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A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Out Comes, Safety and Tolerability of Fingolimod

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Trial Conditions
  • Relapsing Forms of Multiple Sclerosis
What is the purpose of this trial?

The purpose of this study is to evaluate patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patient with Relapsing Forms of Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of two treatment arms: fingolimod vs. standard of care DMT.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18  - 65 

Gender:
Both

Eligibility

Inclusion Criteria:

- Relapsing Remitting MS

- EDSS 0-5.5

- Treatment with MS DMT for 6 months

- Fingolimod naive

Exclusion Criteria:

- Immune system diseases other than MS

- Macular edema

- History of selected prior infections and criteria for immunizations

- History of selected immune system treatments and/or medications

- Selected cardiovascular, pulmonary, or hepatic conditions

- Selected abnormal laboratory values

- Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply

Gender: Both
Steward Physician(s)
  • Novartis Pharmaceuticals
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Drug
  • Fingolimod
  • Avonex®, Copaxone®, Rebif®, Betaseron® or Extavia®
Physician Researcher

Investigator Name:

  • Novartis Pharmaceuticals

Other Information

Sponsor: Novartis
Phase: Phase 4
Trial ID: NCT01216072
Volunteers:  Not Accepting Healthy Volunteers

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