NCT05605782Active, not recruiting
A Post-Authorization, Long-term Study of Ozanimod Real-world Safety
ORION (Ozanimod Real-World Safety - A Post- Authorisation Multi-National Long-term Non-Interventional Study)
Source: ClinicalTrials.gov · Last updated 26 Jun 2025
Brief summary (registry, in English)
The purpose of this study is to determine the rates of adverse events of interest (AEIs) in a real-world population of participants with relapsing remitting multiple sclerosis (RRMS) receiving Ozanimod, sphingosine-1 phosphate (S1P) receptor modulator, compared to the rates of these events in two population of participants: * Participants not exposed to ozanimod with RRMS who have received treatment with other S1P-receptor modulators disease modifying treatments (DMTs) * Participants not exposed to ozanimod with RRMS who have received treatment with other non-S1P-receptor modulators disease modifying treatments (DMTs)
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 9000 (actual)
- First submitted
- 31 Oct 2022
- Start date
- 2 Sept 2021
- Primary completion date
- 26 Jul 2033
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Multiple sclerosis
- NCT number
- NCT05605782
What you commit to
- Study type: Observational
- Participants enrolled: 9000
- From 2 Sept 2021 to the primary completion date, 26 Jul 2033
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants with dispensing/prescription of more than one cohort defining drug on the index date
- Other protocol-defined inclusion/exclusion criteria apply
Who the study is looking for
- Have a diagnosis of multiple sclerosis (MS) recorded on or before the index prescription
- Have at least 6 months of continuous enrollment in the data source (thereby providing medical and dispensing/prescription history data, along with an operational definition of new use) before the index date
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Evidera Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.