <description>Disease activity was assessed using RAPID3, based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain, and participant global estimate.Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give total score=0-10, higher scores=greater difficulty.Pain and global estimate of health measured on Likert scale from '0'=no pain to '10'=pain as bad as it could be. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Total score range of RAPID3 score was 0=no difficulty; 30=greater difficultly, and disease activity categories were as follows: remission: 0-3, low: &gt;3.1 to 6, moderate: &gt;6.1-12, and high: &gt;12.1. Negative change from baseline indicates less disease activity.</description>
        <time_frame>Baseline, Weeks 2, 6, 14, 18, and 22</time_frame>
        <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Remicade-US Group</title>
            <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22</title>
          <description>Disease activity was assessed using RAPID3, based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain, and participant global estimate.Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give total score=0-10, higher scores=greater difficulty.Pain and global estimate of health measured on Likert scale from '0'=no pain to '10'=pain as bad as it could be. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Total score range of RAPID3 score was 0=no difficulty; 30=greater difficultly, and disease activity categories were as follows: remission: 0-3, low: &gt;3.1 to 6, moderate: &gt;6.1-12, and high: &gt;12.1. Negative change from baseline indicates less disease activity.</description>
          <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="446"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="224"/>
                    <count group_id="O2" value="438"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.03" spread="4.76"/>
                    <measurement group_id="O2" value="17.37" spread="4.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="219"/>
                    <count group_id="O2" value="432"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.99" spread="4.42"/>
                    <measurement group_id="O2" value="-3.79" spread="4.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="220"/>
                    <count group_id="O2" value="430"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.15" spread="5.14"/>
                    <measurement group_id="O2" value="-5.05" spread="5.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="213"/>
                    <count group_id="O2" value="400"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.04" spread="5.80"/>
                    <measurement group_id="O2" value="-4.91" spread="6.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="213"/>
                    <count group_id="O2" value="402"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.99" spread="5.96"/>
                    <measurement group_id="O2" value="-5.73" spread="6.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.71" spread="6.42"/>
                    <measurement group_id="O2" value="-5.41" spread="6.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</title>
        <description>Disease activity was assessed using RAPID3, based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain and participant global estimate. Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give total score=0-10, higher scores=greater difficulty. Pain and global estimate of health measured on Likert scale from '0'=no pain to '10'=pain as bad as it could be. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Total score range of RAPID3 score was 0=no difficulty-30=greater difficultly, and disease activity categories were as follows: remission: 0-3, low: &gt;3.1 to 6, moderate: &gt;6.1-12, and high: &gt;12.1. Negative change from baseline indicates less disease activity.</description>
        <time_frame>Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</time_frame>
        <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline RAPID3 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants from stage 1 continued to receive IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62</title>
          <description>Disease activity was assessed using RAPID3, based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain and participant global estimate. Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give total score=0-10, higher scores=greater difficulty. Pain and global estimate of health measured on Likert scale from '0'=no pain to '10'=pain as bad as it could be. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Total score range of RAPID3 score was 0=no difficulty-30=greater difficultly, and disease activity categories were as follows: remission: 0-3, low: &gt;3.1 to 6, moderate: &gt;6.1-12, and high: &gt;12.1. Negative change from baseline indicates less disease activity.</description>
          <population>The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline RAPID3 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="249"/>
                <count group_id="O3" value="197"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="209"/>
                    <count group_id="O2" value="183"/>
                    <count group_id="O3" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.81" spread="6.23"/>
                    <measurement group_id="O2" value="-6.34" spread="6.55"/>
                    <measurement group_id="O3" value="-5.64" spread="6.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                    <count group_id="O2" value="181"/>
                    <count group_id="O3" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.43" spread="6.38"/>
                    <measurement group_id="O2" value="-6.41" spread="6.81"/>
                    <measurement group_id="O3" value="-5.26" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 34</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="194"/>
                    <count group_id="O2" value="176"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.24" spread="6.06"/>
                    <measurement group_id="O2" value="-7.39" spread="6.51"/>
                    <measurement group_id="O3" value="-6.22" spread="6.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 38</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="183"/>
                    <count group_id="O2" value="177"/>
                    <count group_id="O3" value="170"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.91" spread="6.25"/>
                    <measurement group_id="O2" value="-6.59" spread="7.14"/>
                    <measurement group_id="O3" value="-5.86" spread="6.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 42</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="175"/>
                    <count group_id="O2" value="173"/>
                    <count group_id="O3" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.69" spread="6.10"/>
                    <measurement group_id="O2" value="-7.40" spread="6.82"/>
                    <measurement group_id="O3" value="-6.49" spread="6.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 46</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="170"/>
                    <count group_id="O3" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.34" spread="6.35"/>
                    <measurement group_id="O2" value="-7.11" spread="6.99"/>
                    <measurement group_id="O3" value="-5.79" spread="6.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="167"/>
                    <count group_id="O2" value="162"/>
                    <count group_id="O3" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.85" spread="6.36"/>
                    <measurement group_id="O2" value="-7.94" spread="7.22"/>
                    <measurement group_id="O3" value="-6.48" spread="6.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 54</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                    <count group_id="O2" value="160"/>
                    <count group_id="O3" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.63" spread="6.33"/>
                    <measurement group_id="O2" value="-7.11" spread="7.27"/>
                    <measurement group_id="O3" value="-5.38" spread="6.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 58</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="162"/>
                    <count group_id="O2" value="156"/>
                    <count group_id="O3" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.84" spread="6.54"/>
                    <measurement group_id="O2" value="-7.83" spread="7.05"/>
                    <measurement group_id="O3" value="-6.41" spread="6.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 62</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="204"/>
                    <count group_id="O2" value="183"/>
                    <count group_id="O3" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.35" spread="6.83"/>
                    <measurement group_id="O2" value="-6.28" spread="7.46"/>
                    <measurement group_id="O3" value="-5.74" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 14 and 22</title>
        <description>SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental heallth) with a Subscale Total score for each scaled from 0 (minimum) to 100 (maximum) with a Total Overall score on a 0-800 scale, with higher scores indicating better health. where higher score indicates highest level of functioning. These 8 aspects can also be summarized as Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. Change from baseline in overall total score for SF-36 was reported in this outcome measure.</description>
        <time_frame>Baseline, Weeks 14 and 22</time_frame>
        <population>The ITT population included all participants who were randomized. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Remicade-US Group</title>
            <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 14 and 22</title>
          <description>SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental heallth) with a Subscale Total score for each scaled from 0 (minimum) to 100 (maximum) with a Total Overall score on a 0-800 scale, with higher scores indicating better health. where higher score indicates highest level of functioning. These 8 aspects can also be summarized as Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. Change from baseline in overall total score for SF-36 was reported in this outcome measure.</description>
          <population>The ITT population included all participants who were randomized. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="446"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="223"/>
                    <count group_id="O2" value="437"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="360.46" spread="116.64"/>
                    <measurement group_id="O2" value="358.20" spread="126.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="399"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.90" spread="124.86"/>
                    <measurement group_id="O2" value="77.59" spread="124.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="211"/>
                    <count group_id="O2" value="390"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.02" spread="122.36"/>
                    <measurement group_id="O2" value="82.94" spread="129.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 38 and 62</title>
        <description>SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental heallth) with a Subscale Total score for each scaled from 0 (minimum) to 100 (maximum) with a Total Overall score on a 0-800 scale, with higher scores indicating better health. where higher score indicates highest level of functioning. Total score for each subscale scaled from 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 8 aspects can also be summarized as PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.</description>
        <time_frame>Baseline, Weeks 38 and 62</time_frame>
        <population>The ITT population included all participants who were randomized. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants from stage 1 continued to receive IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 38 and 62</title>
          <description>SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental heallth) with a Subscale Total score for each scaled from 0 (minimum) to 100 (maximum) with a Total Overall score on a 0-800 scale, with higher scores indicating better health. where higher score indicates highest level of functioning. Total score for each subscale scaled from 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 8 aspects can also be summarized as PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.</description>
          <population>The ITT population included all participants who were randomized. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="249"/>
                <count group_id="O3" value="197"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 38</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="182"/>
                    <count group_id="O2" value="176"/>
                    <count group_id="O3" value="169"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.10" spread="127.26"/>
                    <measurement group_id="O2" value="96.93" spread="136.80"/>
                    <measurement group_id="O3" value="87.61" spread="129.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 62</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="213"/>
                    <count group_id="O3" value="182"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.56" spread="143.91"/>
                    <measurement group_id="O2" value="95.24" spread="148.23"/>
                    <measurement group_id="O3" value="87.51" spread="122.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22</title>
        <description>SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. A Subscale Total score for each scaled from 0 (minimum) to 100 (maximum). Total score for each subscale scaled from 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 2 subscale aspects can also be summarized as PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.</description>
        <time_frame>Baseline, Weeks 14 and 22</time_frame>
        <population>The ITT population included all participants who were randomized. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Remicade-US Group</title>
            <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22</title>
          <description>SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. A Subscale Total score for each scaled from 0 (minimum) to 100 (maximum). Total score for each subscale scaled from 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 2 subscale aspects can also be summarized as PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.</description>
          <population>The ITT population included all participants who were randomized. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="446"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Physical Component)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="223"/>
                    <count group_id="O2" value="437"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.22" spread="7.72"/>
                    <measurement group_id="O2" value="30.53" spread="7.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 14 (Physical Component)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="399"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.42" spread="7.86"/>
                    <measurement group_id="O2" value="5.64" spread="8.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 22 (Physical Component)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="211"/>
                    <count group_id="O2" value="390"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.61" spread="8.36"/>
                    <measurement group_id="O2" value="6.03" spread="8.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (Mental Component)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="223"/>
                    <count group_id="O2" value="437"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.59" spread="11.57"/>
                    <measurement group_id="O2" value="43.02" spread="12.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 14 (Mental Component)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="399"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.05" spread="10.36"/>
                    <measurement group_id="O2" value="2.56" spread="10.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 22 (Mental Component)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="211"/>
                    <count group_id="O2" value="390"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.05" spread="9.48"/>
                    <measurement group_id="O2" value="2.71" spread="10.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62</title>
        <description>SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. A Subscale Total score for each scaled from 0 (minimum) to 100 (maximum). Total score for each subscale scaled from 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 2 subscale aspects can also be summarized as PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.</description>
        <time_frame>Baseline, Weeks 38 and 62</time_frame>
        <population>The ITT population included all participants who were randomized. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants from stage 1 continued to receive IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62</title>
          <description>SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. A Subscale Total score for each scaled from 0 (minimum) to 100 (maximum). Total score for each subscale scaled from 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 2 subscale aspects can also be summarized as PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.</description>
          <population>The ITT population included all participants who were randomized. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="249"/>
                <count group_id="O3" value="197"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 38 (Physical Component)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="182"/>
                    <count group_id="O2" value="176"/>
                    <count group_id="O3" value="169"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.94" spread="8.37"/>
                    <measurement group_id="O2" value="6.86" spread="9.31"/>
                    <measurement group_id="O3" value="6.22" spread="9.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 62 (Physical Component)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="213"/>
                    <count group_id="O3" value="182"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.14" spread="8.79"/>
                    <measurement group_id="O2" value="6.23" spread="9.78"/>
                    <measurement group_id="O3" value="6.11" spread="8.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 38 (Mental Component)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="182"/>
                    <count group_id="O2" value="176"/>
                    <count group_id="O3" value="169"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.09" spread="10.55"/>
                    <measurement group_id="O2" value="3.38" spread="11.32"/>
                    <measurement group_id="O3" value="3.10" spread="10.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 62 (Mental Component)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="213"/>
                    <count group_id="O3" value="182"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.45" spread="10.92"/>
                    <measurement group_id="O2" value="3.93" spread="11.59"/>
                    <measurement group_id="O3" value="3.16" spread="10.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2 and 3: Minimum Observed Serum Concentration (Cmin) of NI-071 and Remicade US</title>
        <description>Drug concentrations in blood were evaluated from week 46 to week 54 after the initial administration date.&#xD;
Blood sampling was performed before administration of week 46, at the end of the infusion, and at 4 hours, 24 hours, 7 days (week 47), 14 days (week 48), 28 days (week 50), and 56 days (before administration of week 54). Cmin was define as the lowest drug concentration among all blood sampling points for an individual patient.</description>
        <time_frame>Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose</time_frame>
        <population>PK population included all participants in the FAS in Stage 1 who have valid PK assessments through Stage 2. The FAS included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Stage 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants from stage 1 continued to receive IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and 3: Minimum Observed Serum Concentration (Cmin) of NI-071 and Remicade US</title>
          <description>Drug concentrations in blood were evaluated from week 46 to week 54 after the initial administration date.&#xD;
Blood sampling was performed before administration of week 46, at the end of the infusion, and at 4 hours, 24 hours, 7 days (week 47), 14 days (week 48), 28 days (week 50), and 56 days (before administration of week 54). Cmin was define as the lowest drug concentration among all blood sampling points for an individual patient.</description>
          <population>PK population included all participants in the FAS in Stage 1 who have valid PK assessments through Stage 2. The FAS included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Stage 1.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="155"/>
                <count group_id="O3" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="839.1" spread="1322.2"/>
                    <measurement group_id="O2" value="754.1" spread="1380.0"/>
                    <measurement group_id="O3" value="762.6" spread="1207.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2 and 3: Time to Reach the Maximum Serum Concentration (Tmax) of NI-071 and Remicade US</title>
        <time_frame>Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose</time_frame>
        <population>PK population included all participants in the FAS in Stage 1 who have valid PK assessments through Stage 2. The FAS included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Stage 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants from stage 1 continued to receive IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and 3: Time to Reach the Maximum Serum Concentration (Tmax) of NI-071 and Remicade US</title>
          <population>PK population included all participants in the FAS in Stage 1 who have valid PK assessments through Stage 2. The FAS included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Stage 1.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="155"/>
                <count group_id="O3" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.37" spread="243.64"/>
                    <measurement group_id="O2" value="41.57" spread="217.28"/>
                    <measurement group_id="O3" value="32.98" spread="191.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs</title>
        <description>An adverse event (AE) was defined as any untoward medical condition that occurs in participants while participating in a clinical study and does not necessarily have a causal relationship with the use of the study treatment. A TEAE was defined as an adverse event with a start date on or after the first dose of Investigational product (IP), or a start date before the date of the first dose of IP but increased in severity on or after the date of the first dose of IP. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Number of participants with TEAEs and Serious TEAEs were reported.</description>
        <time_frame>Baseline up to Week 62</time_frame>
        <population>The safety population included participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Stages 1, 2 and 3: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 milligrams/kilograms (mg/kg) at Weeks 0, 2, 6, 14 during stage 1 and at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Remicade-US Group</title>
            <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1 and were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O4">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1 and were re-randomized during stage 2 received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs</title>
          <description>An adverse event (AE) was defined as any untoward medical condition that occurs in participants while participating in a clinical study and does not necessarily have a causal relationship with the use of the study treatment. A TEAE was defined as an adverse event with a start date on or after the first dose of Investigational product (IP), or a start date before the date of the first dose of IP but increased in severity on or after the date of the first dose of IP. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Number of participants with TEAEs and Serious TEAEs were reported.</description>
          <population>The safety population included participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="451"/>
                <count group_id="O3" value="254"/>
                <count group_id="O4" value="197"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157"/>
                    <measurement group_id="O2" value="330"/>
                    <measurement group_id="O3" value="181"/>
                    <measurement group_id="O4" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with Serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="41"/>
                    <measurement group_id="O3" value="28"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With TEAEs of Special Interest</title>
        <description>A TEAE was defined as an adverse event with a start date on or after the first dose of IP or a start date before the date of the first dose of IP but increased in severity on or after the date of the first dose of IP.</description>
        <time_frame>Baseline up to Week 62</time_frame>
        <population>The safety population included participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1, Stage 2, and Stage 3: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1 and at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Remicade-US Group</title>
            <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O4">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TEAEs of Special Interest</title>
          <description>A TEAE was defined as an adverse event with a start date on or after the first dose of IP or a start date before the date of the first dose of IP but increased in severity on or after the date of the first dose of IP.</description>
          <population>The safety population included participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="451"/>
                <count group_id="O3" value="254"/>
                <count group_id="O4" value="197"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="68"/>
                    <measurement group_id="O3" value="43"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)</title>
        <description>Number of Participants With Positive Serum ADA are reported.</description>
        <time_frame>Baseline, Weeks 2, 6, 14, and 22</time_frame>
        <population>The safety population included participants who received at least 1 dose of study drug. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Remicade-US Group</title>
            <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)</title>
          <description>Number of Participants With Positive Serum ADA are reported.</description>
          <population>The safety population included participants who received at least 1 dose of study drug. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="451"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="222"/>
                    <count group_id="O2" value="447"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="226"/>
                    <count group_id="O2" value="439"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="223"/>
                    <count group_id="O2" value="437"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="215"/>
                    <count group_id="O2" value="412"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150"/>
                    <measurement group_id="O2" value="303"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="213"/>
                    <count group_id="O2" value="396"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="187"/>
                    <measurement group_id="O2" value="337"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)</title>
        <description>Number of Participants With Positive Serum Anti-drug Antibodies (ADA) are reported.</description>
        <time_frame>At Weeks 30, 38, 46, 54, and 62</time_frame>
        <population>The safety population included participants who received at least 1 dose of study drug. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants from stage 1 continued to receive IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)</title>
          <description>Number of Participants With Positive Serum Anti-drug Antibodies (ADA) are reported.</description>
          <population>The safety population included participants who received at least 1 dose of study drug. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="254"/>
                <count group_id="O3" value="197"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="185"/>
                    <count group_id="O3" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185"/>
                    <measurement group_id="O2" value="166"/>
                    <measurement group_id="O3" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 38</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="183"/>
                    <count group_id="O2" value="181"/>
                    <count group_id="O3" value="169"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="167"/>
                    <measurement group_id="O2" value="162"/>
                    <measurement group_id="O3" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 46</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="153"/>
                    <measurement group_id="O2" value="150"/>
                    <measurement group_id="O3" value="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 54</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="162"/>
                    <count group_id="O2" value="163"/>
                    <count group_id="O3" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147"/>
                    <measurement group_id="O2" value="145"/>
                    <measurement group_id="O3" value="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 62</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="208"/>
                    <count group_id="O2" value="217"/>
                    <count group_id="O3" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="187"/>
                    <measurement group_id="O2" value="191"/>
                    <measurement group_id="O3" value="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Number of Participants With Positive Serum Neutralizing Antibodies</title>
        <description>Number of Participants with Positive Serum neutralizing Antibodies were reported.</description>
        <time_frame>Baseline, Weeks 2, 6, 14, and 22</time_frame>
        <population>The safety population included participants who received at least 1 dose of study drug. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 1: NI-071 Group</title>
            <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
          <group group_id="O2">
            <title>Stage 1: Remicade-US Group</title>
            <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Number of Participants With Positive Serum Neutralizing Antibodies</title>
          <description>Number of Participants with Positive Serum neutralizing Antibodies were reported.</description>
          <population>The safety population included participants who received at least 1 dose of study drug. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="451"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="153"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="187"/>
                    <count group_id="O2" value="337"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies</title>
        <description>Number of Participants with Positive Serum neutralizing Antibodies were reported.</description>
        <time_frame>At Weeks 30, 38, 46, 54, and 62</time_frame>
        <population>The safety population included participants who received at least 1 dose of study drug. Here, &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Stage 2 and Stage 3: NI-071 Group</title>
            <description>Participants from stage 1 continued to receive IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O2">
            <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
          </group>
          <group group_id="O3">
            <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
            <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies</title>
          <description>Number of Participants with Positive Serum neutralizing Antibodies were reported.</description>
          <population>The safety population included participants who received at least 1 dose of study drug. Here, &quot;Number Analyzed&quot; signifies those participants who were evaluable at specific time point. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="254"/>
                <count group_id="O3" value="197"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                    <count group_id="O2" value="166"/>
                    <count group_id="O3" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                    <measurement group_id="O2" value="90"/>
                    <measurement group_id="O3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 38</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="167"/>
                    <count group_id="O2" value="162"/>
                    <count group_id="O3" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="96"/>
                    <measurement group_id="O3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 46</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="153"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="141"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                    <measurement group_id="O2" value="87"/>
                    <measurement group_id="O3" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 54</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="145"/>
                    <count group_id="O3" value="141"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="87"/>
                    <measurement group_id="O3" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 62</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="187"/>
                    <count group_id="O2" value="191"/>
                    <count group_id="O3" value="165"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="124"/>
                    <measurement group_id="O3" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to Week 62</time_frame>
      <desc>The safety population included participants who received at least 1 dose of study drug at Baseline. The analyses were calculated by the number of All-Cause Mortality/safety population, the number of SAE's/safety population and the number of oher AE's/safety population. The patient number of safety population is the number of patients evaluated at baseline, which is different from the number of patients who started to Stage 2 or 3.</desc>
      <group_list>
        <group group_id="E1">
          <title>Stage 1, 2 and 3: NI-071 Group</title>
          <description>Participants received IV infusion of NI-071 at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1 and at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).</description>
        </group>
        <group group_id="E2">
          <title>Stage 1: Remicade-US Group</title>
          <description>Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.</description>
        </group>
        <group group_id="E3">
          <title>Stage 2 and Stage 3: Remicade US to Remicade-US Group</title>
          <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).</description>
        </group>
        <group group_id="E4">
          <title>Stage 2 and Stage 3: Remicade US to Switch Group</title>
          <description>Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="28" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Enterocolitis haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Rectal prolapse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Extradural abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>H1N1 influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Joint contracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Intervertebral disc disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Haemangioma of bone</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Lung neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Meningioma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Papillary thyroid cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Renal cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of Lung</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Rheumatoid lung</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hysterectomy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Medical device removal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (19.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="96" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="174" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="80" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="94" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="21" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="20" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="227"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="451"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Hiroshi Anekawa</name_or_title>
      <organization>Nichi-Iko Pharmaceutical Co., Ltd</organization>
      <phone>+81-3-6262-1564</phone>
      <email>hiroshi-anekawa@nichiiko.co.jp</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02990806
org study id: NI071F2
nct id: NCT02990806
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study was to demonstrate similarity of NI-071 (proposed biosimilar to
      infliximab) to US REMICADE® (reference product) in terms of safety and efficacy in
      participants with rheumatoid arthritis (RA) not adequately responding to methotrexate (MTX).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR20-CRP) Response Rate at Week 22
time frame: At Week 22
description: ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity visual analog scale (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS) (0= no symptoms;100=severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) Health Assessment Questionnaire-Disability Index (HAQ-DI), total score ranging from 0-3 with lower scores meaning less disability, e) CRP.
measure: Stage 2 and 3: Area Under the Serum Concentration-time Curve Interval (AUCtau) of NI-071 and Remicade US
time frame: Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose
description: AUCtau of NI-071 and Remicade US in stage 2 and 3 was reported. As this was an interchangeability study, the NI-071 and Remicade only were the comparators and then switch study showed same measurement in relationship to the non-switched participants. Hence, combined data was assessed and collected in participants from Remicade US to Switch Group.
measure: Stage 2 and 3: Maximum Observed Serum Concentration (Cmax) of NI-071 and Remicade US
time frame: Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose
description: Cmax of NI-071 and Remicade US was reported. As this was an interchangeability study, the NI-071 and Remicade only were the comparators and then switch study showed same measurement in relationship to the non-switched participants. Hence, combined data was assessed and collected in participants from Remicade US to Switch Group.
measure: Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22
time frame: Baseline, Weeks 2, 6, 14, 18, and 22
description: The DAS28-CRP was a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints [assessed on 2-point scale (0=absent; 1=present]), swollen joint count (out of 28 evaluated joints[assessed on 2-point scale (0=absent; 1=present)]), Participant's global assessment of disease activity (assessed on 0-100 mm VAS; where higher scores denotes severe symptoms), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Total Scores on the DAS28-CRP range from 0 to approximately 10 (0=very good, no symptoms; 10=very poor, severe symptoms), where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.
measure: Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62
time frame: Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62
description: The DAS28-CRP was a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints [assessed on 2-point scale (0=absent; 1=present]), swollen joint count (out of 28 evaluated joints[assessed on 2-point scale (0=absent; 1=present)]), Participant's global assessment of disease activity (assessed on 0-100 mm VAS; where higher scores denotes severe symptoms), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Total Scores on the DAS28-CRP range from 0 to approximately 10 (0=very good, no symptoms; 10=very poor, severe symptoms), where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.
measure: Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22
time frame: Baseline, Weeks 2, 6, 14, 18, and 22
description: DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (millimeters per hour) and GH recorded on 100mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). DAS28 (ESR) was calculated as 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.70*ln(ESR [mm/hour] + 0.014*GH [mm]; where, TJC28 = number of painful joints out of 28 joints, SJC28 = number of swollen joints out of 28 joints, GH = score of the participant global assessment of disease activity, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. A negative change from baseline indicates improvement in disease activity.
measure: Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62
time frame: Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62
description: DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (millimeters per hour) and Patient Global Assessment (PtGA) recorded on 100mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). DAS28 (ESR) was calculated as 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.70*ln(ESR [mm/hour] + 0.014*GH [mm]; where, TJC28 = number of painful joints out of 28 joints, SJC28 = number of swollen joints out of 28 joints, GH = score of the participant global assessment of disease activity, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. A negative change from baseline indicates improvement in disease activity.
measure: Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate
time frame: At Weeks 2, 6, 14, 18, and 22
description: ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) CRP.
measure: Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate
time frame: At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62
description: ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) CRP.
measure: Stage 1: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)
time frame: At Weeks 2, 6, 14, 18, and 22
description: ACR20-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) erythrocyte sedimentation rate (ESR).
measure: Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)
time frame: At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62
description: ACR20-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) (ESR.
measure: Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate
time frame: At Weeks 2, 6, 14, 18, and 22
description: ACR50 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.
measure: Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate
time frame: At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62
description: ACR50 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.
measure: Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR
time frame: At Weeks 2, 6, 14, 18, and 22
description: ACR50-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.
measure: Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR
time frame: At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62
description: ACR50-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.
measure: Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate
time frame: At Weeks 2, 6, 14, 18, and 22
description: ACR70 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.
measure: Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate
time frame: At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62
description: ACR70 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.
measure: Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR
time frame: At Weeks 2, 6, 14, 18, 22
description: ACR70-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.
measure: Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR
time frame: At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62
description: ACR70-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.
measure: Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22
time frame: Baseline, Weeks 2, 6, 14, 18, and 22
description: The HAQ-DI score was defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled), where lower scores indicated less disability. Negative change from baseline indicates improvement (less disability).
measure: Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62
time frame: Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62
description: The HAQ-DI score was defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled), where lower scores indicated less disability. Negative change from baseline indicates improvement (less disability).
measure: Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22
time frame: Baseline, Weeks 2, 6, 14, 18, and 22
description: Disease activity was assessed using RAPID3, based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain, and participant global estimate.Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give total score=0-10, higher scores=greater difficulty.Pain and global estimate of health measured on Likert scale from '0'=no pain to '10'=pain as bad as it could be. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Total score range of RAPID3 score was 0=no difficulty; 30=greater difficultly, and disease activity categories were as follows: remission: 0-3, low: >3.1 to 6, moderate: >6.1-12, and high: >12.1. Negative change from baseline indicates less disease activity.
measure: Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62
time frame: Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62
description: Disease activity was assessed using RAPID3, based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain and participant global estimate. Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give total score=0-10, higher scores=greater difficulty. Pain and global estimate of health measured on Likert scale from '0'=no pain to '10'=pain as bad as it could be. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Total score range of RAPID3 score was 0=no difficulty-30=greater difficultly, and disease activity categories were as follows: remission: 0-3, low: >3.1 to 6, moderate: >6.1-12, and high: >12.1. Negative change from baseline indicates less disease activity.
measure: Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 14 and 22
time frame: Baseline, Weeks 14 and 22
description: SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental heallth) with a Subscale Total score for each scaled from 0 (minimum) to 100 (maximum) with a Total Overall score on a 0-800 scale, with higher scores indicating better health. where higher score indicates highest level of functioning. These 8 aspects can also be summarized as Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. Change from baseline in overall total score for SF-36 was reported in this outcome measure.
measure: Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 38 and 62
time frame: Baseline, Weeks 38 and 62
description: SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental heallth) with a Subscale Total score for each scaled from 0 (minimum) to 100 (maximum) with a Total Overall score on a 0-800 scale, with higher scores indicating better health. where higher score indicates highest level of functioning. Total score for each subscale scaled from 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 8 aspects can also be summarized as PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
measure: Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22
time frame: Baseline, Weeks 14 and 22
description: SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. A Subscale Total score for each scaled from 0 (minimum) to 100 (maximum). Total score for each subscale scaled from 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 2 subscale aspects can also be summarized as PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
measure: Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62
time frame: Baseline, Weeks 38 and 62
description: SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. A Subscale Total score for each scaled from 0 (minimum) to 100 (maximum). Total score for each subscale scaled from 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 2 subscale aspects can also be summarized as PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
measure: Stage 2 and 3: Minimum Observed Serum Concentration (Cmin) of NI-071 and Remicade US
time frame: Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose
description: Drug concentrations in blood were evaluated from week 46 to week 54 after the initial administration date.
Blood sampling was performed before administration of week 46, at the end of the infusion, and at 4 hours, 24 hours, 7 days (week 47), 14 days (week 48), 28 days (week 50), and 56 days (before administration of week 54). Cmin was define as the lowest drug concentration among all blood sampling points for an individual patient.
measure: Stage 2 and 3: Time to Reach the Maximum Serum Concentration (Tmax) of NI-071 and Remicade US
time frame: Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
time frame: Baseline up to Week 62
description: An adverse event (AE) was defined as any untoward medical condition that occurs in participants while participating in a clinical study and does not necessarily have a causal relationship with the use of the study treatment. A TEAE was defined as an adverse event with a start date on or after the first dose of Investigational product (IP), or a start date before the date of the first dose of IP but increased in severity on or after the date of the first dose of IP. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Number of participants with TEAEs and Serious TEAEs were reported.
measure: Number of Participants With TEAEs of Special Interest
time frame: Baseline up to Week 62
description: A TEAE was defined as an adverse event with a start date on or after the first dose of IP or a start date before the date of the first dose of IP but increased in severity on or after the date of the first dose of IP.
measure: Stage 1: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)
time frame: Baseline, Weeks 2, 6, 14, and 22
description: Number of Participants With Positive Serum ADA are reported.
measure: Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)
time frame: At Weeks 30, 38, 46, 54, and 62
description: Number of Participants With Positive Serum Anti-drug Antibodies (ADA) are reported.
measure: Stage 1: Number of Participants With Positive Serum Neutralizing Antibodies
time frame: Baseline, Weeks 2, 6, 14, and 22
description: Number of Participants with Positive Serum neutralizing Antibodies were reported.
measure: Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies
time frame: At Weeks 30, 38, 46, 54, and 62
description: Number of Participants with Positive Serum neutralizing Antibodies were reported.
arm group label: Stages 1, 2 and 3: NI-071 Group
arm group type: Experimental
description: Participants received intravenous (IV) infusion of NI-071 at a dose of 3 milligrams/kilograms (mg/kg) at Weeks 0, 2, 6, 14 during stage 1 and at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).
arm group label: Stage 1: Remicade-US Group
arm group type: Experimental
description: Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.
arm group label: Stage 2 and Stage 3: Remicade US to Remicade-US Group
arm group type: Experimental
description: Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).
arm group label: Stage 2 and Stage 3: Remicade US to Switch Group
arm group type: Experimental
description: Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).
intervention type: Drug
intervention name: NI-071
description: IV infusion.
arm group label: Stage 2 and Stage 3: Remicade US to Switch Group
arm group label: Stages 1, 2 and 3: NI-071 Group
intervention type: Drug
intervention name: Remicade
description: IV infusion.
arm group label: Stage 1: Remicade-US Group
arm group label: Stage 2 and Stage 3: Remicade US to Remicade-US Group
arm group label: Stage 2 and Stage 3: Remicade US to Switch Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
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country: Czechia
country: Poland
country: Puerto Rico
country: Russian Federation
country: Spain
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Infliximab
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 