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

NCT01216072 | Completed Phase 4 Results

• 1 other identifier: CFTY720DUS01
• Study Type: interventional
• Target: 1,053
• Locations: 3 countries
• Sites: 149

Brief Summary

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.

Conditions

Relapsing Forms of Multiple Sclerosis

Keywords

Relapsing Forms of Multiple Sclerosis; Disease Modifying Therapy; fingolimod; Patient Reported Outcomes

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6

  The TSQM was developed and validated as a general measure for treatment satisfaction. It contains 14 items assessing the following 4 domains: effectiveness (sum of scores for questions 1 - 3), side effects (sum of scores for questions 4 - 8), convenience (sum of scores for questions 9 - 11) and Global Satisfaction (sum of scores for questions 12 - 14). The primary analysis was on Global Satisfaction. Question 12 scored as 1(not at all confident) to 5 (extremely confident); question 13 scored as 1(not at all certain) to 5(extremely certain); and question 14 scored as 1(extremely dissatisfied) to 7(extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.

  Baseline, Month 6

Secondary Outcomes (9)

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

  9 months (6 month core + 3 month Extension)

• Change From Baseline in Patient-reported Activities of Daily Living (ADL) Using the Multiple Sclerosis Activities Scale (PRIMUS-Activities) at Month 6

  Baseline, Month 6

• Change From Baseline in Patient-reported Fatigue Using the Fatigue Severity Scale (FSS)

  Baseline, Month 3, Month 6

• Change From Baseline in the Patient-reported Effectiveness Subscale Using the TSQM v1.4

  Baseline, Month 6

• Change From Baseline in the Patient-reported Side Effects Subscale Using the TSQM v1.4

  Baseline, Month 6

Study Arms (2)

Fingolimod

EXPERIMENTAL

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

Drug: Fingolimod

Multiple Sclerosis Disease Modifying Treatments (MS DMTs)

ACTIVE COMPARATOR

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.

Drug: Standard MS DMTs

Interventions

Fingolimod DRUG

0.5 mg/day oral capsule

Also known as: GILENYA™

Fingolimod

Standard MS DMTs DRUG

Also known as: Avonex®,, Copaxone®,, Rebif®,, Betaseron®,, Extavia®

Multiple Sclerosis Disease Modifying Treatments (MS DMTs)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (149)

Novartis Investigative Site

Birmingham, Alabama, 35209, United States

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Novartis Investigative Site

Cullman, Alabama, 35058, United States

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Phoenix, Arizona, 85004, United States

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Phoenix, Arizona, 85006, United States

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Phoenix, Arizona, 85013, United States

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Phoenix, Arizona, 85032, United States

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Tucson, Arizona, 85741, United States

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Anaheim, California, 92801, United States

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Berkeley, California, 94705, United States

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Fresno, California, 93710, United States

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Fullerton, California, 92835, United States

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La Habra, California, 90631, United States

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Loma Linda, California, 92354, United States

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Newport Beach, California, 92660, United States

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Oceanside, California, 92056, United States

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Sacramento, California, 95817, United States

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Walnut Creek, California, 94598, United States

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Boulder, Colorado, 80304, United States

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Colorado Springs, Colorado, 80920, United States

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Fort Collins, Colorado, 80528, United States

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Fairfield, Connecticut, 06824, United States

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New London, Connecticut, 06320, United States

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Stratford, Connecticut, 06615, United States

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Dover, Delaware, 19901, United States

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Newark, Delaware, 19713, United States

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Atlantis, Florida, 33462-6608, United States

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Bradenton, Florida, 32405, United States

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Doral, Florida, 33166, United States

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Fort Lauderdale, Florida, 33308, United States

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Hollywood, Florida, 33021, United States

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Jacksonville, Florida, 32209, United States

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Jacksonville, Florida, 32216, United States

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Lighthouse PT, Florida, 33064, United States

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Maitland, Florida, 32751, United States

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Miami, Florida, 33015, United States

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Miami, Florida, 33133, United States

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Pompano Beach, Florida, 33060, United States

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Ponte Vedra Beach, Florida, 32082-4627, United States

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Port Orange, Florida, 32127, United States

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Sarasota, Florida, 34243, United States

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St. Petersburg, Florida, 33713, United States

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Sunrise, Florida, 33351, United States

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Tallahassee, Florida, 32308, United States

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Tampa, Florida, 33609, United States

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Tampa, Florida, 33612, United States

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Vero Beach, Florida, 32960, United States

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West Palm Beach, Florida, 33407, United States

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Atlanta, Georgia, 30302, United States

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Atlanta, Georgia, 30309, United States

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Columbus, Georgia, 31901, United States

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Decatur, Georgia, 30083, United States

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Idaho Falls, Idaho, 83402, United States

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Elk Grove Village, Illinois, 60007, United States

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Evanston, Illinois, 60201, United States

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Flossmoor, Illinois, 60422, United States

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Northbrook, Illinois, 60062, United States

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Anderson, Indiana, 46011, United States

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Indianapolis, Indiana, 46202-5111, United States

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Indianapolis, Indiana, 46256, United States

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Merrillville, Indiana, 46410, United States

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Valparaiso, Indiana, 46383, United States

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Des Moines, Iowa, 50314-2611, United States

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Lenexa, Kansas, 66214, United States

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Baton Rouge, Louisiana, 70809, United States

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Destrehan, Louisiana, 70047, United States

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Hammond, Louisiana, 70403, United States

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Metairie, Louisiana, 70001, United States

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Shreveport, Louisiana, 71101, United States

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Shreveport, Louisiana, 71130, United States

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Baltimore, Maryland, 21201, United States

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Bethesda, Maryland, 20814, United States

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Boston, Massachusetts, 02135, United States

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Springfield, Massachusetts, 01104, United States

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Worcester, Massachusetts, 01608, United States

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Worcester, Massachusetts, 01665, United States

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Detroit, Michigan, 48201, United States

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Grand Rapids, Michigan, 49503, United States

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Kalamazoo, Michigan, 49007, United States

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Southfield, Michigan, 48034, United States

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Bolivar, Missouri, 65613, United States

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Kansas City, Missouri, 64111, United States

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Kansas City, Missouri, 64132, United States

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Nixa, Missouri, 65714-7807, United States

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North Kansas City, Missouri, 64116, United States

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St Louis, Missouri, 63104, United States

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Billings, Montana, 59102, United States

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Freehold, New Jersey, 07728, United States

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Somerset, New Jersey, 08873, United States

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Teaneck, New Jersey, 07666, United States

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Toms River, New Jersey, 08755, United States

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Amherst, New York, 14226, United States

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Latham, New York, 12110, United States

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New York, New York, 10023, United States

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Patchogue, New York, 11772, United States

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Plainview, New York, 11803, United States

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Asheville, North Carolina, 28806, United States

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Burlington, North Carolina, 27215, United States

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Charlotte, North Carolina, 28204, United States

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Charlotte, North Carolina, 28207, United States

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Greensboro, North Carolina, 27401, United States

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Greenville, North Carolina, 27834, United States

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Raleigh, North Carolina, 27607, United States

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Salisbury, North Carolina, 28144, United States

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Wilmington, North Carolina, 28401, United States

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Winston-Salem, North Carolina, 27103, United States

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Akron, Ohio, 44320, United States

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Bellevue, Ohio, 44811, United States

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Canton, Ohio, 44718, United States

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Cincinnati, Ohio, 45219, United States

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Columbus, Ohio, 43221, United States

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Uniontown, Ohio, 44685, United States

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Oklahoma City, Oklahoma, 73112, United States

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Corvallis, Oregon, 97330, United States

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Eugene, Oregon, 97401, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97223, United States

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Monroeville, Pennsylvania, 15146, United States

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Rumford, Rhode Island, 02916, United States

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Beufort, South Carolina, 29902, United States

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Columbia, Tennessee, 38401, United States

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Cordova, Tennessee, 38018, United States

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Knoxville, Tennessee, 37934, United States

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Nashville, Tennessee, 37205, United States

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Austin, Texas, 78756, United States

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Colleyville, Texas, 76034, United States

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Dallas, Texas, 75204, United States

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Houston, Texas, 77025, United States

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Lubbock, Texas, 79410, United States

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Plano, Texas, 75075, United States

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Round Rock, Texas, 78681, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78258, United States

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Sherman, Texas, 75092, United States

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Salt Lake City, Utah, 84103, United States

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Newport News, Virginia, 23606, United States

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Richmond, Virginia, 23226, United States

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Roanoke, Virginia, 24014, United States

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Vienna, Virginia, 22182, United States

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Kirkland, Washington, 98034, United States

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Seattle, Washington, 98122, United States

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Seattle, Washington, 98144, United States

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Morgantown, West Virginia, 26506-9260, United States

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Calgary, Alberta, T2N 2T9, Canada

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Nepean, Ontario, K2G 6E2, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Greenfield Park, Quebec, J4V 2J2, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H3A 2B4, Canada

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Novartis Investigative Site

Guaynabo, 00969, Puerto Rico

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Related Publications (4)

• Hughes B, Cascione M, Freedman MS, Agius M, Kantor D, Gudesblatt M, Goldstick LP, Agashivala N, Schofield L, McCague K, Hashmonay R, Barbato L; EPOC study investigators. First-dose effects of fingolimod after switching from injectable therapies in the randomized, open-label, multicenter, Evaluate Patient OutComes (EPOC) study in relapsing multiple sclerosis. Mult Scler Relat Disord. 2014 Sep;3(5):620-8. doi: 10.1016/j.msard.2014.06.006. Epub 2014 Jul 3.

  PMID: 26265274 DERIVED

• Fox E, Edwards K, Burch G, Wynn DR, LaGanke C, Crayton H, Hunter SF, Huffman C, Kim E, Pestreich L, McCague K, Barbato L; EPOC study investigators. Outcomes of switching directly to oral fingolimod from injectable therapies: Results of the randomized, open-label, multicenter, Evaluate Patient OutComes (EPOC) study in relapsing multiple sclerosis. Mult Scler Relat Disord. 2014 Sep;3(5):607-19. doi: 10.1016/j.msard.2014.06.005. Epub 2014 Jul 4.

  PMID: 26265273 DERIVED

• Calkwood J, Cree B, Crayton H, Kantor D, Steingo B, Barbato L, Hashmonay R, Agashivala N, McCague K, Tenenbaum N, Edwards K. Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial. BMC Neurol. 2014 Nov 26;14:220. doi: 10.1186/s12883-014-0220-1.

  PMID: 25424122 DERIVED

• Cascione M, Wynn D, Barbato LM, Pestreich L, Schofield L, McCague K. Randomized, open-label study to evaluate patient-reported outcomes with fingolimod after changing from prior disease-modifying therapy for relapsing multiple sclerosis: EPOC study rationale and design. J Med Econ. 2013 Jul;16(7):859-65. doi: 10.3111/13696998.2013.802239. Epub 2013 May 20.

  PMID: 23647445 DERIVED

Related Links

• Click here for more information about this study:

MeSH Terms

Interventions

Fingolimod Hydrochloride; Interferon beta-1a; Glatiramer Acetate; Interferon beta-1b

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 Pharmaceuticals

trialandresults.registries@novartis.com

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: September 7, 2010
• First Posted: October 7, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 10, 2014
• Results First Posted: December 5, 2013

Record last verified: 2014-01

Locations

US (142); CA (6); PR (1)