Actively Recruiting
Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-03
42
Participants Needed
1
Research Sites
194 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed or relapsing granulomatosis with polyangiitis meeting established criteria
- Age 18 years or older
- Active disease symptoms related to granulomatosis with polyangiitis
- Inadequate response to previous standard treatment with glucocorticoids plus cyclophosphamide and/or rituximab
- Disease progression despite 12 weeks of treatment, or less than 50% improvement in disease activity after 12 weeks, or persistent active disease requiring at least 7.5 mg/day prednisone equivalent after 12 weeks
- Stable oral glucocorticoid dose of 7.5 mg/day prednisone equivalent or higher in the 4 weeks before enrollment
- Stable dose of conventional disease-modifying anti-rheumatic drugs within 4 weeks before enrollment if currently treated
- Ability to understand study requirements and provide written informed consent
- Affiliation with social security system
You will not qualify if you...
- Allergy or hypersensitivity to monoclonal antibodies or study drugs (rituximab, abatacept, tocilizumab) or their ingredients
- Previous treatment with rituximab plus conventional DMARD, tofacitinib, or tocilizumab
- Contraindications to study treatments including ongoing infection, recent cancer within 5 years (except cured non-melanoma skin cancer), pregnancy, or breastfeeding
- Severe vasculitis needing plasma exchange or severe renal failure
- Vasculitis in remission or chronic inactive GPA symptoms
- Severe heart failure (NYHA class IV)
- Acute or chronic active infections including HIV, HBV, or HCV
- Active cancer or recent cancer within 5 years except certain controlled types
- Pregnant or breastfeeding women; women of childbearing potential must use effective contraception during and after treatment for specified durations
- Uncontrolled diseases or conditions interfering with participation, including substance abuse or severe psychiatric illness
- Participation in other investigational drug studies within 3 months
- Suspected poor treatment adherence
- Laboratory abnormalities: liver enzymes >5 times upper limit, platelet count below 100,000/mm3, or white blood cell count below 2000/mm3
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpital de la Croix Saint Simon
Paris, France, 75020
Actively Recruiting
Research Team
J
Jonathan London, MD
CONTACT
A
Alice CAMARA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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