RecruitingPhase 3NCT04871191

Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis

Salvage Therapy for Patients With Inadequate Response to Standard of Care Therapy in Granulomatosis With Polyangiitis


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

42 participants

Start Date

Jun 6, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Rituximab, a drug called Tocilizumab, and others for people with anti-neutrophil cytoplasmic antibody-associated vasculitis and granulomatosis with polyangiitis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRituximab

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.

DRUGTocilizumab

Subcutaneous injection of 162 mg per week

DRUGTofacitinib

\- 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


Locations(1)

Hôpital de la Croix Saint Simon

Paris, France

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NCT04871191


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