Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT04871191
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    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.
  • Tocilizumab — DRUG
    Subcutaneous injection of 162 mg per week
  • Tofacitinib — DRUG
    \- 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

Study Details

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.

Key Dates

Start date
Jun 6, 2025
Status verified
Mar 2026
Primary completion
Oct 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rituximab + cDMARD
    Rituximab will be administered at 375 mg/m²/week for four consecutive weeks. Maintenance rituximab at a fixed dose of 500 mg will be administered at week 24 and at week 52. The choice of the cDMARD will be left to the treating clinician and will include either methotrexate, azathioprine or mycophenolate mofetil, but the choice will be preferably methotrexate. Methotrexate will be administered orally or subcutaneously at 0.3 mg/kg/week, azathioprine orally at 2-3 mg/kg/d and mycophenolate mofetil orally at 2-3 g/d.
  • Experimental: Tocilizumab
    Tocilizumab will be administered subcutaneously every week at a fixed dose of 162 mg per week.
  • Experimental: Tofacitinib
    Tofacitinib will be administered orally at 5 mg twice daily. Tofacitinib will start at week 0. Treatment will continue until week 52.

Primary Outcome Measure

Proportion of patients with a response or a remission [ Time Frame: week 12 ]

Central Contacts

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