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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Burnaby, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fingolimod

Drug

Primary outcomes

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

Time frame: Throughout the entirety of the study up to a maximum of 8 years

Secondary outcomes

Long-term effectiveness data, particularly including clinical disease and patient outcome related parameters such as relapse and disability

Time frame: Throughout the entirety of the study up to a maximum of 8 years

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jan 24, 2011
Registry last updated: Sep 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed