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Sponsored by: |
Hospices Civils de Lyon |
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Information provided by: | Hospices Civils de Lyon |
ClinicalTrials.gov Identifier: | NCT00349674 |
Remission of ANCA-associated vasculitis can be obtained in approximately 80% of the patients with a combination of corticosteroids and cyclophosphamide. However, relapses are frequent. This point warrants the prescription of a maintenance treatment with a less toxic immunosuppressant for several months to years. The optimal drug in this indication is not determine. We decided therefore to compare the 2 most used drugs in this indication. Induction therapy consists in the combination of corticosteroids and intravenous cyclophosphamide pulses. Corticotherapy consisted first in one daily methylprednisolone pulse, for 1 to 3 days, followed by oral prednisolone at the dose of 1 mg/kg/d for 3 weeks, then progressively tapered and stopped at the 18th month from the diagnosis. Cyclophosphamide is administered every 2 weeks for the first 3 bolus (0.6 g/m2 - D1, 15 and 30), then every 3 weeks (0.7 g/m2). Once remission is achieved, patients receive 3 additional bolus (0.7 g/m2). At that time, patients are randomized for a maintenance treatment with azathioprine (2 mg/kg/d, orally) or oral methotrexate (starting at the dose of 0.3 mg/kg/wk, then progressively increased every weeks by 2.5mg, if necessary, to a maximum and optimal dose of 25 mg/wk) for 12 months.
Condition | Intervention | Phase |
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Systemic Wegener's Granulomatosis |
Drug: Azathioprine: 2 mg/kg/day Drug: methotrexate 0.3 mg/kg/week, to a maximum and optimal dose of 25 mg/week |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Treatment of ANCA-Associated Vasculitides : Corticosteroids and Pulse Cyclophosphamide Followed by Maintenance Therapy With Methotrexate or Azathioprine: a Prospective Multicenter Randomized Trial |
Estimated Enrollment: | 126 |
Study Start Date: | January 1999 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 97.129 |
Study First Received: | July 6, 2006 |
Last Updated: | October 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00349674 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Wegener's granulomatosis, microscopic polyangiitis, ANCA-associated vasculitis, methotrexate, azathioprine |
Lung Diseases, Interstitial Microscopic polyangiitis Vasculitis Vascular Diseases Wegener's granulomatosis Cyclophosphamide Folic Acid |
Azathioprine Wegener Granulomatosis Respiratory Tract Diseases Urologic Diseases Lung Diseases Methotrexate Kidney Diseases |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents Folic Acid Antagonists |
Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Abortifacient Agents Cardiovascular Diseases Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |