RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

Not Applicable

Completed

• Conditions: Wegener's Granulomatosis; Churg-Strauss Syndrome; Microscopic Polyangiitis
• Interventions: Drug: Rituximab; Drug: Infliximab

• Registration Number: NCT00307593
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study Start: 2004-05
• Study First Submitted: 2006-03-24
• Study First Submitted QC: 2006-03-24
• Study First Posted: 2006-03-28
• Status Verified: 2007-03
• Study Completion: 2007-06
• Last Update Submitted: 2007-11-16
• Last Update Posted: 2007-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Rituximab	Rituximab
2	Infliximab	Infliximab

Primary Outcome Measures

Name	Time	Method
Partial or complete remission of the vasculitides	one year

Secondary Outcome Measures

Name	Time	Method
To study the safety and adverse effects of both regimens	one year
Microscopic polyangiitis	one year
Wegener's granulomatosis	one year
Churg-Strauss syndrome	one year

Trial Locations

Locations (1)

Hôpital Cochin; 🇫🇷 Paris, France