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RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

NCT ID: NCT00307593

Last Updated: 2007-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2007-06-30

Brief Summary

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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

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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).

Conditions

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Wegener's Granulomatosis Churg-Strauss Syndrome Microscopic Polyangiitis

Keywords

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Systemic ANCA+ vascularizes Relapse Corticosteroids Immunosuppressant Infliximab/rituximab Patients with relapsing or refractory forms of ANCA associated vasculitides Microscopic polyangiitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Rituximab

Group Type ACTIVE_COMPARATOR

Rituximab

Intervention Type DRUG

Rituximab

2

Infliximab

Group Type ACTIVE_COMPARATOR

Infliximab

Intervention Type DRUG

Infliximab

Interventions

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Infliximab

Infliximab

Intervention Type DRUG

Rituximab

Rituximab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Principal Investigators

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Loïc GUILLEVIN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital Cochin

Paris, , France

Site Status

Countries

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France

Other Identifiers

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AOM02098

Identifier Type: -

Identifier Source: secondary_id

P020931

Identifier Type: -

Identifier Source: org_study_id