RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides
This study has been completed.
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00307593
First received: March 24, 2006
Last updated: November 16, 2007
Last verified: March 2007
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Purpose
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 |
|---|---|
|
Wegener's Granulomatosis Churg-Strauss Syndrome Microscopic Polyangiitis |
Drug: Infliximab Drug: Rituximab |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- Partial or complete remission of the vasculitides [ Time Frame: one year ]
Secondary Outcome Measures:
- To study the safety and adverse effects of both regimens [ Time Frame: one year ]
- Microscopic polyangiitis [ Time Frame: one year ]
- Wegener's granulomatosis [ Time Frame: one year ]
- Churg-Strauss syndrome [ Time Frame: one year ]
| Enrollment: | 20 |
| Study Start Date: | May 2004 |
| Study Completion Date: | June 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Rituximab
|
Drug: Rituximab
Rituximab
Other Name: Rituximab
|
|
Active Comparator: 2
Infliximab
|
Drug: Infliximab
Infliximab
Other Name: Infliximab
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Systemic ANCA positive (+) vasculitides
- Relapsing or refractory vasculitides, resistant to corticosteroids and reference immunosuppressant therapies
- Age >18 years old
- Written informed consent
Exclusion Criteria:
- Newly diagnosed patient
- Patient that had never received an immunosuppressant before to treat his/her vasculitis
- Malignancy
- Pregnancy
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00307593 History of Changes |
| Other Study ID Numbers: | P020931, AOM02098 |
| Study First Received: | March 24, 2006 |
| Last Updated: | November 16, 2007 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Systemic ANCA+ vascularizes Relapse Corticosteroids Immunosuppressant |
Infliximab/rituximab Patients with relapsing or refractory forms of ANCA associated vasculitides Microscopic polyangiitis |
Additional relevant MeSH terms:
|
Churg-Strauss Syndrome Vasculitis Wegener Granulomatosis Systemic Vasculitis Microscopic Polyangiitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Vascular Diseases Cardiovascular Diseases Granuloma Lymphoproliferative Disorders Lymphatic Diseases Autoimmune Diseases Immune System Diseases Lung Diseases, Interstitial |
Lung Diseases Respiratory Tract Diseases Immunosuppressive Agents Rituximab Infliximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents Dermatologic Agents Gastrointestinal Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 18, 2013