Clinical Trials Logo
  1. Home
  2. ANCA-associated Vasculitis
  3. NCT05962840

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

ANCA Associated Vasculitis Clinical Trial

Official title:
A Prospective, Randomized, Single-blinded Placebo-controlled, Single Center Clinical Study of the Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05962840
Study type Interventional
Source Chinese SLE Treatment And Research Group
Contact Yunjiao Yang, MD
Phone 86-13671313079
Email yangyunjiao81@163.com
Status Recruiting
Phase Phase 4
Start date June 29, 2023
Completion date December 31, 2026
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06462768 - Neutrophil Extracellular Traps in Different Forms of Systemic Sclerosis
Recruiting NCT03942887 - Exploring Durable Remission With Rituximab in Antineutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis Phase 3
Not yet recruiting NCT06420154 - The Safety and Efficacy of Anti-CD19 CAR-T Cells in Patients With Relapsed/Refractory Autoimmune Diseases Early Phase 1
Completed NCT04895878 - Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome
Completed NCT00293072 - Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Phase 2
Recruiting NCT04664465 - PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS
Recruiting NCT05315141 - Multicenter Cohort Study of AAV in Hunan of China
Terminated NCT05376319 - PR3-AAV Resilient Remission or PRRR Phase 2
Recruiting NCT04737343 - Comparison of the Efficacy of Leflunomide and Azathioprine for the Maintenance Therapy of ANCA Associated Vasculitis N/A
Suspended NCT03906227 - Tailoring Maintenance Therapy to Cluster of Differentiation 5 Positive (CD5+) Regulatory B Cell Recovery in ANCA Vasculitis N/A
Not yet recruiting NCT06152172 - CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101 Phase 1
Not yet recruiting NCT05946564 - A Trial to Evaluate the Efficacy of Pioglitazone to Promote Renal Tolerance in ANCA-associated Vasculitis - RENATO Trial Phase 3
Recruiting NCT04923074 - the Application of Diffusion Tensor Imaging in the Evaluation of Peripheral Neuropathy in ANCA Associated Vasculitis
Active, not recruiting NCT01633476 - CMV Modulation of the Immune System in ANCA-associated Vasculitis Phase 2
Not yet recruiting NCT05416723 - Occupational and Environmental Origins of ANCA Vasculitis: Contribution of Data From the National Network for Vigilance and Prevention of Occupational Pathologies (RNV3P)
Recruiting NCT06277427 - Refractory ANCA Associated Vasculitis and Lupus Nephritis Treated With BCMA-targeting CAR-T Cells N/A
Active, not recruiting NCT03967925 - Rituximab and Belimumab Combination Therapy in PR3 Vasculitis Phase 2
Recruiting NCT05630612 - ETA and AT1 Antagonism in ANCA-vasculitis (SPARVASC) Phase 2
Recruiting NCT04316494 - Hydroxychloroquine in ANCA Vasculitis Evaluation Phase 4
Recruiting NCT03698071 - Soluble CD95 Ligand Role in the Pathophysiology of Antineutrophil Cytoplasmic Antibody (ANCA) Associated Vasculitis N/A