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This study is a phase 3 study,to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with active psoriatic arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | SHR0302 tablets dose 1+ Placebo dose 2 |
|
| Treatment group B | Experimental | SHR0302 tablets dose 2+ Placebo dose 1 |
|
| Treatment group C | Placebo Comparator | Placebo dose1 + placebo dose 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0302 tablets、Placebo | Drug | SHR0302 tablets dose 1 for 48 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 response rate at week 24 | Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20) at week 24 | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 response rate at week 48 | Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20) at week 48 | Week 48 |
| ACR50/70 response rate at week 24 and week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Hospital | Beijing | Beijing Municipality | 200433 | China |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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SHR0302 tablets compared with placebo
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| SHR0302 tablets、Placebo |
| Drug |
SHR0302 tablets dose 2 for 48 weeks |
|
| Placebo | Drug | SHR0302 tablets blank preparation for 24 weeks then SHR0302 tablets dose 1/dose 2 for 24 weeks |
|
Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 50%/70% (ACR50/70) at week 24 and week 48
| Week 24 and week48 |
| Change from baseline in DAS28-CRP week 24 and week 48 | Change from baseline in the disease activity score-CRP(DAS 28-CRP) at week 24 and week 48 | Week 24 and week 48 |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |