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

NCT ID: NCT01534182

Last Updated: 2014-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-06-30

Brief 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.

Conditions

Relapsing Remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fingolimod

Participants received 0.5 mg orally once a day.

Group Type: EXPERIMENTAL

Fingolimod

Intervention Type: DRUG

0.5 mg orally once a day

Standard Disease Modifying Therapy (DMT)

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

Group Type: ACTIVE_COMPARATOR

Interferon beta - 1a (IFN)

Intervention Type: DRUG

44 mcg subcutaneously three times a week

Glatiramer acetate (GA)

Intervention Type: DRUG

20 mg subcutaneously once a day

Interventions

Fingolimod

0.5 mg orally once a day

Intervention Type: DRUG

Interferon beta - 1a (IFN)

44 mcg subcutaneously three times a week

Intervention Type: DRUG

Glatiramer acetate (GA)

20 mg subcutaneously once a day

Intervention Type: DRUG

Other Intervention Names

Gilenya; Rebif; Copaxone

Eligibility 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Arkhangelsk, Russia, Russia

Novartis Investigative Site

Barnaul, , Russia

Novartis Investigative Site

Belgorod, , Russia

Novartis Investigative Site

Kazan', , Russia

Novartis Investigative Site

Kemerovo, , Russia

Novartis Investigative Site

Khanty-Mansiysk, , Russia

Novartis Investigative Site

Kirov, , Russia

Novartis Investigative Site

Krasnodar, , Russia

Novartis Investigative Site

Kursk, , Russia

Novartis Investigative Site

Moscow, , Russia

Novartis Investigative Site

Moscow, , Russia

Novartis Investigative Site

N.Novgorod, , Russia

Novartis Investigative Site

Nizhny Novgorod, , Russia

Novartis Investigative Site

Nizhny Novgorod, , Russia

Novartis Investigative Site

Novosibirsk, , Russia

Novartis Investigative Site

Perm, , Russia

Novartis Investigative Site

Saint Petersburg, , Russia

Novartis Investigative Site

Saransk, , Russia

Novartis Investigative Site

Saratov, , Russia

Novartis Investigative Site

Smolensk, , Russia

Novartis Investigative Site

Tomsk, , Russia

Novartis Investigative Site

Tver', , Russia

Novartis Investigative Site

Tyumen, , Russia

Novartis Investigative Site

Ufa, , Russia

Novartis Investigative Site

Ulyanovsk, , Russia

Novartis Investigative Site

Yaroslavl, , Russia

Countries

Russia

Other Identifiers

CFTY720DRU01

Identifier Type: -

Identifier Source: org_study_id