Efficacy and Safety of Telitacicept in the Treatment of Refractory Rheumatoid Arthritis
NCT07796516 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 420
Last updated 2026-09-01
Summary
This study is a multicenter, open-label, randomized controlled trial designed to preliminarily evaluate the efficacy and safety of telitacicept in patients with refractory rheumatoid arthritis during a 24-week treatment period followed by a 2-week follow-up period.
Conditions
- Difficult-to-treat Rheumatoid Arthritis
- Rheumatoid Arthritis
Interventions
- BIOLOGICAL
-
Telitacicept 160mg
Telitacicept 160 mg will be administered subcutaneously once weekly for 24 consecutive weeks.
- DRUG
-
Standard therapy
Standard therapy includes DMARDs, GCs, and NSAIDs.
Sponsors & Collaborators
-
Peking University People's Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-01
- Primary Completion
- 2027-12-30
- Completion
- 2028-06-30
Countries
- China
Study Locations
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