granulomatosis with polyangiitis and microscopic polyangiitis
Conditions
Brief summary
The primary endpoint is survival without relapse in each arm after 24 months of follow-up. Relapse is defined as a BVAS >0.
Detailed description
1. Number of participants with a major or minor relapse during follow-, 2. Number of adverse events, 3. Number of serious adverse events: potentially fatal, requiring hospitalization, causing significant disability or leading to death, 4. Number of rituximab perfusions performed in both arms, 5. Sequalae according to the VDI classification during follow-up, 6. Quality of life according of HAQ and SF-36 classifications during follow-up, 7. Mortality in both arms, 8. The cumulative dose and duration of treatment with corticosteroids in both arms, 9. Changes in ANCA and B CD19+ cells rate in both arms and their correlation with clinical events
Interventions
DRUGRITUXIMAB
DRUGTruxima 500 mg concentrate for solution for infusion
DRUGPREDNISONE
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is survival without relapse in each arm after 24 months of follow-up. Relapse is defined as a BVAS >0. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of participants with a major or minor relapse during follow-, 2. Number of adverse events, 3. Number of serious adverse events: potentially fatal, requiring hospitalization, causing significant disability or leading to death, 4. Number of rituximab perfusions performed in both arms, 5. Sequalae according to the VDI classification during follow-up, 6. Quality of life according of HAQ and SF-36 classifications during follow-up, 7. Mortality in both arms, 8. The cumulative dose and duration of treatment with corticosteroids in both arms, 9. Changes in ANCA and B CD19+ cells rate in both arms and their correlation with clinical events | — |
Outcome results
None listed