A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Moderate to Severe Active Rheumatoid Arthritis Subjects With Inadequate Response to csDMARDs.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04333771
• Other study ID #: SHR0302-301
• Status: Completed
• Phase: Phase 3
• Start date: July 31, 2020
• Est. completion date: September 21, 2023

Study information

• Verified date: November 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with moderate to severe active rheumatoid arthritis who had inadequate response to conventional synthetic DMARDs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: September 21, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Provide signed informed consent.

• RA diagnosis consistent with the 2010 ACR/EULAR criteria;

• Moderate to severe RA defined by 6 or more tender joints, 6 or more swollen joints (68- or 66-joint count), and an ESR of 28 mm/h or greater or a CRP level greater than 5mg/L.

• Subjects were required to have an inadequate response to treatment with csDMARDs before baseline.

• If subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline , the stable doses should have lasted for more than 4 weeks already.

• BMI =18 kg/m2

Exclusion Criteria:

• Pregnant women or refuse to receive contraception during the study.

• Lab abnormality within 4 weeks of randomization as follows: WBC count <3.0×10^9/L;neutrophil count<1.5×10^9/L;hemoglobin level<90.0 g/L ; platelet count <100×10^9/L; AST or ALT levels greater than the upper limit of normal; HBsAg or HCV or HIV antibody positivity.

• History of another autoimmune rheumatic disease ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.

• Previous treatment with JAK inhibitor or cytotoxic drugs; bDMARDs within 6 months of randomization; other strong immunosuppressants within 3 months of randomization.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• SHR0302
The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.
• Placebo
The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.

Locations

Country	Name	City	State
China	Liuzhou workers' Hospital	Liuzhou	Guangxi

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	ACR20 response rate at week 24	Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 24	Week 24
Secondary	ACR20 response rate at week 52	Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 52	Week 52
Secondary	ACR50 response rate at week 24 and week 52	Response rate of 50% improvement in American College of Rheumatology (ACR50) criteria at week 24 and week 52	Week 24 and week 52
Secondary	ACR70 response rate at week 24 and week 52	Response rate of 70% improvement in American College of Rheumatology (ACR70) criteria at week 24 and week 52	Week 24 and week 52
Secondary	Change from baseline in HAQ-DI score at week 24 and week 52	Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score at week 24 and week 52	Week 24 and week 52
Secondary	Change from baseline in SF-36 score at week 24 and week 52	Change from baseline in the medical outcomes study 36-Item Short-Form Health Survey (SF-36) score at week 24 and week 52	Week 24 and week 52
Secondary	DAS28-CRP <2.6 proportion at week 24 and week 52	Disease Activity Score for 28-joint counts based on the c-reaction protein (DAS28-CRP) of less than 2.6	Week 24 and week 52
Secondary	DAS28-CRP=3.2 proportion at week 24 and week 52	Disease Activity Score for 28-joint counts based on the c-reaction protein (DAS28-CRP) of equal to and less than 3.2	Week 24 and week 52