Comparison of the Efficacy of Leflunomide and Azathioprine for the Maintenance Therapy of ANCA Associated Vasculitis
NCT ID: NCT04737343
Last Updated: 2021-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
114 participants
INTERVENTIONAL
2021-06-30
2024-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Azathioprine treatment arm
Patients will be treated with Azathioprine 100mg QD for 18 months combined with rednisone. The dosage of prednisone is tapered in the study period but will be maintained at 7.5mg/d to the end of the study period.All included patients will be treated with TMPco 2 tablets everyday during the study period if not contraindicated or intoleran.t
Azathioprine Tablets
Patients included into this study will be treated with Azathioprine tablets 100mg QD for 18 months.
Leflunomide treatment arm
Patient will be treated with Leflunomide 30mg QD for 18 months combined with prednisone. The dosage of prednisone is tapered in the study period but will be maintained at 7.5mg/d to the end of the study period. All included patients will be treated with TMPco 2 tablets everyday during the study period if not contraindicated or intolerant.
Leflunomide
Patient will be treated with Leflunomide(Tuoshu, the commericial name) 30mg QD for 18 months
Interventions
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Leflunomide
Patient will be treated with Leflunomide(Tuoshu, the commericial name) 30mg QD for 18 months
Azathioprine Tablets
Patients included into this study will be treated with Azathioprine tablets 100mg QD for 18 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Affiliated Hospital of Jilin University, Changchun,China
UNKNOWN
Second Affiliated Hospital of Nanchang University
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Beijing Shijitan Hospital, Capital Medical University
OTHER
The Affiliated Hospital of Inner Mongolia Medical University
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
Sichuan Province People's Hospital
UNKNOWN
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Chinese SLE Treatment And Research Group
OTHER
Responsible Party
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Xinping Tian
Professor of Medicine
Principal Investigators
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Xinping Tian
Role: PRINCIPAL_INVESTIGATOR
Peking Unione Mdecial College Hospital
Locations
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AnHui provincial hospital
Hefei, Anhui, China
the Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
the Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Li Wang, MD
Role: primary
Xiangpei Li, MD
Role: backup
Hongbin Li, MD
Role: primary
Ning Tie, MD
Role: backup
Jian Xu, MD
Role: primary
Shu Li, MD
Role: backup
Xinping Tian, MD
Role: primary
Hanqi Wang, RN
Role: backup
Other Identifiers
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CSTAR-006
Identifier Type: -
Identifier Source: org_study_id