RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

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Wegener’s Granulomatosis
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Brief Title

RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

Official Title

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

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 Type

Interventional

Primary Outcome

Partial or complete remission of the vasculitides

Secondary Outcome

 To study the safety and adverse effects of both regimens

Condition

Wegener's Granulomatosis

Intervention

Infliximab

Study Arms / Comparison Groups

 1
Description:  Rituximab

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

20

Start Date

May 2004

Completion Date

June 2007

Eligibility 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Loïc GUILLEVIN, MD, PhD, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT00307593

Organization ID

P020931

Secondary IDs

AOM02098

Study Sponsor

Assistance Publique - Hôpitaux de Paris

Study Sponsor

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

Verification Date

March 2007