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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-24

Study Completion Date

2019-10-12

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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Oral tablets

Intervention Type DRUG

Placebo

Oral tablets

Intervention Type DRUG

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,