Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies

Study Overview
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Brief Summary
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The purpose of this world-wide prospective parallel-cohort study in patients with relapsing forms of MS, either newly treated with fingolimod or receiving another disease-modifying therapy, is to further explore the incidence of selected safety- related outcomes and to further monitor the overall safety profile of fingolimod under conditions of routine medical practice.

Official Title
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Long-term, Prospective,Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying Therapy

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: other disease-modifying therapy
* Drug: Fingolimod


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients that as part of their routine clinical care and according to the locally approved label, are either; Starting fingolimod at time of study entry. Starting another approved DMT or started within maximum 6 months prior to study entry. Patients, or a able legal representative of the patient, who are willing to provide written informed consent. Fingolimod patients will constitute the fingolimod cohort while patients with the other DMT will constitute the parallel cohort Exclusion Criteria: Patients previously or currently treated with a cytotoxic agent (e.g. mitoxantrone, cladribine, alemtuzumab) or natalizumab Patients participating simultaneously in another study with inclusion/exclusion criteria more restrictive than the label or an interventional study unless this is a study on fingolimod lasting 1 month maximum Other protocol-defined inclusion/exclusion criteria may apply
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fingolimod<br>non-interventional | Drug: Fingolimod<br> <br> |
| parallel cohort<br>non-interventional | Drug: other disease-modifying therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For each of the selected safety outcomes, number of patients with a reported event since study start | Incidence of AEs for bradyarrhythmias, liver toxicity, macular edema, infections | Patients will be followed for an expected average of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients SAEs since study start |  | Patients will be followed for an expected average of 5 years | 
| PRIMUS activities, comparison of mean change between the 2 cohorts |  | Patients will be followed for an expected average of 5 years | 
| TSQM-9, comparison between the 2 cohorts |  | Patients will be followed for an expected average of 5 years | 
| WPAI-GH, comparison of mean change between the 2 cohorts |  | Patients will be followed for an expected average of 5 years | 
| MSIS-29, comparison of mean change between the 2 cohorts |  | Patients will be followed for an expected average of 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, fingolimod, observational study