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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: (T,G)-A-L; Fingolimod Hydrochloride; Glatiramer Acetate; Interferon-beta; Interferons

Criteria

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