RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

Assistance Publique - Hôpitaux de Paris20 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Wegener's Granulomatosis Churg-Strauss Syndrome Microscopic Polyangiitis

Interventions

InfliximabDRUG

Infliximab

RituximabDRUG

Rituximab

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Cochin

Paris, France

Outcomes

Primary Outcomes

Partial or complete remission of the vasculitides

Time frame: one year

Secondary Outcomes

To study the safety and adverse effects of both regimens

Time frame: one year

Microscopic polyangiitis

Time frame: one year

Wegener's granulomatosis

Time frame: one year

Churg-Strauss syndrome

Time frame: one year

Data from ClinicalTrials.gov

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