Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program
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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.
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
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
Resource links provided by the National Library of Medicine
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 Outcome Measures
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 ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with relapsing forms of MS who have participated in previous fingolimod trials and now taking commercially available fingolimod as part of routine medical care
Patients who are prescribed fingolimod as part of their routine medical care
Patients who have participated in a prior fingolimod clinical trials
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