SHS_543073 BOWJ CNOV 15011
Long-term, prospective, multinational, parallel-cohort study monitoring safety in patients with MS newly started on fingolimod once daily or treated with another approved disease-modifying therapy
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.
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
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
James Bowen, M.D.