NCT07008196

Telitacicept for the Treatment of Refractory RA

An Exploratory Clinical Study on Telitacicept for the Treatment of Refractory Rheumatoid Arthritis

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chinese SLE Treatment And Research Group · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, single-arm, open-label, prospective study on the efficacy and safety of Telitacicept in patients with refractory rheumatoid arthritis.

Detailed description

The treatment of rheumatoid arthritis (RA) has made significant progress over the past three decades. However, approximately 20-30% of patients remain resistant to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), and targeted synthetic DMARDs (tsDMARDs), presenting a major challenge in RA management. Telitacicept is a dual-target inhibitor of B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL). By inhibiting B cell maturation, differentiation, and antibody secretion by plasma cells, it reduces autoantibody production and the release of pro-inflammatory cytokines such as Tumor necrosis factor-α (TNF-α) and Interleukin-6 (IL-6), thereby alleviating joint inflammation. Clinically, a Phase III study of telitacicept in RA patients with inadequate response to methotrexate demonstrated a rapid onset of action within 4 weeks. At week 24, the ACR20 response rate in the 160 mg telitacicept group reached 67.4%, and at week 48, the response rate increased to 72.2%. Nearly 90% of patients exhibited no radiographic progression. In terms of safety, the incidence of adverse events with telitacicept was comparable to that of conventional therapies. Currently, there are no clinical trials or registered studies investigating the use of telitacicept in the treatment of refractory RA. This study aims to evaluate the efficacy and safety of telitacicept in patients with refractory rheumatoid arthritis.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DRUG	Telitacicept	Telitacicept 160mg qw subcutaneous injection

Timeline

• Start date: 2025-06-10
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2025-06-06
• Last updated: 2025-06-06

Locations

1 site across 1 country: China