RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

Microscopic Polyangiitis Clinical Trial

Official title:

Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307593
• Other study ID #: P020931
• Secondary ID: AOM02098
• Status: Completed
• Phase: N/A
• First received: March 24, 2006
• Last updated: November 16, 2007
• Start date: May 2004
• Est. completion date: June 2007

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Churg-Strauss Syndrome
• Microscopic Polyangiitis
• Systemic Vasculitis
• Vasculitis
• Wegener Granulomatosis
• Wegener's Granulomatosis

Intervention

Drug:
• Infliximab
Infliximab
• Rituximab
Rituximab

Locations

Country	Name	City	State
France	Hôpital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partial or complete remission of the vasculitides		one year
Secondary	To study the safety and adverse effects of both regimens		one year
Secondary	Microscopic polyangiitis		one year
Secondary	Wegener's granulomatosis		one year
Secondary	Churg-Strauss syndrome		one year