Clinical Trial: RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies
Brief Summary: 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.
Detailed Summary: 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).
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: Partial or complete remission of the vasculitides [ Time Frame: one year ]
Original Primary Outcome:
- Partial or complete remission of the vasculitides
- Microscopic Polyangiitis,
- Wegener’s granulomatosis
- SCHURG-STRAUSS syndrome
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: To study the safety and adverse effects of both regimens.
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: March 24, 2006
Date Started: May 2004
Date Completion:
Last Updated: November 16, 2007
Last Verified: March 2007
