Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of SHR0302 tablets (SHR0302) in subjects with moderate to severe active rheumatoid arthritis.

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: SHR0302
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR0302 dose level 1<br> | Drug: SHR0302<br>* Oral tablets<br>|
| Experimental: SHR0302 dose level 2<br> | Drug: SHR0302<br>* Oral tablets<br>|
| Experimental: SHR0302 dose level 3<br> | Drug: SHR0302<br>* Oral tablets<br>|
| Experimental: SHR0302 dose level 4<br> | Drug: SHR0302<br>* Oral tablets<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12 |  | Baseline - Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 24 |  | Baseline - Week 24 | 
| 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 an American College of Rheumatology (ACR)70 response at Week 12 |  | Baseline - Week 12 | 
| Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 24 |  | Baseline - Week 24 | 
| Percentage of subjects achieving DAS28-3（CRP）<2.6 at Week 12 |  | Baseline - Week 12 | 
| Percentage of subjects achieving DAS28-3（CRP）<2.6 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 |