Relapsing Remitting Multiple Sclerosis
Conditions
Brief summary
Core phase: To assess rate of Multiple Sclerosis (MS) relapse over 2 years
Detailed description
Core and Extension Phase: proportion of the participants who have worsening or improving RRMS, Core and Extension Phase: occurrence of adverse events (type, severity and relationship to the study drug), Core and Extension Phase: early study discontinuation, Core and Extension Phase: measurements of the amount of ozanimod in a participant’s body
Interventions
DRUGFINGOLIMOD
DRUGOzanimod HCl 0.23 mg
DRUGOzanimod HCl 1 mg
DRUGOzanimod HCl 0.0575 mg
DRUGOzanimod HCl 0.25 mg
DRUGOzanimod HCl
DRUGFingolimod 0.25 mg capsule
DRUGFingolimod 0.5 mg capsule
Sponsors
Bristol-Myers Squibb Services Unlimited Company
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Core phase: To assess rate of Multiple Sclerosis (MS) relapse over 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Core and Extension Phase: proportion of the participants who have worsening or improving RRMS, Core and Extension Phase: occurrence of adverse events (type, severity and relationship to the study drug), Core and Extension Phase: early study discontinuation, Core and Extension Phase: measurements of the amount of ozanimod in a participant’s body | — |
Countries
Italy, Poland, Portugal, Romania, Spain
Outcome results
None listed