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Rituximab in Eosinophilic Granulomatosis With Polyangiitis

NCT02807103 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2026-01-15

No results posted yet for this study

Summary

Phase III, comparative, multicenter, randomized, controlled, double-blind and superiority research, comparing rituximab-based regimen with conventional therapeutic strategy for the induction of remission in patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Patients with newly diagnosed or relapsing EGPA will be randomized in a 1:1 ratio to receive:

* Experimental therapeutic strategy based on the use of rituximab (experimental group)
* Conventional therapeutic strategy based on Five-Factor Score (FFS)-assessed disease severity (comparative group)

Conditions

  • Eosinophilic Granulomatosis With Polyangiitis (EGPA)

Interventions

DRUG

Rituximab

1 g intravenous pulse at day1 and day15

DRUG

Placebo-rituximab

intravenous pulses at day1 and day15

DRUG

Cyclophosphamide

intravenous 9 pulses : 600 mg/m2 at days 1, 15 and 29, and then 500 mg-fixed dose at days 50, 71, 92, 113, 134 and 155.

DRUG

Placebo-cyclophosphamide

intravenous 7 pulses : at days 29, 50, 71, 92, 113, 134 and 155.

Sponsors & Collaborators

  • French Vasculitis Study Group

    collaborator OTHER

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Xavier PUECHAL, MD, PhD · Centre de référence " Maladies systémiques et autoimmunes rares, en particulier Vascularites nécrosantes et Sclérodermies systémiques "

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-05
Primary Completion
2020-10-21
Completion
2020-10-21

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02807103 on ClinicalTrials.gov