Ozanimod Real-World Safety - A Post-Authorisation Multi-National Long-term Non-Interventional Study (ORION)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48378
• EU PAS number:
  EUPAS44615
• Study ID:
  48378
• Official title and acronym:
  Ozanimod Real-World Safety - A Post-Authorisation Multi-National Long-term Non-Interventional Study (ORION)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  United States
• Study description:
  This is a long-term observational study including patients exposed to ozanimod or other medications used to treat MS. The primary endpoints of interest are MACE (composite and the individual components of MACE), SOI, SALI, macular edema, and malignancy. The study will estimate the incidence rates of these events in one exposed (ozanimod) cohort, and two comparator cohorts, defined by DMTs for MS. Hazards ratios will be considered the main measure of effect. The study will use existing multinational distributed data sources, such as administrative healthcare data, electronic health records, and potentially disease registries, which will not be collected primarily for this research but do reflect care in usual clinical practice. Exposure in the automated datasets will be based on prescription or dispensing data. As in usual practice, patients may switch between study drugs, and thus the analysis will be episode-of-use level, rather than patient-level. Propensity scores based on relevant baseline demographics, clinical characteristics, and number of prior treatments at the start of each new treatment episode will be used to adjust for potential confounding in comparative analyses.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Bristol-Myers Squibb (BMS)

Optum

Germany

Deutsche Multiple Sklerose Gesellschaft, Germany

Study timelines

Date when funding contract was signed

Planned: 30/06/2020

Actual: 02/09/2021

Study start date

Planned: 30/06/2022

Actual: 30/06/2022

Data analysis start date

Planned: 30/06/2023

Actual: 30/06/2023

Date of interim report, if expected

Planned: 31/12/2024

Date of final study report

Planned: 31/12/2033

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol Myers Squibb

Study protocol

Initial protocol

IM047-009 Protocol_redacted_v3.pdf

Updated protocol

im047009-protamend01_Redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)