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To evaluate the safety and efficacy of SHR0302 tablets (SHR0302) in subjects with moderate to severe active rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR0302 dose level 1 | Experimental |
| |
| SHR0302 dose level 2 | Experimental |
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| SHR0302 dose level 3 | Experimental |
| |
| SHR0302 dose level 4 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0302 | Drug | Oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12 | Baseline - Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 24 | Baseline - Week 24 | |
| Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 12 | Baseline - Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaofeng Zeng | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | 100032 | China |
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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 | Oral tablets |
|
| Percentage of subjects achieving an American College of Rheumatology (ACR)50 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 an American College of Rheumatology (ACR)70 response at Week 24 | Baseline - Week 24 |
| Percentage of subjects achieving DAS28-3(CRP)<2.6 at Week 12 | Baseline - Week 12 |
| Percentage of subjects achieving DAS28-3(CRP)<2.6 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 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |