RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides
Information source: Assistance Publique - H˘pitaux de Paris
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Wegener's Granulomatosis; Churg-Strauss Syndrome; Microscopic Polyangiitis
Intervention: Infliximab (Drug); Rituximab (Drug)
Sponsored by: Assistance Publique - H˘pitaux de Paris
Official(s) and/or principal investigator(s):
Lo├»c GUILLEVIN, MD, PhD, Principal Investigator, Affiliation: Assistance Publique - H├┤pitaux de Paris
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
Official title: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies
Study design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Primary outcome: Partial or complete remission of the vasculitides
To study the safety and adverse effects of both regimens
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).
Minimum age: 18 Years.
Maximum age: N/A.
- Systemic ANCA positive (+) vasculitides
- Relapsing or refractory vasculitides, resistant to corticosteroids and reference
- Age >18 years old
- Written informed consent
- Newly diagnosed patient
- Patient that had never received an immunosuppressant before to treat his/her
Locations and Contacts
H├┤pital Cochin, Paris 75679, France
Starting date: May 2004
Ending date: June 2007
Last updated: November 16, 2007