A Study to Describe the Switching From a First- or Second-line Disease Modifying Therapy (DMT) to Ozanimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)

NCT05658601 | Completed

• 1 other identifier: IM047-1038
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to describe the reasons, therapy, and/or disease for changing first or second line Disease Modifying Therapy (DMT) to ozanimod in participants with Relapsing Remitting Multiple Sclerosis (RRMS).

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis; Ozanimod

Outcome Measures

Primary Outcomes (2)

• Reason for switching treatment

  Reason for switching the previous treatment: Lack of efficacy, Poor safety/tolerability, Difficulty in administration, Poor compliance, Patient's request, or other reasons

  At baseline

• Mode of switching treatment

  Wash-out from previous treatment (first/second line DMT) (days), overlapping (days), dosage (first/second line DMT and ozanimod), concomitant treatments

  At baseline

Secondary Outcomes (6)

• Expanded Disability Status Score (EDSS)

  At baseline, week 12, and week 24

• MRI

  At baseline, week 12, and week 24

• TSQM

  At baseline and week 24

• Lymphocyte sub populations

  At baseline, week 12, and week 24

• Incidence of Adverse Events (AEs)

  Continuous (Up to 42 months)

Study Arms (1)

Cohort 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population is composed of 180 participants 18-55 years with Relapsing Remitting Multiple Sclerosis (RRMS) diagnosed according to 2017 revised McDonald criteria, switching from a first or second line Disease Modifying Therapy (DMT) to ozanimod, and in treatment with ozanimod between 4 and 12 weeks before the enrollment.

You may qualify if:

• Patients with RRMS according to 2017 revised McDonald criteria
• Patients who switched a previous first or second line DMT to ozanimod between 4 and 12 weeks before the enrollment
• Patient with a MRI performed within three months before the enrollment
• Patient eligible to ozanimod according to SmPC

You may not qualify if:

• Patients with clinical forms of MS other than RRMS
• Patients unable to participate for various reasons
• Patients participating in another clinical study with an investigational product if the study considers the switching behavior as an endpoint or objective
• Contraindications to ozanimod according to SmPC

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Isernia, 86077, Italy

Location

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 21, 2022
• Study Start: July 14, 2023
• Primary Completion: July 3, 2025
• Study Completion: July 3, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

IT (1)