Neuromyelitis Optica Spectrum Disorder (NMOSD)
Conditions
Brief summary
- The change from baseline in the annualized relapse rate (ARR) - Time to First Adjudicated On-trial Relapse (TFR)
Detailed description
Efficacy: - Change from baseline in expanded disability status scale (EDSS) score - Change from baseline in Hauser Ambulation Index (HAI) - The change from baseline in visual acuity at the end of the Primary Treatment Period, Efficacy: - The change from baseline in confrontational visual fields at the end of the Primary Treatment Period - The change from baseline in color vision at the end of the Primary Treatment Period, PK/PD: - Serum ravulizumab concentrations through the end of the Primary Treatment Period - Absolute values, change from baseline, and percentage change from baseline for free serum C5 concentrations over time through the end of the Primary Treatment Period, Health-related QoL: - Change from baseline in PedsQL Scales at the end of the Primary Treatment Period, Safety: - Incidence of AEs and SAEs - Change from baseline in vital signs, physical growth (weight, height, and head circumference [participants ≤ 3 years of age only]), and laboratory parameters at scheduled visits Extension treatment period: The endpoints of the Primary Treatment Period will be evaluated during the Extension Period.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - The change from baseline in the annualized relapse rate (ARR) - Time to First Adjudicated On-trial Relapse (TFR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: - Change from baseline in expanded disability status scale (EDSS) score - Change from baseline in Hauser Ambulation Index (HAI) - The change from baseline in visual acuity at the end of the Primary Treatment Period, Efficacy: - The change from baseline in confrontational visual fields at the end of the Primary Treatment Period - The change from baseline in color vision at the end of the Primary Treatment Period, PK/PD: - Serum ravulizumab concentrations through the end of the Primary Treatment Period - Absolute values, change from baseline, and percentage change from baseline for free serum C5 concentrations over time through the end of the Primary Treatment Period, Health-related QoL: - Change from baseline in PedsQL Scales at the end of the Primary Treatment Period, Safety: - Incidence of AEs and SAEs - Change from baseline in vital signs, physical growth (weight, height, and head circumference [participants ≤ 3 years of age only]), and laboratory parameters at scheduled vi | — |
Countries
France, Italy, Spain