Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is an open-label, multi-center Phase IIa study. The study is divided into two phases. The first phase is a safety exploration phase. Participants with active rheumatoid arthritis were enrolled and treated with JAB-8263 alone for 4 weeks. The purpose is to evaluate the safety, PK/PD characteristics and preliminary effectiveness of JAB-8263 in participants with active RA.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JAB-8263 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JAB-8263 | Drug | Variable dose1, orally Q2D with 28 days |
| |
| JAB-8263 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the overall safety and tolerability of JAB-8263 | Safety assessments including but not limited to TEAEs, SAEs, deaths and changes in clinical laboratory measures | Up to approximately 12week |
| Measure | Description | Time Frame |
|---|---|---|
| American College of Rheumatology 20 Response Rate (ACR20 Response Rate) | the percentage of patients who meet the ACR20 response criteria | Up to approximately 12week |
| American College of Rheumatology 50 Response Rate (ACR50 Response Rate) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Yang Jun Project Director | Contact | clinicaltrials@jacobiopharma.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Variable dose2, orally Q2D with 28 days |
|
the percentage of participants who meet the ACR50 response criteria
| Up to approximately 12week |
| American College of Rheumatology 70 Response Rate (ACR70 Response Rate) | the percentage of participants who meet the ACR70 response criteria | Up to approximately 12week |
| Clinical Disease Activity Index Good Response Rate (CDAI Good Response Rate) | the percentage of participants who achieve a good clinical response based on the Clinical Disease Activity Index (CDAI) | Up to approximately 12week |
| Simplified Disease Activity Index Good Response Rate (SDAI Good Response Rate) | the percentage of participants who achieve a good clinical response according to the Simplified Disease Activity Index (SDAI) | Up to approximately 12week |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |