Cryoglobulinemia vasculitis
Conditions
Brief summary
Complete clinical response rate of vasculitis symptoms at week (W) 25 with oral corticosteroid withdrawal (prednisone (or prednisolone, only if prednisone is out of stock in the market) at 0 mg/day) at week (W) 12.
Detailed description
•Safety and tolerability of treatments as assessed by frequency and severity of adverse clinical events at W25 and at W48 •Complete, partial and non-clinical response rate at W13, W25 and at W48. •Complete renal response rate at W13, W25 and W48 • Rate of cryoglobulinemia clearance, of negativation of rheumatoid factor activity and of normalization of C4 complement level at W13, W25 and at W48 •Rate of early failures (non clinical response at W5)
Interventions
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete clinical response rate of vasculitis symptoms at week (W) 25 with oral corticosteroid withdrawal (prednisone (or prednisolone, only if prednisone is out of stock in the market) at 0 mg/day) at week (W) 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| •Safety and tolerability of treatments as assessed by frequency and severity of adverse clinical events at W25 and at W48 •Complete, partial and non-clinical response rate at W13, W25 and at W48. •Complete renal response rate at W13, W25 and W48 • Rate of cryoglobulinemia clearance, of negativation of rheumatoid factor activity and of normalization of C4 complement level at W13, W25 and at W48 •Rate of early failures (non clinical response at W5) | — |
Countries
France
Outcome results
None listed