A Phase IIa Study of JAB-8263 in Patients With Active Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JAB-8263, JAB-8263.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis (RA). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase Randomized, Double-blind, Placebo-controlled Evaluate the Efficacy and Safety IIa Study of JAB-8263 in Patients With Active Rheumatoid Arthritis
Overview
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
- Drug JAB-8263
Variable dose1, orally Q2D with 28 days - Drug JAB-8263
Variable dose2, orally Q2D with 28 days
Primary outcome measures
- Evaluate the overall safety and tolerability of JAB-8263 [Time frame: Up to approximately 12week]
Secondary outcome measures (5)
- American College of Rheumatology 20 Response Rate (ACR20 Response Rate) [Time frame: Up to approximately 12week]
- American College of Rheumatology 50 Response Rate (ACR50 Response Rate) [Time frame: Up to approximately 12week]
- American College of Rheumatology 70 Response Rate (ACR70 Response Rate) [Time frame: Up to approximately 12week]
- Clinical Disease Activity Index Good Response Rate (CDAI Good Response Rate) [Time frame: Up to approximately 12week]
- Simplified Disease Activity Index Good Response Rate (SDAI Good Response Rate) [Time frame: Up to approximately 12week]
Eligibility criteria
Inclusion criteria
- Age ≥18 years old and <75 years old at the time of signing the informed consent form, regardless of gender;
- Active rheumatoid arthritis, ESR or C-reactive protein> upper limit of normal
- Meets the 2010 American College of Rheumatology ACR/EULAR RA classification standards
- Participants have recovered from adverse reactions to previous antirheumatic treatment.
Exclusion criteria
- 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;
- Use of NSAIDs within 1 week before first dose of investigational product
- Known or suspected allergies to the investigational product or any of its components;
- 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);
- Have evidence of active tuberculosis (TB) or have previously had evidence of active TB and have not received appropriate documented treatment;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Hospital — Beijing
Identifiers
NCT: NCT07684157 · JAB-8263-2001