NCT04737343

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

The Efficacy of Leflunomide for the Maintenance Therapy of ANCA Associated Vasculitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Chinese SLE Treatment And Research Group · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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, 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.

Conditions

• ANCA Associated Vasculitis
• Maintenance Therapy

Interventions

Type	Name	Description
DRUG	Leflunomide	Patient will be treated with Leflunomide(Tuoshu, the commericial name) 30mg QD for 18 months
DRUG	Azathioprine Tablets	Patients included into this study will be treated with Azathioprine tablets 100mg QD for 18 months.

Timeline

• Start date: 2021-06-30
• Primary completion: 2024-11-30
• Completion: 2024-12-31
• First posted: 2021-02-03
• Last updated: 2021-11-30

Locations

4 sites across 1 country: China