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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.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00307593
Date of registration: 24/03/2006
Prospective Registration: No
Primary sponsor: Assistance Publique - Hôpitaux de Paris
Public title: RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides
Scientific title: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies
Date of first enrolment: May 2004
Target sample size: 20
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00307593
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Loïc GUILLEVIN, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Assistance Publique - Hôpitaux de Paris
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Churg-Strauss Syndrome
Microscopic Polyangiitis
Wegener's Granulomatosis
Intervention(s)
Drug: Infliximab
Drug: Rituximab
Primary Outcome(s)
Partial or complete remission of the vasculitides [Time Frame: one year]
Secondary Outcome(s)
Churg-Strauss syndrome [Time Frame: one year]
Microscopic polyangiitis [Time Frame: one year]
To study the safety and adverse effects of both regimens [Time Frame: one year]
Wegener's granulomatosis [Time Frame: one year]
Secondary ID(s)
AOM02098
P020931
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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