Clinical Trials Logo
  1. Home
  2. ANCA-associated Vasculitis
  3. NCT04737343

Comparison of the Efficacy of Leflunomide and Azathioprine for the Maintenance Therapy of ANCA Associated Vasculitis — LEFAZAREM  

ANCA Associated Vasculitis Clinical Trial

Official title:
The Efficacy of Leflunomide for the Maintenance Therapy of ANCA Associated Vasculitis

Clinical Trial Summary

This study is a prospective, open-labelled, randomized, controlled,multi-center clincial trial. The aim of this study is to verify that the remission rate of patients treated with Leflunomide is not inferior to that of patients treated with Azathioprine.

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, Leflunomide (LEF) has not studied thoroughly yet. So far, only one study tested the efficacy of LEF in the maintenance therapy for AAV. However, the sample size of this study is small, so large size clinical study is needed to clarify the role of LEF in the maintenance of AAV. LEF is one of the most frequently prescribed DMARDs in the treatment of rheumatic diseases in China. It is cheap and widely available. Many experiences have been accumulated about its efficacy and safety 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 try to compare the effectiveness of LEF and AZA, the gold standard for maintenance therapy, in the maintenance of AAV. Objectives To verify that the effectiveness of LEF in reducing relapse is not inferior to AZA by comparing the relapse rate of LEF and AZA during the 18 month maintenance treatment of AAV. Study Design This is a prospective, randomized, open-label, control, non-inferiority study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04737343
Study type Interventional
Source Chinese SLE Treatment And Research Group
Contact Yunjiao Yang, MD
Phone 86-13671313079
Email yangyunjiao81@163.com
Status Recruiting
Phase N/A
Start date June 30, 2021
Completion date December 31, 2024
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 NCT05962840 - Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM) Phase 4
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