Status:
COMPLETED
Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
To evaluate the safety and efficacy of SHR0302 tablets (SHR0302) in subjects with moderate to severe active rheumatoid arthritis.
Eligibility Criteria
Inclusion
- male or female subjects who are 18 - 70 (inclusive) years of age on the day of signing informed consent
- have a diagnosis of RA meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III
- have ≥6 swollen joints (from a 66-joint count) and ≥8 tender joints (from a 68-joint count) at Screening and at Baseline, Screening serum c-reactive protein (CRP)or hsCRP \> 1.2 x upper limit of laboratory normal range (ULN),or erythrocyte sedimentation rate (ESR) \> 28 mm/h
- have not used any disease modifying anti-rheumatic drug (DMARD) or have an inadequate response to one or more kinds of conditional DMARDs (methotrexate, leflunomide, Chloroquine, hydroxychloroquine, sulfasalazine, minocycline, penicillamine, auranofin or injection gold preparation, and iguratimod) due to lack of efficacy or toxicity, and have agreed to be washed out from these conditional DMARDs for a period of at least 7 t1/2s prior to randomization, with the exception of antimalarials, which must be at a stable dose for at least 12 weeks prior to randomization
- Body mass index (BMI = weight/height squared (kg/m2)) within the range of 18 to 35,
Exclusion
- current or previous RA treatment with a jak inhibitor
- current or previous RA treatment with a biologic DMARD
Key Trial Info
Start Date :
November 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2019
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT03254966
Start Date
November 24 2017
End Date
October 12 2019
Last Update
September 30 2021
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China, 100032