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Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis

NCT04871191 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-04-03

No results posted yet for this study

Summary

The purpose of this study is to identify the most promising therapeutic strategy for patients with granulomatosis with polyangiitis and inadequate response to standard of care therapy. It will evaluate the efficacy to induce remission of three different salvage strategies including: a combination of rituximab with addition of a conventional disease-modifying antirheumatic drugs (either methotrexate, azathioprine or mycophenolate mofetil, but preferentially methotrexate); tocilizumab; or tofacitinib.

Conditions

  • Granulomatosis With Polyangiitis
  • Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis

Interventions

DRUG

Rituximab

375 mg/m²/week for four consecutive weeks (Week 0, 1, 2 and 3) Maintenance rituximab at a fixed dose of 500 mg will be administered at week 24 and at week 52.

DRUG

Tocilizumab

Subcutaneous injection of 162 mg per week

DRUG

Tofacitinib

\- Tofacitinib, administered orally at a dose of 5 mg twice a day. Tofacitinib will start at week 0. Treatment will be continued until week 52

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Benjamin Terrier, MD, PhD · AP-HP - Service médecine interne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-06
Primary Completion
2028-10-31
Completion
2029-03-31

Countries

  • France

Study Locations

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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 NCT04871191 on ClinicalTrials.gov