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

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SHR0302
Placebo
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Liuzhou workers' HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

SHR0302 dose1

SHR0302 dose2

Arm Description

Outcomes

Primary Outcome Measures

ACR20 response rate at week 24
Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 24

Secondary Outcome Measures

ACR20 response rate at week 52
Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 52
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
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
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
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
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
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

Full Information

First Posted
April 2, 2020
Last Updated
September 16, 2020
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04333771
Brief Title
A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 31, 2020 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
SHR0302 dose1
Arm Type
Experimental
Arm Title
SHR0302 dose2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SHR0302
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
ACR20 response rate at week 24
Description
Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 24
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
ACR20 response rate at week 52
Description
Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 52
Time Frame
Week 52
Title
ACR50 response rate at week 24 and week 52
Description
Response rate of 50% improvement in American College of Rheumatology (ACR50) criteria at week 24 and week 52
Time Frame
Week 24 and week 52
Title
ACR70 response rate at week 24 and week 52
Description
Response rate of 70% improvement in American College of Rheumatology (ACR70) criteria at week 24 and week 52
Time Frame
Week 24 and week 52
Title
Change from baseline in HAQ-DI score at week 24 and week 52
Description
Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score at week 24 and week 52
Time Frame
Week 24 and week 52
Title
Change from baseline in SF-36 score at week 24 and week 52
Description
Change from baseline in the medical outcomes study 36-Item Short-Form Health Survey (SF-36) score at week 24 and week 52
Time Frame
Week 24 and week 52
Title
DAS28-CRP <2.6 proportion at week 24 and week 52
Description
Disease Activity Score for 28-joint counts based on the c-reaction protein (DAS28-CRP) of less than 2.6
Time Frame
Week 24 and week 52
Title
DAS28-CRP≤3.2 proportion at week 24 and week 52
Description
Disease Activity Score for 28-joint counts based on the c-reaction protein (DAS28-CRP) of equal to and less than 3.2
Time Frame
Week 24 and week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Shen, M.D
Phone
+86 021-61053363
Email
shenyang@hrglobe.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Yang
Email
yangying@hrglobe.cn
Facility Information:
Facility Name
Liuzhou workers' Hospital
City
Liuzhou
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinghui Song

12. IPD Sharing Statement

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

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