Switching to Ozanimod for Relapsing Remitting Multiple Sclerosis
SWITCH - ITA A Multicentre, Single Country, Prospective Non Interventional Observational Study to Describe the Switching From a First- or Second-line Disease Modifying Therapy (DMT) to Ozanimod, in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated According to Clinical Practice.
Bristol-Myers Squibb · NCT05658601
This study looks at why people with relapsing remitting multiple sclerosis switch to a new medication called ozanimod and how it affects their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Bristol-Myers Squibb (industry) |
| Locations | 1 site (Isernia) |
| Trial ID | NCT05658601 on ClinicalTrials.gov |
What this trial studies
This study aims to describe the reasons and circumstances under which patients with Relapsing Remitting Multiple Sclerosis (RRMS) switch from their current first or second-line Disease Modifying Therapy (DMT) to ozanimod. Participants must have made this switch between 4 and 12 weeks prior to enrollment and have undergone an MRI within the last three months. The study will collect data on therapy changes and disease progression to better understand the impact of ozanimod in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with RRMS who have recently switched to ozanimod from another DMT.
Not a fit: Patients with clinical forms of MS other than RRMS or those who have contraindications to ozanimod will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness and reasons for switching to ozanimod, potentially improving treatment strategies for RRMS patients.
How similar studies have performed: While there may be studies on DMT switching, this specific observational approach focusing on ozanimod is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Isernia
- Neuromed Istituto Neurologico Mediterraneo — Isernia, Italy (RECRUITING)
Study contacts
- Study coordinator: BMS Study Connect Contact Center http://www.bmsstudyconnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Ozanimod