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

Chinese SLE Treatment And Research Group

Status and phase: Enrolling; Phase 4

Conditions: Maintenance Therapy; ANCA-associated Vasculitis

Treatments: Drug: Telitacicept; Drug: Azathioprine

Study type: Interventional

Funder types: Other

Identifiers

NCT05965284

CSTAR-K2374

Details and patient eligibility

About

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.

Full description

Background: The basic theme of AAV is relapse and remission. The maintenance therapy of AAV aimed to reduce or prevent relapse is very challenge. Although many medications have been used for the maintenance of AAV, Telitacicept (a BAFF/APRIL dual-target-inhibitor, which has been proved to be effect in treatment of SLE) has not been studied yet. One study tested the efficacy of Belimumab in the maintenance therapy for AAV. When taken Rituximab as remission-induction treatment, no relapse was observed. However, the sample size of this study is small, and the Belimumab, as a BAFF inhibitor, was not been proved to have effect on APRIL.

Many experiences have been accumulated about the efficacy and safety of Telitacicept in Chinese patients with rheumatic diseases. But there is no study to show its effectiveness in the reduction of the relapse of AAV in China. In this study, we add Telitacicept to azathioprine in maintain treatment in AAV patients who receive Rituximab as remission-induction treatment, to compare the relapse rates of Telitacicept combining azathioprine and azathioprine alone in maintenance therapy of AAV.

Objectives: To compare the relapse rates of Telitacicept combining azathioprine and azathioprine alone in maintenance treatment of AAV.

Study Design: This is a prospective, randomized, open-label, control, pilot study.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients age 18 to 65 years, both genders can be included.
2. 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.
3. 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).
4. Patients have to be ANCA-positive at diagnosis or during the course of their disease.

Exclusion criteria

1. Patients with TPMT gene mutation.
2. Patients who had been treated with either AZA but relapsed in the past.
3. Patients who had been treated with either AZA but had to stop due to adverse events or intolerance.
4. Patients who have planned for pregnancy in next 1.5 years.
5. Patients with severe liver dysfunction(defined as the 2-folds elevation of normal upper limit or Child grade III), heart failure or ESRD(eGFR<30ml/min).
6. Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection;
7. Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection;
8. Patients who had other autoimmune diseases.
9. Patients with malignancy.
10. Patients who are not eligible according to the judge of the principal investigators or site investigators.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Azathioprine treatment arm

Other group

Description:

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.

Treatment:

Drug: Azathioprine

Telitacicept treatment arm

Experimental group

Description:

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.

Treatment:

Drug: Azathioprine

Drug: Telitacicept