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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese SLE Treatment And Research Group
• Collaborators: Affiliated Hospital of Jilin University, Changchun,China; Beijing Shijitan Hospital; Beijing Shijitan Hospital, Capital Medical University; Second Affiliated Hospital of Nanchang University; Second Affiliated Hospital, School of Medicine, Zhejiang University; Shanghai Zhongshan Hospital; Sichuan Province People's Hospital; The Affiliated Hospital of Inner Mongolia Medical University; The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Kunming Medical College
• Treatments: Azathioprine; Leflunomide

Criteria

Inclusion Criteria:

1. Patients age 18 to 75 years, both genders can be included.

2. Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis, microscopic polyangiitis, or EGPA in complete remission after combined treatment with glucocorticoids and pulse cyclophosphamide or Rituximab. Remission is defined as a Birmingham Vasculitis Activity Score(BVAS version 3) of 0.

3. Patients must fulfill the 1990 ACR classification criteria of GPA, EGPA and 2012 modified Chapel Hill classification criteria of MPA.

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

5. Patients must sign the informed consent.

Exclusion Criteria:

1. Patients with TPMT gene mutation；

2. Patients who had been treated with either AZA or LEF but relapsed in the past;

3. Patients who had been treated with either AZA or LEF but had to stop due to adverse events or intolerance;

4. Patients who have planned for pregnancy in next 2 years;

5. Patients with severe liver dysfunction(defined as the elevation of liver enzyme 3 times the upper limit or Child grade III) or ESRD；

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

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

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