RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT00307593
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wegener's Granulomatosis; Churg-Strauss Syndrome; Microscopic Polyangiitis	Drug: Infliximab; Drug: Rituximab	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies
• Study Start Date: May 1, 2004
• Actual Study Completion Date: Jun 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Rituximab	Drug: Rituximab; Rituximab
Active Comparator: 2 Infliximab	Drug: Infliximab; Infliximab

Outcome Measures

Primary Outcome Measures

1. Partial or complete remission of the vasculitides [one year]

Secondary Outcome Measures

1. To study the safety and adverse effects of both regimens [one year]

2. Microscopic polyangiitis [one year]

3. Wegener's granulomatosis [one year]

4. Churg-Strauss syndrome [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Cochin	Paris		France	75679

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Loïc GUILLEVIN, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00307593
• Other Study ID Numbers: P020931; AOM02098
• First Posted: Mar 28, 2006
• Last Update Posted: Nov 19, 2007
• Last Verified: Mar 1, 2007

• Keywords provided by , ,: Systemic ANCA+ vascularizes; Relapse; Corticosteroids; Immunosuppressant; Infliximab/rituximab; Patients with relapsing or refractory forms of ANCA; associated vasculitides Microscopic polyangiitis
• Additional relevant MeSH terms: Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Vasculitis; Systemic Vasculitis; Churg-Strauss Syndrome; Rituximab; Infliximab

Study Results

No Results Posted as of Nov 19, 2007