NCT03254966CompletedPhase 2
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
Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country194 target enrollmentStarted: November 24, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 194
- Locations
- 1
- Primary Endpoint
- Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12
Study Overview
Brief Summary
To evaluate the safety and efficacy of SHR0302 tablets (SHR0302) in subjects with moderate to severe active rheumatoid arthritis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •current or previous RA treatment with a jak inhibitor
- •current or previous RA treatment with a biologic DMARD
Arms & Interventions
SHR0302 dose level 1
Experimental
Intervention: SHR0302 (Drug)
SHR0302 dose level 2
Experimental
Intervention: SHR0302 (Drug)
SHR0302 dose level 3
Experimental
Intervention: SHR0302 (Drug)
SHR0302 dose level 4
Experimental
Intervention: SHR0302 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12
Time Frame: Baseline - Week 12
Secondary Outcomes
- Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 12(Baseline - Week 12)
- Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 24(Baseline - Week 24)
- Percentage of subjects achieving DAS28-3（CRP）<2.6 at Week 24(Baseline - Week 24)
- Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 24(Baseline - Week 24)
- Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 12(Baseline - Week 12)
- Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 24(Baseline - Week 24)
- Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 24(Baseline - Week 24)
- Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 12(Baseline - Week 12)
- Percentage of subjects achieving DAS28-3（CRP）<2.6 at Week 12(Baseline - Week 12)
Investigators
Study Sites (1)
Loading locations...
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