RecruitingPhase 3

Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis

France42 participantsStarted 2025-06-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. A combination of glucocorticoids plus cyclophosphamide
✓. AND /OR a combination of glucocorticoids plus rituximab
✓. A progressive disease unresponsive to previous standard of care therapy after 12 weeks of treatment
✓. Or a lack of response, defined as \< 50% reduction in the disease activity score, after 12 weeks of treatment
✓. Or a persistent active disease attributable to either a vasculitic or a granulomatous manifestation of GPA that requires the maintenance of corticosteroids ≥ 7.5 mg/day of equivalent prednisone after ≥ 12 weeks of treatment.

Exclusion criteria

✕. aspartate or alanine aminotransferase (AST/SGOT or ALT/SGPT) \> 5 times upper limit of normal
✕. Platelet count \<100.000/mm3
✕. White blood cell count \<2000/mm3

What they're measuring

Proportion of patients with a response or a remission

Timeframe: week 12

Trial details

NCT IDNCT04871191

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-10

Contact for this trial

Jonathan London, MD

+33 1 44 64 16 02 jlondon@hopital-dcss.org

View on ClinicalTrials.gov More Granulomatosis With Polyangiitis trials