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 |
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.
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
sites
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