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

Sponsor:

Brief Summary:

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.

Criteria

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

Novartis Investigative Site, Bakersfield, California, United States, 93311
Novartis Investigative Site, Banning, California, United States, 92220
Novartis Investigative Site, Burbank, California, United States, 91505
Novartis Investigative Site, Fresno, California, United States, 93710
Novartis Investigative Site, Fullerton, California, United States, 92835
Novartis Investigative Site, Fullerton, California, United States, 92835
Novartis Investigative Site, Huntington Beach, California, United States, 92649
Novartis Investigative Site, Irvine, California, United States, 92618
Novartis Investigative Site, Loma Linda, California, United States, 92354
Novartis Investigative Site, Los Angeles, California, United States, 90073
Novartis Investigative Site, Newport Beach, California, United States, 92660
Novartis Investigative Site, Oceanside, California, United States, 92056
Novartis Investigative Site, Placentia, California, United States, 92870
Novartis Investigative Site, Pomona, California, United States, 91767
Novartis Investigative Site, Redding, California, United States, 96001
Novartis Investigative Site, Santa Monica, California, United States, 90404
Novartis Investigative Site, Temecula, California, United States, 92591