Rheumatoid Arthritis (RA)
Conditions
Brief summary
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.
Interventions
DRUGJAB-8263
Variable dose1, orally Q2D with 28 days
Sponsors
Jacobio Pharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years old and \<75 years old at the time of signing the informed consent form, regardless of gender; 2. Active rheumatoid arthritis, ESR or C-reactive protein\> upper limit of normal 3. Meets the 2010 American College of Rheumatology ACR/EULAR RA classification standards 4. Participants have recovered from adverse reactions to previous antirheumatic treatment.
Exclusion criteria
1. Use of topical glucocorticoids within 2 weeks before the first dose of investigational product or have received epidural, intraarticular, intramuscular, oral or intravenous glucocorticoids within 4 weeks, and do not use adrenocorticotropin; 2. Use of NSAIDs within 1 week before first dose of investigational product 3. Known or suspected allergies to the investigational product or any of its components; 4. Current active shingles virus infection, including shingles or herpes simplex types 1 and 2 (confirmed by physical examination and medical history); participants had a history of severe herpes infection, including any disseminated disease, shingles in multiple skin areas, herpes encephalitis, ocular herpes, or recurrent shingles (2 episodes greater than or equal to 2 episodes within 2 years); 5. Have evidence of active tuberculosis (TB) or have previously had evidence of active TB and have not received appropriate documented treatment;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the overall safety and tolerability of JAB-8263 | Up to approximately 12week | Safety assessments including but not limited to TEAEs, SAEs, deaths and changes in clinical laboratory measures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American College of Rheumatology 20 Response Rate (ACR20 Response Rate) | Up to approximately 12week | the percentage of patients who meet the ACR20 response criteria |
| American College of Rheumatology 50 Response Rate (ACR50 Response Rate) | Up to approximately 12week | the percentage of participants who meet the ACR50 response criteria |
| American College of Rheumatology 70 Response Rate (ACR70 Response Rate) | Up to approximately 12week | the percentage of participants who meet the ACR70 response criteria |
| Clinical Disease Activity Index Good Response Rate (CDAI Good Response Rate) | Up to approximately 12week | the percentage of participants who achieve a good clinical response based on the Clinical Disease Activity Index (CDAI) |
| Simplified Disease Activity Index Good Response Rate (SDAI Good Response Rate) | Up to approximately 12week | the percentage of participants who achieve a good clinical response according to the Simplified Disease Activity Index (SDAI) |
Countries
China
Contacts
CONTACTJun Yang Jun Project Director
Outcome results
None listed