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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00307593 |
The purpose of this study is to compare a 2 immunosuppressant regimen for the treatment of relapsing or refractory necrotizing antineutrophil cytoplasmic antibody (ANCA) associated vasculitides.
Condition | Intervention |
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Wegener's Granulomatosis Churg-Strauss Syndrome Microscopic Polyangiitis |
Drug: Infliximab Drug: Rituximab |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies |
Enrollment: | 20 |
Study Start Date: | May 2004 |
Study Completion Date: | June 2007 |
Arms | Assigned Interventions |
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1: Active Comparator
Rituximab
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Drug: Rituximab
Rituximab
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2: Active Comparator
Infliximab
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Drug: Infliximab
Infliximab
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The aim of this study is to compare the efficacy of rituximab versus infliximab in relapsing or refractory forms of ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | P020931, AOM02098 |
Study First Received: | March 24, 2006 |
Last Updated: | November 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00307593 History of Changes |
Health Authority: | France: Ministry of Health |
Systemic ANCA+ vascularizes Relapse Corticosteroids Immunosuppressant |
Infliximab/rituximab Patients with relapsing or refractory forms of ANCA associated vasculitides Microscopic polyangiitis |
Anti-Inflammatory Agents Lung Diseases, Interstitial Vasculitis Immunologic Factors Rituximab Infliximab Churg-Strauss Syndrome Vascular Diseases Granuloma Immunosuppressive Agents |
Microscopic Polyangiitis Lymphatic Diseases Wegener Granulomatosis Respiratory Tract Diseases Urologic Diseases Lung Diseases Wegener's Granulomatosis Kidney Diseases Antirheumatic Agents Lymphoproliferative Disorders |
Anti-Inflammatory Agents Immunologic Factors Churg-Strauss Syndrome Infliximab Antineoplastic Agents Physiological Effects of Drugs Pathologic Processes Respiratory Tract Diseases Urologic Diseases Syndrome Therapeutic Uses Cardiovascular Diseases Kidney Diseases Dermatologic Agents |
Lung Diseases, Interstitial Disease Vasculitis Rituximab Gastrointestinal Agents Vascular Diseases Granuloma Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Wegener Granulomatosis Lung Diseases Lymphoproliferative Disorders Antirheumatic Agents |