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)

Recruiting

• Conditions: Multiple Sclerosis, Relapsing-Remitting

• Registration Number: NCT05658601
• Lead Sponsor: Bristol-Myers Squibb

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-21
• Study Start: 2023-07-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-11
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Other protocol-defined Inclusion/Exclusion Criteria apply.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mode of switching treatment	At baseline	Wash-out from previous treatment (first/second line DMT) (days), overlapping (days), dosage (first/second line DMT and ozanimod), concomitant treatments
Reason for switching treatment	At baseline	Reason for switching the previous treatment: Lack of efficacy, Poor safety/tolerability, Difficulty in administration, Poor compliance, Patient's request, or other reasons

Secondary Outcome Measures

Name	Time	Method
MRI	At baseline, week 12, and week 24	Number of new or enlarging T2 lesions and T1 Gadolinium Enhancing Lesions (GdE) lesions.
Lymphocyte sub populations	At baseline, week 12, and week 24	The pattern of the sub populations of lymphocytes: CD3, CD4, CD8, CD19, CD56.
Incidence of Adverse Events (AEs)	Continuous (Up to 42 months)	Number of AEs in the study population during the study; AEs will be coded according to MEdDRA.
Incidence of Serious Adverse Events (SAEs)	Continuous (Up to 42 months)	Number of SAEs in the study population during the study; SAEs will be coded according to MEdDRA.
Expanded Disability Status Score (EDSS)	At baseline, week 12, and week 24	Mean EDSS score in patients enrolled in the study
TSQM	At baseline and week 24	Treatment Satisfaction Questionnaire for Medication

Trial Locations

Locations (1)

Neuromed Istituto Neurologico Mediterraneo; 🇮🇹 Isernia, Italy