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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Beijing Hospital
Beijing, Beijing Municipality, China
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
Time frame: Up to approximately 12week
American College of Rheumatology 20 Response Rate (ACR20 Response Rate)
the percentage of patients who meet the ACR20 response criteria
Time frame: Up to approximately 12week
American College of Rheumatology 50 Response Rate (ACR50 Response Rate)
the percentage of participants who meet the ACR50 response criteria
Time frame: Up to approximately 12week
American College of Rheumatology 70 Response Rate (ACR70 Response Rate)
the percentage of participants who meet the ACR70 response criteria
Time frame: 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)
Time frame: 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)
Time frame: Up to approximately 12week
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