xml: <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/NCT06028438</url>
    </required_header>
    <id_info>
      <org_study_id>CR109343</org_study_id>
      <secondary_id>2023-504045-31-00</secondary_id>
      <secondary_id>80202135ARA2002</secondary_id>
      <nct_id>NCT06028438</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis</brief_title>
    <acronym>DAISY</acronym>
    <official_title>A Phase 2a Multicenter, Randomized, Double Blind, Parallel, Proof of Concept Study Evaluating the Efficacy and Safety of Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis Despite Prior Treatment With Advanced Therapies (bDMARD or tsDMARD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Janssen Research &amp; Development, LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Janssen Research &amp; Development, LLC</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 is to evaluate the efficacy of combination therapy with nipocalimab&#xD;
        and certolizumab compared to certolizumab monotherapy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 3, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12</measure>
      <time_frame>Baseline, Week 12</time_frame>
      <description>Change from baseline in DAS28-CRP score at Week 12 will be reported. DAS28-CRP is combined index used to assess rheumatoid arthritis (RA) disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), CRP, and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP)1, MCP2, MCP3, MCP4, MCP5, proximal interphalangeal (PIP)1, PIP2, PIP3, PIP4, PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. Lower scores indicate better disease control and higher scores indicate worse disease control.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 12</measure>
      <time_frame>At Week 12</time_frame>
      <description>Percentage of participants achieving ACR 20 response at Week 12 will be reported. ACR 20 response is defined as greater than or equal to (&gt;=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and &gt;= 20% improvement from baseline in 3 of 5 assessments: patient's global assessment of disease activity (arthritis, visual analog scale [VAS]; 0-100 mm, 0=excellent and 100=poor), patient's assessment of pain by VAS (VAS; 0-100 millimeter [mm], 0=no pain and 100=worst possible pain), patient's assessment of physical function measured by health assessment questionnaire-disability index (HAQ-DI), defined as a 20-question instrument assessing 8 functional areas, range: 0-3, 0=no difficulty, 3=inability to perform a task in that area, physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity, and 100=extremely active arthritis), and CRP.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants Achieving ACR 50 Response at Week 12</measure>
      <time_frame>At Week 12</time_frame>
      <description>Percentage of participants achieving ACR 50 response at Week 12 will be reported. ACR 50 response is defined as &gt;= 50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and &gt;= 50% improvement from baseline in 3 of 5 assessments: patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), patient's assessment of pain by visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas, range: 0-3, 0=no difficulty, 3=inability to perform a task in that area, physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and CRP.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants Achieving ACR 70 Response at Week 12</measure>
      <time_frame>At Week 12</time_frame>
      <description>Percentage of participants achieving ACR 70 response at Week 12 will be reported. ACR70 response is defined as &gt;= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and &gt;=70% improvement from baseline in 3 of 5 assessments: patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), patient's assessment of pain by visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas), range: 0-3, 0=no difficulty, 3=inability to perform a task in that area, physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and CRP.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants Achieving ACR90 Response at Week 12</measure>
      <time_frame>At Week 12</time_frame>
      <description>Percentage of participants achieving ACR 90 response at Week 12 will be reported. ACR 90 response is defined as &gt;= 90% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and &gt;= 90% improvement from baseline in 3 of 5 assessments: patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), patient's assessment of pain by visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas), range: 0-3, 0=no difficulty, 3=inability to perform a task in that area, physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and CRP.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants Achieving DAS28-CRP Remission at Week 12</measure>
      <time_frame>At Week 12</time_frame>
      <description>Percentage of participants achieving DAS28-CRP level for remission at Week 12 will be reported. DAS28-CRP remission is defined as DAS28-CRP value less than (&lt;) 2.6 at the analysis visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants Achieving DAS28-CRP Low Disease Activity (LDA) at Week 12</measure>
      <time_frame>At Week 12</time_frame>
      <description>Percentage of participants achieving DAS28-CRP level for LDA at Week 12 will be reported. DAS28 LDA is defined as a DAS28 value of less than or equal to (&lt;=) 3.2 at the analysis visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12</measure>
      <time_frame>Baseline, Week 12</time_frame>
      <description>Change from baseline in HAQ-DI score at Week 12 will be reported. The functional status of the participant will be assessed using the HAQ-DI. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Lower scores are indicative of better functioning.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in Clinical Disease Activity Index Score (CDAI) at Week 12</measure>
      <time_frame>Baseline, Week 12</time_frame>
      <description>Change from baseline in CDAI score to Week 12 will be reported. The CDAI score is a derived combined index used to assess rheumatoid arthritis (RA) disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient's global assessment of disease activity (arthritis, VAS; 0-10 centimeter (cm), 0=excellent and 10= poor), and physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis). CDAI total score ranges from 0 to 76.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</measure>
      <time_frame>Up to Week 30</time_frame>
      <description>An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical or biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)</measure>
      <time_frame>Up to Week 30</time_frame>
      <description>SAE is any untoward medical occurrence that at any dose results in death, is life-threatening (The participant was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it was more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important. Treatment-emergent SAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With TEAEs Leading to Discontinuation of Study Intervention</measure>
      <time_frame>Up to Week 30</time_frame>
      <description>Number of participants with TEAEs leading to discontinuation of study intervention will be reported. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Adverse Events of Special interests (AESIs)</measure>
      <time_frame>Up to Week 30</time_frame>
      <description>Number of participants with AESIs will be reported. TEAEs associated with the following situations are considered to be AESIs: Infections that are severe or require intravenous (IV) anti-infective or operative or invasive intervention, clinically significant opportunistic infection (for example, active TB, invasive fungal infections), hypoalbuminemia with albumin level &lt;20 gram per liter (g/L), and any newly identified malignancies.&#xD;
  An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">85</enrollment>
    <condition>Arthritis, Rheumatoid</condition>
    <arm_group>
      <arm_group_label>Certolizumab + Placebo</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive placebo intravenously (IV) and certolizumab dose 1 subcutaneously at Week 0, 2, and 4 followed by placebo IV and certolizumab dose 2 subcutaneously at Weeks 6 to 22.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Certolizumab + Nipocalimab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive nipocalimab IV and certolizumab dose 1 subcutaneously at Week 0, 2, and 4 followed by nipocalimab IV and certolizumab dose 2 subcutaneously at Weeks 6 to 22.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo will be administered intravenously.</description>
      <arm_group_label>Certolizumab + Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Nipocalimab</intervention_name>
      <description>Nipocalimab will be administered intravenously.</description>
      <arm_group_label>Certolizumab + Nipocalimab</arm_group_label>
      <other_name>JNJ-80202135</other_name>
      <other_name>M281</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Certolizumab</intervention_name>
      <description>Certolizumab will be administered subcutaneously.</description>
      <arm_group_label>Certolizumab + Nipocalimab</arm_group_label>
      <arm_group_label>Certolizumab + Placebo</arm_group_label>
      <other_name>Cimzia</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of rheumatoid arthritis (RA) and meeting the 2010 American college of&#xD;
               rheumatology (ACR) or European League Against Rheumatism (EULAR) criteria for RA for&#xD;
               at least 3 months before screening&#xD;
  &#xD;
            -  Has moderate to severe active RA as defined by persistent disease activity with at&#xD;
               least 6 of 66 swollen joints and 6 of 68 tender joints at the time of screening and at&#xD;
               baseline&#xD;
  &#xD;
            -  Is positive for anti-citrullinated protein antibodies (ACPA) or rheumatoid factor (RF)&#xD;
               by the central laboratory at the time of screening&#xD;
  &#xD;
            -  Has C-reactive protein (CRP) greater than or equal to (&gt;=) 0.3 milligram per deciliter&#xD;
               (mg/dL) by the central laboratory at the time of screening&#xD;
  &#xD;
            -  If has received prior biological disease-modifying antirheumatic drugs (bDMARDs) (or&#xD;
               biosimilars) other than anti-tumor necrosis factor (anti-TNF) agent in RA, has&#xD;
               demonstrated inadequate response (IR) or intolerance to the therapy based on one of&#xD;
               the following:&#xD;
  &#xD;
                 1. IR to at least 1bDMARD (or the biosimilars) other than anti-TNF agents, as&#xD;
                    assessed by the treating physician, after at least 12 weeks of therapy including&#xD;
                    but not limited to abatacept, anakinra, tocilizumab, and sarilumab or at least 16&#xD;
                    weeks of therapy with rituximab Documented IR may include inadequate improvement&#xD;
                    or loss in response after initial improvement in joint counts or other parameters&#xD;
                    of disease activity&#xD;
  &#xD;
                 2. Intolerance to bDMARD (or biosimilars) other than anti-TNF agent, as assessed by&#xD;
                    the treating physician. Documented intolerance includes side effects and&#xD;
                    injection or infusion reactions&#xD;
  &#xD;
            -  If has received prior anti-TNF agent (including biosimilars), has demonstrated IR to&#xD;
               &gt;=1 anti-TNF agent (including biosimilars), as assessed by the treating physician:&#xD;
  &#xD;
                 1. After at least 12 weeks dosage of etanercept, adalimumab, golimumab (including&#xD;
                    biosimilars), and/or&#xD;
  &#xD;
                 2. After at least 14 weeks dosage (example, at least 4 doses) of infliximab&#xD;
                    (including biosimilars) Documented IR may include inadequate improvement or loss&#xD;
                    in response after initial improvement in joint counts or other parameters of&#xD;
                    disease activity&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has a confirmed or suspected clinical immunodeficiency syndrome not related to&#xD;
               treatment of RA or has a family history of congenital or hereditary immunodeficiency&#xD;
               unless confirmed absent&#xD;
  &#xD;
            -  Is (anatomically or functionally) asplenic&#xD;
  &#xD;
            -  Has experienced myocardial infarction, unstable ischemic heart disease, or stroke less&#xD;
               than or equal to (&lt;=) 12 weeks of screening&#xD;
  &#xD;
            -  Has a diagnosis of congestive heart failure including medically controlled,&#xD;
               asymptomatic congestive heart failure&#xD;
  &#xD;
            -  Has a history of known demyelinating disease such as multiple sclerosis or optic&#xD;
               neuritis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
      <role>Study Director</role>
      <affiliation>Janssen Research &amp; Development, LLC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Study Contact</last_name>
      <phone>844-434-4210</phone>
      <email>Participate-In-This-Study@its.jnj.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Inland Rheumatology Clinical Trials Inc.</name>
        <address>
          <city>Upland</city>
          <state>California</state>
          <zip>91786</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Integral Rheumatology &amp; Immunology Specialists</name>
        <address>
          <city>Plantation</city>
          <state>Florida</state>
          <zip>33324</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Southwest Rheumatology Research LLC</name>
        <address>
          <city>Mesquite</city>
          <state>Texas</state>
          <zip>75150</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 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>Certolizumab Pegol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu</ipd_description>
      <ipd_url>https://www.janssen.com/clinical-trials/transparency</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06028438
  org study id: CR109343
  secondary id: 2023-504045-31-00
  secondary id: 80202135ARA2002
  nct id: NCT06028438
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab
        and certolizumab compared to certolizumab monotherapy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Change from Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12
  time frame: Baseline, Week 12
  description: Change from baseline in DAS28-CRP score at Week 12 will be reported. DAS28-CRP is combined index used to assess rheumatoid arthritis (RA) disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), CRP, and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP)1, MCP2, MCP3, MCP4, MCP5, proximal interphalangeal (PIP)1, PIP2, PIP3, PIP4, PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. Lower scores indicate better disease control and higher scores indicate worse disease control.
  measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 12
  time frame: At Week 12
  description: Percentage of participants achieving ACR 20 response at Week 12 will be reported. ACR 20 response is defined as greater than or equal to (>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >= 20% improvement from baseline in 3 of 5 assessments: patient's global assessment of disease activity (arthritis, visual analog scale [VAS]; 0-100 mm, 0=excellent and 100=poor), patient's assessment of pain by VAS (VAS; 0-100 millimeter [mm], 0=no pain and 100=worst possible pain), patient's assessment of physical function measured by health assessment questionnaire-disability index (HAQ-DI), defined as a 20-question instrument assessing 8 functional areas, range: 0-3, 0=no difficulty, 3=inability to perform a task in that area, physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity, and 100=extremely active arthritis), and CRP.
  measure: Percentage of Participants Achieving ACR 50 Response at Week 12
  time frame: At Week 12
  description: Percentage of participants achieving ACR 50 response at Week 12 will be reported. ACR 50 response is defined as >= 50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >= 50% improvement from baseline in 3 of 5 assessments: patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), patient's assessment of pain by visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas, range: 0-3, 0=no difficulty, 3=inability to perform a task in that area, physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and CRP.
  measure: Percentage of Participants Achieving ACR 70 Response at Week 12
  time frame: At Week 12
  description: Percentage of participants achieving ACR 70 response at Week 12 will be reported. ACR70 response is defined as >= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of 5 assessments: patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), patient's assessment of pain by visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas), range: 0-3, 0=no difficulty, 3=inability to perform a task in that area, physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and CRP.
  measure: Percentage of Participants Achieving ACR90 Response at Week 12
  time frame: At Week 12
  description: Percentage of participants achieving ACR 90 response at Week 12 will be reported. ACR 90 response is defined as >= 90% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >= 90% improvement from baseline in 3 of 5 assessments: patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), patient's assessment of pain by visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas), range: 0-3, 0=no difficulty, 3=inability to perform a task in that area, physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and CRP.
  measure: Percentage of Participants Achieving DAS28-CRP Remission at Week 12
  time frame: At Week 12
  description: Percentage of participants achieving DAS28-CRP level for remission at Week 12 will be reported. DAS28-CRP remission is defined as DAS28-CRP value less than (<) 2.6 at the analysis visit.
  measure: Percentage of Participants Achieving DAS28-CRP Low Disease Activity (LDA) at Week 12
  time frame: At Week 12
  description: Percentage of participants achieving DAS28-CRP level for LDA at Week 12 will be reported. DAS28 LDA is defined as a DAS28 value of less than or equal to (<=) 3.2 at the analysis visit.
  measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
  time frame: Baseline, Week 12
  description: Change from baseline in HAQ-DI score at Week 12 will be reported. The functional status of the participant will be assessed using the HAQ-DI. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Lower scores are indicative of better functioning.
  measure: Change From Baseline in Clinical Disease Activity Index Score (CDAI) at Week 12
  time frame: Baseline, Week 12
  description: Change from baseline in CDAI score to Week 12 will be reported. The CDAI score is a derived combined index used to assess rheumatoid arthritis (RA) disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient's global assessment of disease activity (arthritis, VAS; 0-10 centimeter (cm), 0=excellent and 10= poor), and physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis). CDAI total score ranges from 0 to 76.
  measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
  time frame: Up to Week 30
  description: An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical or biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
  measure: Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
  time frame: Up to Week 30
  description: SAE is any untoward medical occurrence that at any dose results in death, is life-threatening (The participant was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it was more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important. Treatment-emergent SAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.
  measure: Number of Participants With TEAEs Leading to Discontinuation of Study Intervention
  time frame: Up to Week 30
  description: Number of participants with TEAEs leading to discontinuation of study intervention will be reported. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
  measure: Number of Participants With Adverse Events of Special interests (AESIs)
  time frame: Up to Week 30
  description: Number of participants with AESIs will be reported. TEAEs associated with the following situations are considered to be AESIs: Infections that are severe or require intravenous (IV) anti-infective or operative or invasive intervention, clinically significant opportunistic infection (for example, active TB, invasive fungal infections), hypoalbuminemia with albumin level <20 gram per liter (g/L), and any newly identified malignancies.
  An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product.
  arm group label: Certolizumab + Placebo
  arm group type: Active Comparator
  description: Participants will receive placebo intravenously (IV) and certolizumab dose 1 subcutaneously at Week 0, 2, and 4 followed by placebo IV and certolizumab dose 2 subcutaneously at Weeks 6 to 22.
  arm group label: Certolizumab + Nipocalimab
  arm group type: Experimental
  description: Participants will receive nipocalimab IV and certolizumab dose 1 subcutaneously at Week 0, 2, and 4 followed by nipocalimab IV and certolizumab dose 2 subcutaneously at Weeks 6 to 22.
  intervention type: Drug
  intervention name: Placebo
  description: Placebo will be administered intravenously.
  arm group label: Certolizumab + Placebo
  intervention type: Drug
  intervention name: Nipocalimab
  description: Nipocalimab will be administered intravenously.
  arm group label: Certolizumab + Nipocalimab
  other name: JNJ-80202135
  other name: M281
  intervention type: Drug
  intervention name: Certolizumab
  description: Certolizumab will be administered subcutaneously.
  arm group label: Certolizumab + Nipocalimab
  arm group label: Certolizumab + Placebo
  other name: Cimzia
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Janssen Research & Development, LLC Clinical Trial
  role: Study Director
  affiliation: Janssen Research & Development, LLC
  last name: Study Contact
  phone: 844-434-4210
  email: Participate-In-This-Study@its.jnj.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Arthritis
  mesh term: Arthritis, Rheumatoid
  mesh term: Certolizumab Pegol
  sharing ipd: Yes
  ipd description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
  ipd url: https://www.janssen.com/clinical-trials/transparency