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OpenTrials
Active, Not Recruiting

NCT Number: NCT05811416

A Study to Describe the Persistence With Ozanimod Treatment in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants

The purpose of the study is to collect clinical data on the persistence with ozanimod treatment, as well as to describe its effects on participant-relevant outcome parameters in treatment-naïve participants with RRMS.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Relapsing-remitting Multiple Sclerosis (rrMS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Barcelona, 08008, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Relapsing-remitting multiple sclerosis (RRMS) diagnosis by 2017 revised McDonald criteria at the treatment start
  • Participant who started treatment with ozanimod for the first time 3 months (+/- 2 weeks) before inclusion, according to European Union (EU) Summary of Product Characteristics (SmPC) and/or Spanish therapeutic positioning report (TPR) recommendation and following routine clinical practice of the participating hospital
  • Low-to-moderate activity, defined as less than 2 relapses in the previous year before starting the treatment with ozanimod

Exclusion criteria

  • Prior exposure to ozanimod or any other disease modifier treatment (DMT) for RRMS before starting treatment with ozanimod subject of this study
  • Participant who has started ozanimod within a clinical trial

Note: Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

Primary outcomes

  1. Time from ozanimod treatment initiation to ozanimod treatment permanent discontinuation

    Time frame: Up to 24 months

  2. Percentage of participants on treatment with ozanimod at 24 months

    Time frame: At month 24

Secondary outcomes

  1. Percentage of participants with ozanimod treatment at 3 and 12 months

    Time frame: At month 3 and month 12

  2. Percentage of participants with ozanimod treatment discontinuation

    Time frame: Up to 24 months

  3. Percentage of participants switching to treatment alternative

    Time frame: Up to 24 months

  4. Annualized relapse rate at month 12 month and month 24

    Time frame: At month 12 and month 24

  5. Proportion of participants with an increase in Symbol Digit Modalities Test (SDMT) score of ≥4 points

    Time frame: At month 3, 12 and 24

  6. Proportion of participants with a decrease SDMT score of ≥4 points

    Time frame: At month 3, 12 and 24

  7. Proportion of participants with a stable SDMT score

    Time frame: At month 3, 12 and 24

  8. Change from baseline in SDMT score at month 3, 12 and 24

    Time frame: Baseline, Month 3, 12 and 24

  9. Change from baseline in Neurofilament light (NfL) levels at month 6, 12 and 24

    Time frame: Baseline, Month 6, 12 and 24

  10. Proportion of participants with change of ≥1.0 point from baseline in expanded disability status scale (EDSS) score at Month 3, 12 and 24

    Time frame: Baseline, Month 3, 12 and 24

  11. Change from baseline in EDSS score at Month 3, 12 and 24

    Time frame: Baseline, Month 3, 12 and 24

  12. Change from baseline in number of new or enlarging hypointense T1 lesions at month 12 and 24

    Time frame: Baseline, Month 12 and 24

  13. Change from baseline in number of new or enlarging hypointense T2 lesions at month 12 and 24

    Time frame: Baseline, Month 12 and 24

  14. Change from baseline in number of new or enlarging gadolinium enhancing brain lesions at month 12 and 24

    Time frame: Baseline, Month 12 and 24

  15. Number of Participants with at least one Adverse Event (AE)

    Time frame: Up to 24 months

  16. Number of Participants with AE that imply discontinuation of ozanimod

    Time frame: Up to 24 months

  17. Description of sociodemographic characteristics of participants

    Time frame: Baseline, up to 24 months

  18. Description of clinical characteristics of participants

    Time frame: Baseline, up to 24 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Observational, Multicenter Study to Describe the Persistence in Relapsing Remitting Multiple Sclerosis Naive Patients With Low-moderate Activity Treated With Ozanimod (Zeposia®) in Clinical Practice in Spain

Acronym: AppreZiate

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2023
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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