Multiple Sclerosis in pediatric patients
Conditions
Brief summary
Annualized relapse rate (ARR of confirmed relapses)
Detailed description
Annualized relapse rate (ARR of confirmed relapses), Number of new or newly enlarging T2 lesions on MRI per year (annualized T2 lesion rate), Neurofilament light chain (NfL) concentration in serum, Ofatumumab and siponimod and (metabolite M17) plasma concentrations, Proportion of participants with anti-ofatumumab antibodies, Adverse events, Columbia Suicide Severity Rating Scale (C-SSRS), ECG, laboratory and ophthalmological data, pulmonary function tests and vital signs
Interventions
DRUGPlacebo to Siponimod (BAF312) [Mayzent] film-coated tablets
DRUGPlacebo to Fingolimod (FTY720) [Gilenya] 0.25mg & 0.5mg
DRUGOFATUMUMAB
DRUGBAF312
DRUGPlacebo to Ofatumumab (OMB157) [Kesimpta]
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized relapse rate (ARR of confirmed relapses) | — |
Secondary
| Measure | Time frame |
|---|---|
| Annualized relapse rate (ARR of confirmed relapses), Number of new or newly enlarging T2 lesions on MRI per year (annualized T2 lesion rate), Neurofilament light chain (NfL) concentration in serum, Ofatumumab and siponimod and (metabolite M17) plasma concentrations, Proportion of participants with anti-ofatumumab antibodies, Adverse events, Columbia Suicide Severity Rating Scale (C-SSRS), ECG, laboratory and ophthalmological data, pulmonary function tests and vital signs | — |
Countries
Austria, Belgium, Croatia, Estonia, France, Germany, Italy, Latvia, Poland, Portugal, Romania, Slovakia, Spain
Outcome results
None listed