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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: SHR0302; Drug: Placebo

• Registration Number: NCT03254966
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-21
• Study Start: 2017-11-24
• Primary Completion: 2019-04-16
• Study Completion: 2019-10-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-24
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR0302 dose level 1	SHR0302	-
SHR0302 dose level 2	SHR0302	-
SHR0302 dose level 4	SHR0302	-
Placebo	Placebo	-
SHR0302 dose level 3	SHR0302	-

Primary Outcome Measures

Name	Time	Method
Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12	Baseline - Week 12

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China