Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)

Novartis

Status and phase: Completed; Phase 4

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: Interferon beta - 1a (IFN); Drug: Glatiramer acetate (GA); Drug: Fingolimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT01534182

CFTY720DRU01

Details and patient eligibility

About

A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy.

Enrollment: 298 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent must be obtained before any assessment is performed.
• Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria (McDonald et al 2001, Polman et al 2005) (Appendix 2).
• Patients who explicitly agree to be assigned to a treatment group that may receive or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
• Male or female patients aged 18-70 years.
• An Expanded Disability Status Scale (EDSS) score of 0-6 inclusive.
• Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.
• Naïve to treatment with fingolimod.

Exclusion criteria

• A manifestation of MS other than those defined in the inclusion criteria.
• A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
• History of malignancy of any organ system.
• Diagnosis of macular edema during Screening Phase.
• Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to have positive HIV antibody test.
• Patients who have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to baseline.
• Patients who have received total lymphoid irradiation or bone marrow transplantation.
• History of selected immune system treatments and/or medications.
• Any medically unstable condition, as assessed by the investigator.
• Selected cardiovascular, or hepatic conditions
• Selected abnormal laboratory values.
• Patients with any other disease or clinical condition (including neurologic or psychiatric disorders) which may affect patient enrollment into the study and study medication use by the Investigators' opinion.
• Participation in any clinical research study evaluating another not approved in Russia investigational drug or therapy within 6 months prior to baseline.
• History of hypersensitivity to the study drug or to drugs of similar chemical classes.
• Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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298 participants in 2 patient groups

Fingolimod

Experimental group

Description:

Participants received 0.5 mg orally once a day.

Treatment:

Drug: Fingolimod

Standard Disease Modifying Therapy (DMT)

Active Comparator group

Description:

Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.

Treatment:

Drug: Glatiramer acetate (GA)

Drug: Interferon beta - 1a (IFN)