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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00307593 |
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Date of registration:
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24/03/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides
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Scientific title:
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Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies |
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Date of first enrolment:
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May 2004 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00307593 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Loïc GUILLEVIN, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Churg-Strauss Syndrome
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Microscopic Polyangiitis
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Wegener's Granulomatosis
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Intervention(s)
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Drug: Infliximab
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Drug: Rituximab
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Primary Outcome(s)
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Partial or complete remission of the vasculitides
[Time Frame: one year]
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Secondary Outcome(s)
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Churg-Strauss syndrome
[Time Frame: one year]
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Microscopic polyangiitis
[Time Frame: one year]
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To study the safety and adverse effects of both regimens
[Time Frame: one year]
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Wegener's granulomatosis
[Time Frame: one year]
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Secondary ID(s)
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P020931
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AOM02098
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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