Status:
UNKNOWN
Comparison of the Efficacy of Leflunomide and Azathioprine for the Maintenance Therapy of ANCA Associated Vasculitis
Lead Sponsor:
Chinese SLE Treatment And Research Group
Collaborating Sponsors:
Shanghai Zhongshan Hospital
Affiliated Hospital of Jilin University, Changchun,China
Conditions:
ANCA Associated Vasculitis
Maintenance Therapy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 i...
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 mainte...
Eligibility Criteria
Inclusion
- Patients age 18 to 75 years, both genders can be included.
- 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.
- Patients must fulfill the 1990 ACR classification criteria of GPA, EGPA and 2012 modified Chapel Hill classification criteria of MPA.
- Patients have to be ANCA-positive at diagnosis or during the course of their disease.
- Patients must sign the informed consent.
Exclusion
- Patients with TPMT gene mutation；
- Patients who had been treated with either AZA or LEF but relapsed in the past;
- Patients who had been treated with either AZA or LEF but had to stop due to adverse events or intolerance;
- Patients who have planned for pregnancy in next 2 years;
- Patients with severe liver dysfunction(defined as the elevation of liver enzyme 3 times the upper limit or Child grade III) or ESRD；
- Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection;
- Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection;
- Patients who are not eligible according to the judge of the principal investigators or site investigators.
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04737343
Start Date
June 30 2021
End Date
December 31 2024
Last Update
November 30 2021
Active Locations (4)
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1
AnHui provincial hospital
Hefei, Anhui, China
2
the Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China, 010050
3
the Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
4
Peking Union Medical College Hospital
Beijing, China, 100032