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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254966
• Other study ID #: SHR0302-201
• Status: Completed
• Phase: Phase 2
• Start date: November 24, 2017
• Est. completion date: October 12, 2019

Study information

• Verified date: September 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: October 12, 2019
• Est. primary completion date: April 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• SHR0302
Oral tablets
• Placebo
Oral tablets

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12		Baseline - Week 12
Secondary	Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 24		Baseline - Week 24
Secondary	Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 12		Baseline - Week 12
Secondary	Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 24		Baseline - Week 24
Secondary	Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 12		Baseline - Week 12
Secondary	Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 24		Baseline - Week 24
Secondary	Percentage of subjects achieving DAS28-3(CRP)<2.6 at Week 12		Baseline - Week 12
Secondary	Percentage of subjects achieving DAS28-3(CRP)<2.6 at Week 24		Baseline - Week 24
Secondary	Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 12		Baseline - Week 12
Secondary	Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 24		Baseline - Week 24