A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis (EPOC)

Novartis

Status and phase: Completed; Phase 4

Conditions: Relapsing Forms of Multiple Sclerosis

Treatments: Drug: Standard MS DMTs; Drug: Fingolimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT01216072

CFTY720DUS01

Details and patient eligibility

About

The purpose of this study is to evaluate the change in patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patients 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.

Enrollment: 1,053 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Relapsing forms of MS
• Expanded Disability Status Scale (EDSS) 0-5.5
• Continuous treatment with MS DMT for a minimum of 6 months
• Fingolimod naive

Exclusion criteria

• Immune system diseases other than MS
• Active 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 applied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,053 participants in 2 patient groups

Fingolimod

Experimental group

Description:

Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period .

Treatment:

Drug: Fingolimod

Multiple Sclerosis Disease Modifying Treatments (MS DMTs)

Active Comparator group

Description:

Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.

Treatment:

Drug: Standard MS DMTs