Efficacy and Safety of Telitacicept in the Treatment of Refractory Rheumatoid Arthritis

Sponsor
Peking University People's Hospital
Study ID
NCT07796516
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Telitacicept 160mg — BIOLOGICAL
    Telitacicept 160 mg will be administered subcutaneously once weekly for 24 consecutive weeks.
  • Standard therapy — DRUG
    Standard therapy includes DMARDs, GCs, and NSAIDs.

Study Details

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.

Key Dates

First listed
Sep 1, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Dec 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Telitacicept plus standard therapy group
  • Active Comparator: Standard therapy group
    Standard therapy includes disease-modifying antirheumatic drugs (DMARDs), glucocorticoids and non-steroidal anti-inflammatory drugs.

Primary Outcome Measure

ACR20 response rate [ Time Frame: Week 24 ]

Central Contacts

Find similar trials

Nationwide
Rheumatoid arthritis trialsRheumatology trialsAutoimmune disease trialsMusculoskeletal disorders trials

Related Studies