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

NCT ID: NCT05962840

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-29
• 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 investigate the remission rate of patients treated with Telitacicept combined with Rituximab in remission-induction and Telitacicept alone in remission-maintain treatment.

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 take Telitacicept as maintain treatment in AAV patients who receive Rituximab as remission-induction treatment, to verify the effectiveness of Telitacicept in maintenance therapy of AAV.

Objectives: To investigate the effectiveness of Telitacicept in reducing relapse rate by using from remission-induction treatment combined with Rituximab to maintenance treatment of AAV.

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

Conditions

ANCA Associated Vasculitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: PLACEBO_COMPARATOR

Placebo of Telitacicept

Intervention Type: OTHER

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

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)

Group Type: EXPERIMENTAL

Telitacicept

Intervention Type: DRUG

Patient will be treated with Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months

Interventions

Telitacicept

Patient will be treated with Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months

Intervention Type: DRUG

Placebo of Telitacicept

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

Intervention Type: OTHER

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 have severe active AAV according to the 2021 ACR/vasculitis foundation definition.

4. Patients have to be PR3-ANCA-positive at diagnosis or during the course of their disease.

Exclusion Criteria

1. Patients who had been treated with Rituximab but had to stop due to adverse events or intolerance.

2. Patients who had other autoimmune diseases.

3. 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).

4. Patients who are pregnant or have planned for pregnancy in next 2 years.

5. Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection.

6. Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection.

7. Patients with malignancy.

8. Patients who are not eligible according to the judge of the principal investigators.

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

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: collaborator

Chinese SLE Treatment And Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing Li, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Unione Mdecial College Hospital

Locations

Peking Union Medical College Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yunjiao Yang, MD

Role: CONTACT

yangyunjiao81@163.com

86-13671313079

Hanqi Wang, RN

Role: CONTACT

lijing6515@pumch.cn

86-15810927696

Facility Contacts

Yunjiao Yang, MD

Role: primary

yangyunjiao81@163.com

86-13671313079

Hanqi Wang, RN

Role: backup

lijing6515@pumch.cn

86-15810927696

Other Identifiers

CSTAR-K2956

Identifier Type: -

Identifier Source: org_study_id