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

NCT ID: NCT05965284

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-09
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed 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.

Conditions

ANCA-associated Vasculitis; Maintenance Therapy

Keywords

ANCA-associated Vasculitis; Telitacicept; Azathioprine; Relapse rate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Azathioprine

Intervention Type: DRUG

All patients included into this study will be treated with Azathioprine tablets 100mg QD for 12 months.

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.

Group Type: EXPERIMENTAL

Azathioprine

Intervention Type: DRUG

All patients included into this study will be treated with Azathioprine tablets 100mg QD for 12 months.

Telitacicept

Intervention Type: DRUG

Patient will be treated with Telitacicept (Taiai the commercial name) 160 mg every week subcutaneously for 12 months

Interventions

Azathioprine

All patients included into this study will be treated with Azathioprine tablets 100mg QD for 12 months.

Intervention Type: DRUG

Telitacicept

Patient will be treated with Telitacicept (Taiai the commercial name) 160 mg every week subcutaneously for 12 months

Intervention Type: DRUG

Other Intervention Names

Taiai for commercial name

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese SLE Treatment And Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JIng Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Unione Mdecial College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yunjiao Yang, M.D.

Role: CONTACT

Phone: +86-13671313079

Email: yangyunjiao81@163.com

Facility Contacts

Yunjiao Yang, M.D.

Role: primary

Hanqi Wang, RN

Role: backup

Other Identifiers

CSTAR-K2374

Identifier Type: -

Identifier Source: org_study_id