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

NCT01534182 | Completed Phase 4 Results

• 1 other identifier: CFTY720DRU01
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 26

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

Keywords

Relapsing Remitting Multiple Sclerosis (RRMS); Fingolimod; Disease Modifying Therapy (DMT); TSQM-9

Outcome Measures

Primary Outcomes (1)

• Change in Patient-reported Treatment Satisfaction

  The Treatment Satisfaction Questionnaire for Medication (TSQM) contains 14 items assessing the following 4 domains: effectiveness (items 1 - 3), side effects (items 4 - 8), convenience (items 9 - 11) and global satisfaction (items 12 - 14). The primary outcome was measured on the global satisfaction domain. Item 12 scored as 1 (not at all confident) to 5 (extremely confident); item 13 scored as 1 (not at all certain) to 5 (extremely certain); and item 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). Responses to items were summed and transformed: specifically, TSQM v 1.4 domain scale scores were computed by adding the items loading on each domain. The lowest possible score was subtracted from the composite score and divided by the greatest possible score range. This provided a transformed score between 0 and 1 that was then multiplied by 100. The final transformed score ranges from 0 to 100, with higher scores indicating better treatment satisfaction.

  Baseline, 6 months

Secondary Outcomes (4)

• Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death

  6 months

• Changes in Patient-reported Effectiveness, Side Effects and Convenience

  Baseline, 6 months

• Change in Patient-reported Depression

  Baseline, 6 months

• Change in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Acute (SF-36 v2 Acute)

  Baseline, 6 months

Study Arms (2)

Fingolimod

EXPERIMENTAL

Participants received 0.5 mg orally once a day.

Drug: Fingolimod

Standard Disease Modifying Therapy (DMT)

ACTIVE COMPARATOR

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

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

Interventions

Fingolimod DRUG

0.5 mg orally once a day

Also known as: Gilenya

Fingolimod

Interferon beta - 1a (IFN) DRUG

44 mcg subcutaneously three times a week

Also known as: Rebif

Standard Disease Modifying Therapy (DMT)

Glatiramer acetate (GA) DRUG

20 mg subcutaneously once a day

Also known as: Copaxone

Standard Disease Modifying Therapy (DMT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (26)

Novartis Investigative Site

Arkhangelsk, Russia, 163045, Russia

Location

Novartis Investigative Site

Barnaul, 656024, Russia

Location

Novartis Investigative Site

Belgorod, 308007, Russia

Location

Novartis Investigative Site

Kazan', 420021, Russia

Location

Novartis Investigative Site

Kemerovo, 650066, Russia

Location

Novartis Investigative Site

Khanty-Mansiysk, 628012, Russia

Location

Novartis Investigative Site

Kirov, 610014, Russia

Location

Novartis Investigative Site

Krasnodar, 350086, Russia

Location

Novartis Investigative Site

Kursk, 305007, Russia

Location

Novartis Investigative Site

Moscow, 119992, Russia

Location

Novartis Investigative Site

Moscow, 127018, Russia

Location

Novartis Investigative Site

N.Novgorod, 603126, Russia

Location

Novartis Investigative Site

Nizhny Novgorod, 603076, Russia

Location

Novartis Investigative Site

Nizhny Novgorod, 603155, Russia

Location

Novartis Investigative Site

Novosibirsk, 630087, Russia

Location

Novartis Investigative Site

Perm, 614990, Russia

Location

Novartis Investigative Site

Saint Petersburg, 197376, Russia

Location

Novartis Investigative Site

Saransk, 430032, Russia

Location

Novartis Investigative Site

Saratov, 410030, Russia

Location

Novartis Investigative Site

Smolensk, 214019, Russia

Location

Novartis Investigative Site

Tomsk, 634050, Russia

Location

Novartis Investigative Site

Tver', 170036, Russia

Location

Novartis Investigative Site

Tyumen, 625048, Russia

Location

Novartis Investigative Site

Ufa, 450000, Russia

Location

Novartis Investigative Site

Ulyanovsk, 432063, Russia

Location

Novartis Investigative Site

Yaroslavl, 150030, Russia

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Fingolimod Hydrochloride; Interferon beta-1a; Glatiramer Acetate

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines; Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Study Director
• Organization: Novartis

+1 (862) 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 16, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 8, 2014
• Results First Posted: August 8, 2014

Record last verified: 2014-08

Locations

RU (26)