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

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.

Conditions

• ANCA Associated Vasculitis
• Maintenance Therapy

Interventions

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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Affiliated Hospital of Jilin University, Changchun,China

  collaborator UNKNOWN

• Second Affiliated Hospital of Nanchang University

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Beijing Shijitan Hospital, Capital Medical University

  collaborator OTHER

• The Affiliated Hospital of Inner Mongolia Medical University

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Sichuan Province People's Hospital

  collaborator UNKNOWN

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Chinese SLE Treatment And Research Group

  lead OTHER

Principal Investigators

• Xinping Tian · Peking Unione Mdecial College Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-30

Primary Completion

2024-11-30

Completion

2024-12-31

Countries

• China

Study Locations