Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)

Sponsor
Chinese SLE Treatment And Research Group
Study ID
NCT05965284
Phase
PHASE4
Status
Recruiting
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Conditions

  • ANCA-associated Vasculitis
  • Maintenance Therapy

Eligibility Criteria

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

Interventions

  • Azathioprine — DRUG
    All patients included into this study will be treated with Azathioprine tablets 100mg QD for 12 months.
  • Telitacicept — DRUG
    Patient will be treated with Telitacicept (Taiai the commercial name) 160 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 compare the remission rate of patients treated with Telitacicept combined with azathioprine and azathioprine alone in remission-maintenance treatment of AAV.

Key Dates

Start date
Mar 9, 2023
Status verified
Jul 2023
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

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

Arms

  • Other: Azathioprine treatment arm
    Patients will be treated with Azathioprine 100mg per day for 12 months combined with prednisone no more than 10mg daily. The dosage of prednisone is tapered in the study period while sustained remission achieved. All included patients will be treated with TMPco 2 tablets per day during the study period if not contraindicated or intolerant.
  • Experimental: Telitacicept treatment arm
    Patients will be treated with Telitacicept 160mg per week combined with Azathioprine 100mg per day for 12 months combined with prednisone no more than 10mg daily. The dosage of prednisone is tapered in the study period while sustained remission achieved. All included patients will be treated with TMPco 2 tablets per day during the study period if not contraindicated or intolerant.

Primary Outcome Measure

The time of first relapse during 12 months follow-up of two groups [ Time Frame: from inclusion to the end of the study, 12 months in total ]

Central Contacts

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