Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM)

Sponsor
Chinese SLE Treatment And Research Group
Study ID
NCT05962840
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • ANCA Associated Vasculitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Telitacicept — DRUG
    Patient will be treated with Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months
  • Placebo of Telitacicept — OTHER
    Patient will be treated with placebo of Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months

Study Details

This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to investigate the remission rate of patients treated with Telitacicept combined with Rituximab in remission-induction and Telitacicept alone in remission-maintain treatment.

Key Dates

Start date
Jun 29, 2023
Status verified
Jul 2023
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Placebo Comparator: Placebo arm
    Patients with active AAV will be treated with Rituximab and glucocorticoid to induce remission. And the placebo of Telitacicept would be given 80 mg every week subcutaneously for 12 months. Glucocorticoid would be tapered as recommended by 2022 EULAR AAV recommendation (as protocol of PEXIVAS study)
  • Experimental: Telitacicept treatment arm
    Patients with active AAV will be treated with Rituximab and glucocorticoid to induce remission. And the Telitacicept would be given 80 mg every week subcutaneously for 12 months. Glucocorticoid would be tapered as recommended by 2022 EULAR AAV recommendation (as protocol of PEXIVAS study)

Primary Outcome Measure

The time of first relapse during 24 months follow-up of two groups [ Time Frame: from inclusion to the end of the study, 24 months in total ]

Central Contacts