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A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT04333771
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with moderate to severe active rheumatoid arthritis who had inadequate response to conventional synthetic DMARDs.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: SHR0302 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Moderate to Severe Active Rheumatoid Arthritis Subjects With Inadequate Response to csDMARDs.
Actual Study Start Date : July 31, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.

Experimental: SHR0302 dose1 Drug: SHR0302
The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.

Experimental: SHR0302 dose2 Drug: SHR0302
The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.




Primary Outcome Measures :
  1. ACR20 response rate at week 24 [ Time Frame: Week 24 ]
    Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 24


Secondary Outcome Measures :
  1. ACR20 response rate at week 52 [ Time Frame: Week 52 ]
    Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 52

  2. ACR50 response rate at week 24 and week 52 [ Time Frame: Week 24 and week 52 ]
    Response rate of 50% improvement in American College of Rheumatology (ACR50) criteria at week 24 and week 52

  3. ACR70 response rate at week 24 and week 52 [ Time Frame: Week 24 and week 52 ]
    Response rate of 70% improvement in American College of Rheumatology (ACR70) criteria at week 24 and week 52

  4. Change from baseline in HAQ-DI score at week 24 and week 52 [ Time Frame: Week 24 and week 52 ]
    Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score at week 24 and week 52

  5. Change from baseline in SF-36 score at week 24 and week 52 [ Time Frame: Week 24 and week 52 ]
    Change from baseline in the medical outcomes study 36-Item Short-Form Health Survey (SF-36) score at week 24 and week 52

  6. DAS28-CRP <2.6 proportion at week 24 and week 52 [ Time Frame: Week 24 and week 52 ]
    Disease Activity Score for 28-joint counts based on the c-reaction protein (DAS28-CRP) of less than 2.6

  7. DAS28-CRP≤3.2 proportion at week 24 and week 52 [ Time Frame: Week 24 and week 52 ]
    Disease Activity Score for 28-joint counts based on the c-reaction protein (DAS28-CRP) of equal to and less than 3.2



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide signed informed consent.
  • RA diagnosis consistent with the 2010 ACR/EULAR criteria;
  • Moderate to severe RA defined by 6 or more tender joints, 6 or more swollen joints (68- or 66-joint count), and an ESR of 28 mm/h or greater or a CRP level greater than 5mg/L.
  • Subjects were required to have an inadequate response to treatment with csDMARDs before baseline.
  • If subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline , the stable doses should have lasted for more than 4 weeks already.
  • BMI ≥18 kg/m2

Exclusion Criteria:

  • Pregnant women or refuse to receive contraception during the study.
  • Lab abnormality within 4 weeks of randomization as follows: WBC count <3.0×10^9/L;neutrophil count<1.5×10^9/L;hemoglobin level<90.0 g/L ; platelet count <100×10^9/L; AST or ALT levels greater than the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
  • History of another autoimmune rheumatic disease ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
  • Previous treatment with JAK inhibitor or cytotoxic drugs; bDMARDs within 6 months of randomization; other strong immunosuppressants within 3 months of randomization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333771


Contacts
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Contact: Yang Shen, M.D +86 021-61053363 shenyang@hrglobe.cn
Contact: Ying Yang yangying@hrglobe.cn

Locations
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China, Guangxi
Liuzhou workers' Hospital Recruiting
Liuzhou, Guangxi, China
Principal Investigator: Xinghui Song         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04333771    
Other Study ID Numbers: SHR0302-301
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases