Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program

Novartis

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Drug: fingolimod

Study type: Observational

Funder types: Industry

Identifiers

NCT01281657

CFTY720D2399E1

Details and patient eligibility

About

The purpose of this observational study is to collect long-term data on safety and effectiveness of fingolimod, particularly including clinical disease and patient outcome related parameters such as relapse and disability, in patients who have participated in prior trials within the fingolimod clinical development program. Furthermore, this study explores the incidence of selected safety related outcomes of fingolimod treatment during follow-up visits within the context of routine medical practice.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are prescribed fingolimod as part of their routine medical care
• Patients who have participated in a prior fingolimod clinical trials

Exclusion criteria

• Restrictions regarding the use of fingolimod while pregnant or nursing in accordance with the local prescribing label
• Any patient who has prematurely discontinued from the previous fingolimod trial

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

64 participants in 1 patient group

Prescribed fingolimod 0.5 mg/day

Treatment:

Drug: fingolimod