Patients with GPA and inadequate response to standard of care therapy defined as an inadequate response to either a combination of glucocorticoids plus cyclophosphamide AND/OR a combination of glucocorticoids plus rituximab.
Conditions
Brief summary
The primary endpoint will be the proportion of patients with a response or a remission at 12 weeks as defined according to the EULAR recommendations. Remission is defined as the absence of disease activity attributable to active disease qualified by the need for ongoing stable maintenance immunosuppressive therapy. The term ‘‘active disease’’ is not restricted to vasculitis only, but also includes other inflammatory features like granulomatous inflammation. Response is defined as a 50% reduction
Detailed description
Secondary endpoints: - The proportion of patients with a response or a remission according to the EULAR recommendations at week 24 and 52. - The difference between the physician’s and patient’s global assessment of disease activity between baseline and week 12 and between baseline and week 52. - The patient-reported outcomes (PRO) including: HAQ, SF-36 and VAA-PRO at week 12, 24 and 52-The number of adverse events, expressed as adverse events according to the CTCAE toxicity grading system pe
Interventions
DRUGRITUXIMAB
DRUGMETHOTREXATE
DRUGAZATHIOPRINE
DRUGMYCOPHENOLATE MOFETIL
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the proportion of patients with a response or a remission at 12 weeks as defined according to the EULAR recommendations. Remission is defined as the absence of disease activity attributable to active disease qualified by the need for ongoing stable maintenance immunosuppressive therapy. The term ‘‘active disease’’ is not restricted to vasculitis only, but also includes other inflammatory features like granulomatous inflammation. Response is defined as a 50% reduction | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - The proportion of patients with a response or a remission according to the EULAR recommendations at week 24 and 52. - The difference between the physician’s and patient’s global assessment of disease activity between baseline and week 12 and between baseline and week 52. - The patient-reported outcomes (PRO) including: HAQ, SF-36 and VAA-PRO at week 12, 24 and 52-The number of adverse events, expressed as adverse events according to the CTCAE toxicity grading system pe | — |
Countries
France
Outcome results
None listed