RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

November 16, 2007 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75679
        • Hôpital COCHIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Partial or complete remission of the vasculitides
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
To study the safety and adverse effects of both regimens
Time Frame: one year
one year
Microscopic polyangiitis
Time Frame: one year
one year
Wegener's granulomatosis
Time Frame: one year
one year
Churg-Strauss syndrome
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Loic Guillevin, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

March 24, 2006

First Submitted That Met QC Criteria

March 24, 2006

First Posted (Estimate)

March 28, 2006

Study Record Updates

Last Update Posted (Estimate)

November 19, 2007

Last Update Submitted That Met QC Criteria

November 16, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P020931
  • AOM02098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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