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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChinese SLE Treatment And Research Group

About this trial

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.

Eligibility criteria

Qualifiers

Patients age 18 to 65 years, both genders can be included.

Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis must fulfill the 2022 ACR/EULAR classification criteria of GPA or MPA.

Patients who are in complete remission after combined treatment with glucocorticoids and Rituximab. Remission is defined as a Birmingham Vasculitis Activity Score (BVAS version 3) of 0. And the daily dosage of prednisone are no more than 10mg (or equivalent).

Patients have to be ANCA-positive at diagnosis or during the course of their disease.

Disqualifiers

Patients with TPMT gene mutation.

Patients who had been treated with either AZA but relapsed in the past.

Patients who had been treated with either AZA but had to stop due to adverse events or intolerance.

Patients who have planned for pregnancy in next 1.5 years.

Trial design

Treatments tested in this trial

  • Azathioprine
  • Telitacicept

Treatment groups

40 Participants
are divided into 2 treatment groups