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

Novartis Pharmaceuticals3,076 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,076

Conditions

Multiple Sclerosis

Interventions

other disease-modifying therapyDRUG

FingolimodDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (238)

Outcomes

Primary Outcomes

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