Clinical trial NCT01216072: 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
Official title: A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Forms of Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing Forms of Multiple Sclerosis
Keywords: Relapsing Forms of Multiple Sclerosis
Disease Modifying Therapy
fingolimod
Patient Reported Outcomes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-10-07
Enrollment: 1053
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Other protocol-defined inclusion/exclusion criteria applied

Primary outcomes:
measure: Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
timeFrame: 9 months (6 month core + 3 month Extension)
measure: Change From Baseline in Patient-reported Activities of Daily Living (ADL) Using the Multiple Sclerosis Activities Scale (PRIMUS-Activities) at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Patient-reported Fatigue Using the Fatigue Severity Scale (FSS)
timeFrame: Baseline, Month 3, Month 6
measure: Change From Baseline in the Patient-reported Effectiveness Subscale Using the TSQM v1.4
timeFrame: Baseline, Month 6
measure: Change From Baseline in the Patient-reported Side Effects Subscale Using the TSQM v1.4
timeFrame: Baseline, Month 6
measure: Change From Baseline in the Patient-reported Convenience Subscale Using the TSQM v1.4
timeFrame: Baseline, Month 6
measure: Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2)
timeFrame: Baseline, Month 6
measure: Change From Baseline in Patient-reported Depression Using the Beck Depression Inventory (BDI-II)
timeFrame: Baseline, Month 3, Month 6
measure: Physician-reported Clinical Global Impression of Improvement (CGI-I)
timeFrame: Month 3, Month 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Cullman
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Anaheim
country: United States
facility: Novartis Investigative Site
state: California
city: Berkeley
country: United States
facility: Novartis Investigative Site
state: California
city: Fresno
country: United States
facility: Novartis Investigative Site
state: California
city: Fullerton
country: United States
facility: Novartis Investigative Site
state: California
city: La Habra
country: United States
facility: Novartis Investigative Site
state: California
city: Loma Linda
country: United States
facility: Novartis Investigative Site
state: California
city: Newport Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Oceanside
country: United States
facility: Novartis Investigative Site
state: California
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: Walnut Creek
country: United States
facility: Novartis Investigative Site
state: California
city: Boulder
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Colorado Springs
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Fort Collins
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Fairfield
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: New London
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Stratford
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Dover
country: United States
facility: Novartis Investigative Site
state: Delaware
city: Newark
country: United States
facility: Novartis Investigative Site
state: Delaware
city: Atlantis
country: United States
facility: Novartis Investigative Site
state: Florida
city: Bradenton
country: United States
facility: Novartis Investigative Site
state: Florida
city: Doral
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state: Florida
city: Fort Lauderdale
country: United States
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state: Florida
city: Hollywood
country: United States
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state: Florida
city: Jacksonville
country: United States
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city: Jacksonville
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state: Florida
city: Lighthouse Point
country: United States
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city: Maitland
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Pompano Beach
country: United States
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city: Ponte Vedra Beach
country: United States
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state: Florida
city: Port Orange
country: United States
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state: Florida
city: Sarasota
country: United States
facility: Novartis Investigative Site
state: Florida
city: St. Petersburg
country: United States
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state: Florida
city: Sunrise
country: United States
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state: Florida
city: Tallahassee
country: United States
facility: Novartis Investigative Site
state: Florida
city: Tampa
country: United States
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city: Tampa
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state: Florida
city: Vero Beach
country: United States
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state: Florida
city: West Palm Beach
country: United States
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city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Decatur
country: United States
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state: Georgia
city: Idaho Falls
country: United States
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state: Idaho
city: Elk Grove Village
country: United States
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state: Illinois
city: Evanston
country: United States
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city: Flossmoor
country: United States
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city: Northbrook
country: United States
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city: Anderson
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state: Indiana
city: Indianapolis
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city: Indianapolis
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city: Merrillville
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city: Valparaiso
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city: Des Moines
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city: Lenexa
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state: Kansas
city: Baton Rouge
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state: Louisiana
city: Destrehan
country: United States
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city: Hammond
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city: Metairie
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city: Shreveport
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city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Bethesda
country: United States
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city: Boston
country: United States
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state: Massachusetts
city: Springfield
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state: Massachusetts
city: Worcester
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city: Worcester
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city: Detroit
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state: Michigan
city: Grand Rapids
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city: Southfield
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state: Missouri
city: Kansas City
country: United States
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state: Missouri
city: Nixa
country: United States
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city: St. Louis
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city: Freehold
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city: Somerset
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city: Teaneck
country: United States
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city: Toms River
country: United States
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city: Amherst
country: United States
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city: Latham
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city: Patchogue
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city: Plainview
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state: North Carolina
city: Burlington
country: United States
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state: North Carolina
city: Charlotte
country: United States
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state: North Carolina
city: Charlotte
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state: North Carolina
city: Greensboro
country: United States
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state: North Carolina
city: Greenville
country: United States
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state: North Carolina
city: Raleigh
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state: North Carolina
city: Salisbury
country: United States
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state: North Carolina
city: Wilmington
country: United States
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state: North Carolina
city: Winston-Salem
country: United States
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state: North Carolina
city: Akron
country: United States
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state: Ohio
city: Bellevue
country: United States
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state: Ohio
city: Canton
country: United States
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state: Ohio
city: Cincinnati
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state: Ohio
city: Columbus
country: United States
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state: Ohio
city: Uniontown
country: United States
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state: Ohio
city: Oklahoma City
country: United States
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state: Oklahoma
city: Corvallis
country: United States
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state: Oregon
city: Eugene
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state: Oregon
city: Medford
country: United States
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state: Oregon
city: Portland
country: United States
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state: Oregon
city: Monroeville
country: United States
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state: Pennsylvania
city: Rumford
country: United States
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state: Rhode Island
city: Beufort
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Columbia
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Cordova
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Knoxville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Nashville
country: United States
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state: Tennessee
city: Austin
country: United States
facility: Novartis Investigative Site
state: Texas
city: Colleyville
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Lubbock
country: United States
facility: Novartis Investigative Site
state: Texas
city: Plano
country: United States
facility: Novartis Investigative Site
state: Texas
city: Round Rock
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Sherman
country: United States
facility: Novartis Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Novartis Investigative Site
state: Utah
city: Newport News
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Roanoke
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Vienna
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Kirkland
country: United States
facility: Novartis Investigative Site
state: Washington
city: Seattle
country: United States
facility: Novartis Investigative Site
state: Washington
city: Seattle
country: United States
facility: Novartis Investigative Site
state: Washington
city: Morgantown
country: United States
facility: Novartis Investigative Site
state: West Virginia
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Nepean
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Guaynabo
country: Puerto Rico
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.