<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/NCT03254966</url>
  </required_header>
  <id_info>
    <org_study_id>SHR0302-201</org_study_id>
    <nct_id>NCT03254966</nct_id>
  </id_info>
  <brief_title>Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients</brief_title>
  <official_title>Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Safety and Efficacy of SHR0302 in Patients With Moderate to Severe Active Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu HengRui Medicine Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and efficacy of SHR0302 tablets (SHR0302) in subjects with moderate to&#xD;
      severe active rheumatoid arthritis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 24, 2017</start_date>
  <completion_date type="Actual">October 12, 2019</completion_date>
  <primary_completion_date type="Actual">April 16, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12</measure>
    <time_frame>Baseline - Week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 24</measure>
    <time_frame>Baseline - Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 12</measure>
    <time_frame>Baseline - Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 24</measure>
    <time_frame>Baseline - Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 12</measure>
    <time_frame>Baseline - Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 24</measure>
    <time_frame>Baseline - Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving DAS28-3（CRP）&lt;2.6 at Week 12</measure>
    <time_frame>Baseline - Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects achieving DAS28-3（CRP）&lt;2.6 at Week 24</measure>
    <time_frame>Baseline - Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 12</measure>
    <time_frame>Baseline - Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 24</measure>
    <time_frame>Baseline - Week 24</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">194</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>SHR0302 dose level 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SHR0302 dose level 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SHR0302 dose level 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SHR0302 dose level 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SHR0302</intervention_name>
    <description>Oral tablets</description>
    <arm_group_label>SHR0302 dose level 1</arm_group_label>
    <arm_group_label>SHR0302 dose level 2</arm_group_label>
    <arm_group_label>SHR0302 dose level 3</arm_group_label>
    <arm_group_label>SHR0302 dose level 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral tablets</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female subjects who are 18 - 70 (inclusive) years of age on the day of signing&#xD;
             informed consent&#xD;
&#xD;
          -  have a diagnosis of RA meeting the 2010 ACR/EULAR criteria of RA and ACR functional&#xD;
             class I-III&#xD;
&#xD;
          -  have ≥6 swollen joints (from a 66-joint count) and ≥8 tender joints (from a 68-joint&#xD;
             count) at Screening and at Baseline, Screening serum c-reactive protein (CRP)or hsCRP&#xD;
             &gt; 1.2 x upper limit of laboratory normal range (ULN),or erythrocyte sedimentation rate&#xD;
             (ESR) &gt; 28 mm/h&#xD;
&#xD;
          -  have not used any disease modifying anti-rheumatic drug (DMARD) or have an inadequate&#xD;
             response to one or more kinds of conditional DMARDs (methotrexate, leflunomide,&#xD;
             Chloroquine, hydroxychloroquine, sulfasalazine, minocycline, penicillamine, auranofin&#xD;
             or injection gold preparation, and iguratimod) due to lack of efficacy or toxicity,&#xD;
             and have agreed to be washed out from these conditional DMARDs for a period of at&#xD;
             least 7 t1/2s prior to randomization, with the exception of antimalarials, which must&#xD;
             be at a stable dose for at least 12 weeks prior to randomization&#xD;
&#xD;
          -  Body mass index (BMI = weight/height squared (kg/m2)) within the range of 18 to 35,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current or previous RA treatment with a jak inhibitor&#xD;
&#xD;
          -  current or previous RA treatment with a biologic DMARD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</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>
        <zip>100032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>September 24, 2021</last_update_submitted>
  <last_update_submitted_qc>September 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 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>Undecided</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/NCT03254966
org study id: SHR0302-201
nct id: NCT03254966
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate the safety and efficacy of SHR0302 tablets (SHR0302) in subjects with moderate to
      severe active rheumatoid arthritis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12
time frame: Baseline - Week 12
measure: Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 24
time frame: Baseline - Week 24
measure: Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 12
time frame: Baseline - Week 12
measure: Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 24
time frame: Baseline - Week 24
measure: Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 12
time frame: Baseline - Week 12
measure: Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 24
time frame: Baseline - Week 24
measure: Percentage of subjects achieving DAS28-3（CRP）<2.6 at Week 12
time frame: Baseline - Week 12
measure: Percentage of subjects achieving DAS28-3（CRP）<2.6 at Week 24
time frame: Baseline - Week 24
measure: Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 12
time frame: Baseline - Week 12
measure: Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 24
time frame: Baseline - Week 24
arm group label: SHR0302 dose level 1
arm group type: Experimental
arm group label: SHR0302 dose level 2
arm group type: Experimental
arm group label: SHR0302 dose level 3
arm group type: Experimental
arm group label: SHR0302 dose level 4
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: SHR0302
description: Oral tablets
arm group label: SHR0302 dose level 1
arm group label: SHR0302 dose level 2
arm group label: SHR0302 dose level 3
arm group label: SHR0302 dose level 4
intervention type: Drug
intervention name: Placebo
description: Oral tablets
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
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: Undecided