Status:
COMPLETED
Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
Brief Summary
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 furt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 10 2020
Estimated Enrollment :
3076 Patients enrolled
Trial Details
Trial ID
NCT01442194
Start Date
August 1 2011
End Date
July 10 2020
Last Update
January 14 2022
Active Locations (238)
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1
Novartis Investigative Site
Birmingham, Alabama, United States, 35209
2
Novartis Investigative Site
Birmingham, Alabama, United States, 35233-0271
3
Novartis Investigative Site
Birmingham, Alabama, United States, 35235
4
Novartis Investigative Site
Cullman, Alabama, United States, 35058