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



Status:Recruiting
Conditions:Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:Any
Updated:2/28/2019
Start Date:August 1, 2011
End Date:December 26, 2022
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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Long-term, Prospective,Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying Therapy

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.


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
We found this trial at
186
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Amherst, New York 14226
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Albany, New York 12208
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1 Health Plaza
Cedarhurst, New York 11516
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Chapel Hill, North Carolina 27599
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