drugset / Trial / NCT07796516
Efficacy and Safety of Telitacicept in the Treatment of Refractory Rheumatoid Arthritis
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-09-01
- Primary completion
- 2027-12-30
- Completion
- 2028-06-30
Publications
- Results Cohen SB, Emery P, Greenwald MW, Dougados M, Furie RA, Genovese MC, Keystone EC, Loveless JE, Burmester GR, Cravets MW, Hessey EW, Shaw T, Totoritis MC; REFLEX Trial Group. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006 Sep;54(9):2793-806. doi: 10.1002/art.22025.
- Results Tao Y, Zhang J, Li H, Zhou J, Wu M. Clinical efficacy and safety of telitacicept combined with methotrexate in the treatment of rheumatoid arthritis. Am J Transl Res. 2026 Apr 15;18(4):3220-3229. doi: 10.62347/PKWI2684. eCollection 2026.
- Results Hofman ZLM, Roodenrijs NMT, Nikiphorou E, Kent AL, Nagy G, Welsing PMJ, van Laar JM. Difficult-to-treat rheumatoid arthritis: what have we learned and what do we still need to learn? Rheumatology (Oxford). 2025 Jan 1;64(1):65-73. doi: 10.1093/rheumatology/keae544.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Telitacicept | Protein / enzyme biologic | 160 mg | Subcutaneous |