SWITCH - ITA: 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)
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort 1
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Outcome Measures
Primary Outcome Measures
- 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
- 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
Secondary Outcome Measures
- Expanded Disability Status Score (EDSS) [At baseline, week 12, and week 24]
Mean EDSS score in patients enrolled in the study
- MRI [At baseline, week 12, and week 24]
Number of new or enlarging T2 lesions and T1 Gadolinium Enhancing Lesions (GdE) lesions.
- TSQM [At baseline and week 24]
Treatment Satisfaction Questionnaire for Medication
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with RRMS according to 2017 revised McDonald criteria
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Patients who switched a previous first or second line DMT to ozanimod between 4 and 12 weeks before the enrollment
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Patient with a MRI performed within three months before the enrollment
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Patient eligible to ozanimod according to SmPC
Exclusion Criteria:
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Patients with clinical forms of MS other than RRMS
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Patients unable to participate for various reasons
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Patients participating in another clinical study with an investigational product if the study considers the switching behavior as an endpoint or objective
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Contraindications to ozanimod according to SmPC
Other protocol-defined Inclusion/Exclusion Criteria apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
- BMS Clinical Trial Patient Recruiting
Publications
None provided.- IM047-1038