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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| Affiliated Hospital of Jilin University, Changchun,China | UNKNOWN |
| Second Affiliated Hospital of Nanchang University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azathioprine treatment arm | Active Comparator | 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 |
|
| Leflunomide treatment arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leflunomide | Drug | Patient will be treated with Leflunomide(Tuoshu, the commericial name) 30mg QD for 18 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| the 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 | from inclusion to the end of the study, 18 months in total |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from inclusion to the end of the study, 18 months in total |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunjiao Yang, MD | Contact | 86-13671313079 | 8613671313079 | yangyunjiao81@163.com |
| Hanqi Wang, RN | Contact | 86-15810927696 | 8613691165939 | tianxp6@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xinping Tian | Peking Unione Mdecial College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AnHui provincial hospital | Not yet recruiting | Hefei | Anhui | China |
only patient clincial information coud be released to public
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| 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 |
prospective, randomized, open-label, control, non-inferiority study
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| Azathioprine Tablets | Drug | Patients included into this study will be treated with Azathioprine tablets 100mg QD for 18 months. |
|
| 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. |
| 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 | from inclusion to the end of the study, 18 months in total |
| the Affiliated Hospital of Inner Mongolia Medical University | Not yet recruiting | Hohhot | Inner Mongolia | 010050 | China |
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| the Affiliated Hospital of Kunming Medical University | Not yet recruiting | Kunming | Yunnan | 650032 | China |
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| Peking Union Medical College Hospital | Recruiting | Beijing | 100032 | China |
|
| ID | Term |
|---|---|
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| ID | Term |
|---|---|
| D056647 | Systemic Vasculitis |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077339 | Leflunomide |
| D001379 | Azathioprine |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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