Brief Title
RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides
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 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).
Study Type
Interventional
Primary Outcome
Partial or complete remission of the vasculitides
Secondary Outcome
To study the safety and adverse effects of both regimens
Condition
Wegener's Granulomatosis
Intervention
Infliximab
Study Arms / Comparison Groups
1
Description: Rituximab
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
20
Start Date
May 2004
Completion Date
June 2007
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Loïc GUILLEVIN, MD, PhD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00307593
Organization ID
P020931
Secondary IDs
AOM02098
Study Sponsor
Assistance Publique - Hôpitaux de Paris
Study Sponsor
Loïc GUILLEVIN, MD, PhD, Principal Investigator, Assistance Publique - Hôpitaux de Paris
Verification Date
March 2007