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

Novartis

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Drug: Fingolimod

Drug: other disease-modifying therapy

Study type

Observational

Funder types

Industry

Identifiers

NCT01442194

CFTY720D2403

Details and patient eligibility

About

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.

Enrollment

3,076 patients

Sex

All

Volunteers

No Healthy Volunteers

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