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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| SHR0302 dose1 | Experimental |
| |
| SHR0302 dose2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0302 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 response rate at week 24 | Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 24 | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 response rate at week 52 | Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 52 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liuzhou workers' Hospital | Liuzhou | Guangxi | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39919893 | Derived | Liu J, Jiang Y, Zhang S, Liu S, Su J, Lin C, He X, Wu R, Yang L, Liu H, Duan X, Xu S, Luo H, Liu J, Xie Q, Mi C, Chen L, Zhang N, Gong H, Zhu J, Li Y, Wei H, Qian L, Wang J, Shi X, Jin H, Jiang Z, Xie X, Zhan F, Geng X, Zheng Z, Du Z, Dong G, Sun Y, Zeng X. Ivarmacitinib, a selective Janus kinase 1 inhibitor, in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: results from a phase III randomised clinical trial. Ann Rheum Dis. 2025 Feb;84(2):188-200. doi: 10.1136/ard-2024-226385. Epub 2025 Jan 3. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000615713 | ivarmacitinib |
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| Placebo | Drug | 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. |
|
| 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 | 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 | 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 | 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 | Week 24 and week 52 |
| 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 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |