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 study is investigating "Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis". Researchers are looking for volunteers to help improve understanding and treatments in this area. You may be eligible if: - You are at least 18 Years - Aged 18 years or older - Active clinical manifestations attributable to GPA - An inadequate response to previous standard of care therapy including either : - A combination of glucocorticoids plus cyclophosphamide - AND /OR a combination of glucocorticoids plus rituximab You may NOT be eligible if: - An allergy or hypersensitivity to monoclonal antibodies or either of the study drugs (rituximab, abatacept or tocilizumab) or to their excipients - A previous treatment with a combination of rituximab plus a cDMARD, with tofacitinib, or with tocilizumab - Patients with vasculitis in remission - Patients with symptoms attributable to chronic and non-active GPA - Patients with severe cardiac failure defined as class IV in New York Heart Association - Patients with acute infections or chronic active infections (including HIV, HBV or HCV) Talk to your doctor to see if this trial is right for you.

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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