<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/NCT03830203</url>
  </required_header>
  <id_info>
    <org_study_id>BAT-1806-002-CR</org_study_id>
    <nct_id>NCT03830203</nct_id>
  </id_info>
  <brief_title>Comparative Study of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate</brief_title>
  <official_title>A Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bio-Thera Solutions</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bio-Thera Solutions</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 3, multicenter, multinational, randomized, double-blind, parallel-group,&#xD;
      active-control study to compare efficacy, safety, immunogenicity, and PK of BAT1806 compared&#xD;
      with RoActemra in subjects with RA that is inadequately controlled by MTX.&#xD;
&#xD;
      The study is composed of a ≤ 28-day screening period, a 24-week initial treatment period&#xD;
      (TP1), a 24 week secondary treatment period (TP2), and an extra 4-week follow-up period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 19, 2018</start_date>
  <completion_date type="Actual">January 5, 2021</completion_date>
  <primary_completion_date type="Actual">January 5, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response</measure>
    <time_frame>6 months</time_frame>
    <description>ACR20 response, ≥ 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and = at least 20% improvement in at least 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (ESR).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in DAS28</measure>
    <time_frame>1 year</time_frame>
    <description>The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (&gt;5.1=high disease activity; &lt;=3.2=low disease activity; &lt;2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity measured on a visual analogue scale (VAS) of 100 mm). Change equals (=) Week X observation minus (-) Baseline observation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of Participants With an ACR20 Response</measure>
    <time_frame>1 year</time_frame>
    <description>ACR20 response, ≥ 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and = at least 20% improvement in at least 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (ESR).</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With an ACR50 Response</measure>
    <time_frame>1 year</time_frame>
    <description>ACR50 response: ≥ 50% improvement in tender joint count; = ≥50% improvement in swollen joint count; and = at least 50% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With an ACR70 Response</measure>
    <time_frame>1 year</time_frame>
    <description>ACR70 response: ≥ 70% improvement in tender joint count; = ≥70% improvement in swollen joint count; and = at least 70% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">621</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>BAT1806</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BAT1806 injection: 8 mg/kg, intravenous infusion by 60 min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Actemra(EU-licensed)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Actemra(EU-licensed): 8 mg/kg, intravenous infusion by 60 min</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAT1806</intervention_name>
    <description>8 mg/kg</description>
    <arm_group_label>BAT1806</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Actemra(EU-licensed)</intervention_name>
    <description>8 mg/kg</description>
    <arm_group_label>Actemra(EU-licensed)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects 18 years of age or older who fulfil the American College of&#xD;
             Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 revised&#xD;
             classification criteria for RA diagnosis for at least 6 months before screening, based&#xD;
             on the medical history record.&#xD;
&#xD;
          2. Subject presents with active RA, as defined by:&#xD;
&#xD;
               1. ≥ 6 out of 68 tender joints (at screening and randomization) AND&#xD;
&#xD;
               2. ≥ 6 out of 66 swollen joints (at screening and randomization) AND&#xD;
&#xD;
               3. Serum C-reactive protein (CRP) &gt; upper limit of normal (ULN) value or erythrocyte&#xD;
                  sedimentation rate (ESR) ≥ 28 mm/hour at screening.&#xD;
&#xD;
          3. Subjects are eligible if they have received not more than 2 biological agents other&#xD;
             than interleukin-6 inhibitors or targeted synthetic DMARDs (eg, tofacitinib) in total&#xD;
             for RA treatment.&#xD;
&#xD;
          4. Female subjects of childbearing potential and male subjects with a female partner of&#xD;
             childbearing potential must be willing to take reliable contraceptive precautions&#xD;
             throughout the study period and continuing for at least 3 months after the last dose&#xD;
             of study drug. Reliable methods of contraception include: intrauterine device,&#xD;
             hormonal contraceptives (eg, oral, patch, or injectable), male vasectomy (if vasectomy&#xD;
             was medically confirmed), a barrier protection method (eg, condom or diaphragm) in&#xD;
             association with spermicide cream, foam, or gel. Abstinence from heterosexual&#xD;
             intercourses is accepted when this is the usual lifestyle of the subject and must be&#xD;
             continued for at least 3 months after the last dose of study drug. A female subject is&#xD;
             considered not of child-bearing potential when postmenopausal (at least 12 consecutive&#xD;
             months without menses without an alternative medical cause) or surgically sterilized&#xD;
             (bilateral tubal ligation, bilateral oophorectomy with or without hysterectomy).&#xD;
&#xD;
          5. If female of childbearing potential, subject should have a negative pregnancy test&#xD;
             result at screening and baseline visit.&#xD;
&#xD;
          6. Subjects must be willing to provide written consent and to comply with the&#xD;
             requirements of the study protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has RA of ACR functional class IV or is wheelchair/bed bound.&#xD;
&#xD;
          2. Known hypersensitivity to tocilizumab or to study treatment excipients.&#xD;
&#xD;
          3. Subject has received any cell-depleting therapy (eg, rituximab) ≤ 12 months prior to&#xD;
             randomization.&#xD;
&#xD;
          4. Subject has been treated with an investigational drug other than those prohibited or&#xD;
             device ≤ 8 weeks or 5 half-lives of the drug (whichever is longer) prior to&#xD;
             randomization.&#xD;
&#xD;
          5. Subject has undergone joint surgery ≤ 12 weeks prior to randomization (on any joint to&#xD;
             be assessed during the study) or has any surgery planned during the study.&#xD;
&#xD;
          6. Evidence of malignancy, lung infection, or abnormalities suggestive of active&#xD;
             tuberculosis (TB) on chest radiography performed within 12 weeks prior to the&#xD;
             Screening Visit or during the screening period.&#xD;
&#xD;
          7. Any recurrent bacterial, fungal, or viral infection that based on the investigator´s&#xD;
             clinical assessment makes the subject unsuitable for the study, including&#xD;
             recurrent/disseminated herpes zoster.&#xD;
&#xD;
          8. Current or history of diverticulitis, complications of diverticulitis, history of&#xD;
             diverticulosis requiring antibiotic treatment, current or history of chronic&#xD;
             ulcerative lower gastrointestinal tract diseases or any other lower gastrointestinal&#xD;
             condition that may predispose to perforation.&#xD;
&#xD;
          9. Any history of malignancy or lymphoproliferative disease at any time, except curative&#xD;
             treatment for nonmelanoma skin cancer or resected carcinoma in situ of the cervix.&#xD;
&#xD;
         10. Have a transplanted organ/tissue or stem cell transplantation.&#xD;
&#xD;
         11. Subject has an underlying metabolic, hematologic, renal, hepatic, pulmonary,&#xD;
             neurologic, endocrine, cardiac, infectious, or gastrointestinal condition, which in&#xD;
             the opinion of the investigator places the subject at unacceptable risk.&#xD;
&#xD;
         12. Subject has a history of demyelinating diseases (including myelitis) or neurologic&#xD;
             symptoms suggestive of demyelinating disease.&#xD;
&#xD;
         13. Subject has received any live or attenuated vaccine ≤ 4 weeks prior to randomization&#xD;
             or plans to receive it during the study including the safety follow up period.&#xD;
&#xD;
         14. Subject has a history of clinically significant drug or alcohol abuse in the last 12&#xD;
             months as judged by the investigator.&#xD;
&#xD;
         15. Pregnant or nursing (lactating) women.&#xD;
&#xD;
         16. Subject is considered by the investigator, for any reason, to be an unsuitable&#xD;
             candidate for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaofeng Zeng</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>November 16, 2021</last_update_submitted>
  <last_update_submitted_qc>November 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2021</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03830203
org study id: BAT-1806-002-CR
nct id: NCT03830203
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a Phase 3, multicenter, multinational, randomized, double-blind, parallel-group,
      active-control study to compare efficacy, safety, immunogenicity, and PK of BAT1806 compared
      with RoActemra in subjects with RA that is inadequately controlled by MTX.

      The study is composed of a ≤ 28-day screening period, a 24-week initial treatment period
      (TP1), a 24 week secondary treatment period (TP2), and an extra 4-week follow-up period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response
time frame: 6 months
description: ACR20 response, ≥ 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and = at least 20% improvement in at least 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (ESR).
measure: Change From Baseline in DAS28
time frame: 1 year
description: The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity measured on a visual analogue scale (VAS) of 100 mm). Change equals (=) Week X observation minus (-) Baseline observation.
measure: Percentage of Participants With an ACR20 Response
time frame: 1 year
description: ACR20 response, ≥ 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and = at least 20% improvement in at least 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (ESR).
measure: Percentage of Participants With an ACR50 Response
time frame: 1 year
description: ACR50 response: ≥ 50% improvement in tender joint count; = ≥50% improvement in swollen joint count; and = at least 50% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).
measure: Percentage of Participants With an ACR70 Response
time frame: 1 year
description: ACR70 response: ≥ 70% improvement in tender joint count; = ≥70% improvement in swollen joint count; and = at least 70% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).
arm group label: BAT1806
arm group type: Experimental
description: BAT1806 injection: 8 mg/kg, intravenous infusion by 60 min
arm group label: Actemra(EU-licensed)
arm group type: Active Comparator
description: Actemra(EU-licensed): 8 mg/kg, intravenous infusion by 60 min
intervention type: Drug
intervention name: BAT1806
description: 8 mg/kg
arm group label: BAT1806
intervention type: Drug
intervention name: Actemra(EU-licensed)
description: 8 mg/kg
arm group label: Actemra(EU-licensed)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xiaofeng Zeng
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No