RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

Condition(s) targeted: Wegener's Granulomatosis; Churg-Strauss Syndrome; Microscopic Polyangiitis

Intervention: Infliximab (Drug); Rituximab (Drug)

Phase: N/A

Status: Completed

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Loïc GUILLEVIN, MD, PhD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux 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 vasculitides.

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

Secondary outcome:

To study the safety and adverse effects of both regimens

Microscopic polyangiitis

Wegener's granulomatosis

Churg-Strauss syndrome

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).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Hôpital Cochin, Paris 75679, France

Starting date: May 2004
Ending date: June 2007
Last updated: November 16, 2007