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

Completed

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT01442194

Run by

Novartis Pharmaceuticals

People needed

3076

Starts

2011-08-01

Expected to finish

2020-07-10

Last updated by the study team

2022-01-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Birmingham, Alabama, United States
• Novartis Investigative Site — Birmingham, Alabama, United States
• Novartis Investigative Site — Cullman, Alabama, United States
• Novartis Investigative Site — Mobile, Alabama, United States
• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Sottsdale, Arizona, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Bakersfield, California, United States
• Novartis Investigative Site — Banning, California, United States
• Novartis Investigative Site — Burbank, California, United States
• Novartis Investigative Site — Fresno, California, United States
• Novartis Investigative Site — Fullerton, California, United States
• Novartis Investigative Site — Huntington Beach, California, United States
• Novartis Investigative Site — Irvine, California, United States
• Novartis Investigative Site — Loma Linda, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Newport Beach, California, United States
• Novartis Investigative Site — Oceanside, California, United States
• Novartis Investigative Site — Placentia, California, United States
• Novartis Investigative Site — Pomona, California, United States
• Novartis Investigative Site — Redding, California, United States
• Novartis Investigative Site — Santa Monica, California, United States
• Novartis Investigative Site — Temecula, California, United States
• Novartis Investigative Site — Aurora, Colorado, United States
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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