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Maintenance of Remission With Rituximab Versus Azathioprine for Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis.

NCT03164473 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-11-20

No results posted yet for this study

Summary

The purpose of this study is to investigate, after achievement of remission, the efficacy of rituximab compared with azathioprine maintenance therapy on duration of remission, in patients with relapsing or newly-diagnosed Eosinophilic granulomatosis with polyangiitis EPGA receiving standard of care therapy including glucocorticoid therapy reduction/withdrawal.

Conditions

  • Eosinophilic Granulomatosis With Polyangiitis

Interventions

DRUG

Rituximab

pre-emptive 500-mg fixed-dose of IV rituximab every 6 months (total duration of 18 months = 4 infusions)

DRUG

Azathioprine

oral tablets : 2 mg/kg/day for 24 months

DRUG

Placebo-rituximab

4 infusions for 18 months

DRUG

Placebo-azathioprine

oral tablets for 24 months

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

  • Benjamin Terrier · National Referral Center for Rare Systemic Autoimmune Diseases - Hôpital Cochin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2024-09-23
Completion
2024-09-23

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 NCT03164473 on ClinicalTrials.gov