Antineutrophil cytoplasmic antibody (ANCA)- associated vasculitis (AAV)
Conditions
Brief summary
Part I induction treatment: The occurrence of complete remission (defined as BVAS/WG=0 disease activity) at 26 weeks after enrollment to Part I. Part II - Maintenance treatment: The occurrence of a positive treatment effect defined as complete remission (BVAS/WG=0 disease activity) or partial remission (BVAS/WG=1 or BVAS/WG=2) at 104 weeks after randomization to Part II.
Detailed description
Treatment response defined as a >50% reduction in BVAS/WG vasculitis activity from baseline at 26 weeks after enrollment in Part I., The occurrence of serious adverse events at 26 weeks after enrollment in Part I., The occurence of non-serious adverse events at 26 weeks after enrollment in Part I., The occurence of organ damage (based on VDI) at 26 weeks after enrollment in Part I., Change at 13 and 26 weeks after enrollment in Part I from baseline: a. ANCA autoantibody titre, b. CD19+ lymphocyte count, c. Concentration of C5a component of complement, d. Creatinine concentration, e. eGFR., The occurrence of a major relapse (defined as an increase in BVAS/WG score to ≥3 points, requiring reinitiation of remission-inducing treatment) at 26, 52, 78, and 104 weeks after randomization to Part II., The occurrence of a minor relapse (defined as an increase in BVAS/WG score to 1-2 points, requiring only an increase in maintenance glucocorticosteroid dose) at 26, 52, 78, and 104 weeks after randomization to Part II., The occurrence of serious adverse events at 26, 52, 78, and 104 weeks after randomization to Part II., The occurrence of non-serious adverse events at 26, 52, 78, and 104 weeks from randomization to Part II., The occurrence of organ damage (based on VDI) at 26, 52, 78, and 104 weeks after randomization to Part II., Change at 26, 52, 78, and 104 weeks after randomization to Part II from baseline: a. ANCA autoantibody titers, b. CD 19+ lymphocyte count, c. Concentration of C5a component of complement, d. Creatinine concentration, e. eGFR., Change at 26, 52, 78, and 104 weeks after randomization to Part II from baseline in quality of life as measured by the SF-36 form.
Interventions
Sponsors
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part I induction treatment: The occurrence of complete remission (defined as BVAS/WG=0 disease activity) at 26 weeks after enrollment to Part I. Part II - Maintenance treatment: The occurrence of a positive treatment effect defined as complete remission (BVAS/WG=0 disease activity) or partial remission (BVAS/WG=1 or BVAS/WG=2) at 104 weeks after randomization to Part II. | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment response defined as a >50% reduction in BVAS/WG vasculitis activity from baseline at 26 weeks after enrollment in Part I., The occurrence of serious adverse events at 26 weeks after enrollment in Part I., The occurence of non-serious adverse events at 26 weeks after enrollment in Part I., The occurence of organ damage (based on VDI) at 26 weeks after enrollment in Part I., Change at 13 and 26 weeks after enrollment in Part I from baseline: a. ANCA autoantibody titre, b. CD19+ lymphocyte count, c. Concentration of C5a component of complement, d. Creatinine concentration, e. eGFR., The occurrence of a major relapse (defined as an increase in BVAS/WG score to ≥3 points, requiring reinitiation of remission-inducing treatment) at 26, 52, 78, and 104 weeks after randomization to Part II., The occurrence of a minor relapse (defined as an increase in BVAS/WG score to 1-2 points, requiring only an increase in maintenance glucocorticosteroid dose) at 26, 52, 78, and 104 weeks after ran | — |
Countries
Poland
Outcome results
None listed