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

A Long Term, Multicenter, Non-interventional, Observational Study Monitoring Long-term Safety and Effectiveness of Fingolimod 0.5 mg in Patients With Multiple Sclerosis Who Have Participated in the Fingolimod Clinical Development Program

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01281657

Enrollment

Registered

2011-01-24

Start date

2011-02-28

Completion date

2012-07-31

Last updated

2012-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Fingolimod, FTY720, Relapsing forms of multiple sclerosis, Multiple sclerosis, MS, Safety, Efficacy

Brief summary

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.

Interventions

DRUGfingolimod

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
Long-term safety data in patients with relapsing forms of multiple sclerosis who have participated in clinical trials with fingolimod and who are now taking prescribed fingolimod under the conditions of routine medical practice	Throughout the entirety of the study up to a maximum of 8 years

Secondary

Measure	Time frame
Long-term effectiveness data, particularly including clinical disease and patient outcome related parameters such as relapse and disability	Throughout the entirety of the study up to a maximum of 8 years

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026