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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Patient will be treated with Leflunomide(Tuoshu, the commericial name) 30mg QD for 18 months
Patients included into this study will be treated with Azathioprine tablets 100mg QD for 18 months.
AnHui provincial hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGthe Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
NOT_YET_RECRUITINGthe Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
NOT_YET_RECRUITINGthe percentage of patients with major relapse in 18 months follow-up time
the percentage of patients with major relapse (re-appearance or worsening of disease with a BVAS \>0 and involvement of at least one major organ, a life-threatening manifestation, or both) at month 18
Time frame: from inclusion to the end of the study, 18 months in total
The rate of minor relapse of the AZA and LEF treatment group in 18 months.
The rate of minor relapse (reappearance or worsening of disease with a BVAS \>0, not corresponding to a major relapse but requiring mild treatment intensification) of the AZA and LEF treatment group.
Time frame: from inclusion to the end of the study, 18 months in total
The rate of adverse events and their severity in both LEF and AZA treated patients during 18 months of the study period.
2\. The rate of adverse events and their severity(Severe events were defined as the adverse events of grade 3 or 4, deaths caused by any cause, cancers, side effects that necessitate hospitalization) in both LEF and AZA treated patients during the study period.
Time frame: from inclusion to the end of the study, 18 months in total
Patients progress to ESRD at the end of the study
Patients progress to ESRD at the end of the study
Time frame: from inclusion to the end of the study, 18 months in total
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Peking Union Medical College Hospital
Beijing, China
RECRUITING