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

Relapsing Forms of Multiple Sclerosis Clinical Trial

— EPOC  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216072
• Other study ID #: CFTY720DUS01
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2010
• Last updated: January 14, 2014
• Start date: August 2010
• Est. completion date: August 2012

Study information

• Verified date: January 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1053
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Forms of Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Fingolimod
0.5 mg/day oral capsule
• Standard MS DMTs

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Greenfield Park	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Nepean	Ontario
Canada	Novartis Investigative Site	Ottawa	Ontario
Puerto Rico	Novartis Investigative Site	Guaynabo
United States	Novartis Investigative Site	Akron	Ohio
United States	Novartis Investigative Site	Amherst	New York
United States	Novartis Investigative Site	Anaheim	California
United States	Novartis Investigative Site	Anderson	Indiana
United States	Novartis Investigative Site	Asheville	North Carolina
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Atlantis	Florida
United States	Novartis Investigative Site	Austin	Texas
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Baton Rouge	Louisiana
United States	Novartis Investigative Site	Bellevue	Ohio
United States	Novartis Investigative Site	Berkeley	California
United States	Novartis Investigative Site	Bethesda	Maryland
United States	Novartis Investigative Site	Beufort	South Carolina
United States	Novartis Investigative Site	Billings	Montana
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Bolivar	Missouri
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Boulder	Colorado
United States	Novartis Investigative Site	Bradenton	Florida
United States	Novartis Investigative Site	Burlington	North Carolina
United States	Novartis Investigative Site	Canton	Ohio
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Colleyville	Texas
United States	Novartis Investigative Site	Colorado Springs	Colorado
United States	Novartis Investigative Site	Columbia	Tennessee
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Columbus	Georgia
United States	Novartis Investigative Site	Cordova	Tennessee
United States	Novartis Investigative Site	Corvallis	Oregon
United States	Novartis Investigative Site	Cullman	Alabama
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Decatur	Georgia
United States	Novartis Investigative Site	Des Moines	Iowa
United States	Novartis Investigative Site	Destrehan	Louisiana
United States	Novartis Investigative Site	Detroit	Michigan
United States	Novartis Investigative Site	Doral	Florida
United States	Novartis Investigative Site	Dover	Delaware
United States	Novartis Investigative Site	Elk Grove Village	Illinois
United States	Novartis Investigative Site	Eugene	Oregon
United States	Novartis Investigative Site	Evanston	Illinois
United States	Novartis Investigative Site	Fairfield	Connecticut
United States	Novartis Investigative Site	Flossmoor	Illinois
United States	Novartis Investigative Site	Fort Collins	Colorado
United States	Novartis Investigative Site	Fort Lauderdale	Florida
United States	Novartis Investigative Site	Freehold	New Jersey
United States	Novartis Investigative Site	Fresno	California
United States	Novartis Investigative Site	Fullerton	California
United States	Novartis Investigative Site	Grand Rapids	Michigan
United States	Novartis Investigative Site	Greensboro	North Carolina
United States	Novartis Investigative Site	Greenville	North Carolina
United States	Novartis Investigative Site	Hammond	Louisiana
United States	Novartis Investigative Site	Hollywood	Florida
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Idaho Falls	Idaho
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Kalamazoo	Michigan
United States	Novartis Investigative Site	Kansas City	Missouri
United States	Novartis Investigative Site	Kansas City	Missouri
United States	Novartis Investigative Site	Kirkland	Washington
United States	Novartis Investigative Site	Knoxville	Tennessee
United States	Novartis Investigative Site	La Habra	California
United States	Novartis Investigative Site	Latham	New York
United States	Novartis Investigative Site	Lenexa	Kansas
United States	Novartis Investigative Site	Lighthouse Point	Florida
United States	Novartis Investigative Site	Loma Linda	California
United States	Novartis Investigative Site	Lubbock	Texas
United States	Novartis Investigative Site	Maitland	Florida
United States	Novartis Investigative Site	Medford	Oregon
United States	Novartis Investigative Site	Merrillville	Indiana
United States	Novartis Investigative Site	Metairie	Louisiana
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Monroeville	Pennsylvania
United States	Novartis Investigative Site	Morgantown	West Virginia
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	New London	Connecticut
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Newark	Delaware
United States	Novartis Investigative Site	Newport Beach	California
United States	Novartis Investigative Site	Newport News	Virginia
United States	Novartis Investigative Site	Nixa	Missouri
United States	Novartis Investigative Site	North Kansas City	Missouri
United States	Novartis Investigative Site	Northbrook	Illinois
United States	Novartis Investigative Site	Oceanside	California
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Patchogue	New York
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Plainview	New York
United States	Novartis Investigative Site	Plano	Texas
United States	Novartis Investigative Site	Pompano Beach	Florida
United States	Novartis Investigative Site	Ponte Vedra Beach	Florida
United States	Novartis Investigative Site	Port Orange	Florida
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Raleigh	North Carolina
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	Roanoke	Virginia
United States	Novartis Investigative Site	Round Rock	Texas
United States	Novartis Investigative Site	Rumford	Rhode Island
United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	Salisbury	North Carolina
United States	Novartis Investigative Site	Salt Lake City	Utah
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	Sarasota	Florida
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Sherman	Texas
United States	Novartis Investigative Site	Shreveport	Louisiana
United States	Novartis Investigative Site	Shreveport	Louisiana
United States	Novartis Investigative Site	Somerset	New Jersey
United States	Novartis Investigative Site	Southfield	Michigan
United States	Novartis Investigative Site	Springfield	Massachusetts
United States	Novartis Investigative Site	St. Louis	Missouri
United States	Novartis Investigative Site	St. Petersburg	Florida
United States	Novartis Investigative Site	Stratford	Connecticut
United States	Novartis Investigative Site	Sunrise	Florida
United States	Novartis Investigative Site	Tallahassee	Florida
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Teaneck	New Jersey
United States	Novartis Investigative Site	Toms River	New Jersey
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	Uniontown	Ohio
United States	Novartis Investigative Site	Valparaiso	Indiana
United States	Novartis Investigative Site	Vero Beach	Florida
United States	Novartis Investigative Site	Vienna	Virginia
United States	Novartis Investigative Site	Walnut Creek	California
United States	Novartis Investigative Site	West Palm Beach	Florida
United States	Novartis Investigative Site	Wilmington	North Carolina
United States	Novartis Investigative Site	Winston-Salem	North Carolina
United States	Novartis Investigative Site	Worcester	Massachusetts
United States	Novartis Investigative Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death	In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.	9 months (6 month core + 3 month Extension)	Yes
Secondary	Change From Baseline in Patient-reported Activities of Daily Living (ADL) Using the Multiple Sclerosis Activities Scale (PRIMUS-Activities) at Month 6	The PRIMUS activity measure is a 15-item assessment of patient-reported ADL. The PRIMUS-Activities total score was calculated by summing the 15 item scores after recoding the responses from 1 - 3 to 0 - 2. Totals scores range from 0 to 30 with higher scores indicating greater activity limitation. If no more than 20% of the items were missing, the total score was the product of the mean response of the non-missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change from baseline indicates improvement.	Baseline, Month 6	No
Secondary	Change From Baseline in Patient-reported Fatigue Using the Fatigue Severity Scale (FSS)	The Fatigue Severity Scale (FSS) is a 9-item assessment scale measuring fatigue and its effects, using a scale from 1 to 7, with higher scores indicating greater fatigue, or greater negative effects of fatigue on daily living. The FSS 9 item total score was calculated by summing the first 9 item scores and dividing by the number of non-missing items. If no more than 20% of the items were missing, the total score was the product of the mean response of the non missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change from baseline indicates improvement.	Baseline, Month 3, Month 6	No
Secondary	Change From Baseline in the Patient-reported Effectiveness Subscale Using the TSQM v1.4	The effectiveness scale was scored as follows: 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	No
Secondary	Change From Baseline in the Patient-reported Side Effects Subscale Using the TSQM v1.4	The Side Effects subscale was scored as follows: question 4 scored as 0(no) or 1(yes); question 5 scored as 1(extremely bothersome) to 5(not at all bothersome); and questions 6 - 8 scored as 1(a great deal) to 5(not at all). 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	No
Secondary	Change From Baseline in the Patient-reported Convenience Subscale Using the TSQM v1.4	The convenience subscale was scored as follows: questions 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy), and question 11 scored as 1(extremely inconvenient) to 7 (extremely convenient). 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	No
Secondary	Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2)	The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.	Baseline, Month 6	No
Secondary	Change From Baseline in Patient-reported Depression Using the Beck Depression Inventory (BDI-II)	The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory. Each item is scored from 0 to 3. The questions in the BDI-II refer to how the patient has been feeling over the past two weeks specifically. The BDI-II total score was calculated by summing the 21 item scores. Final scores ranged from 0 to 63 where higher scores indicated more severe depression. If no more than 20% of the items were missing, the total score was the product of the mean response of the non-missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change indicates improvement.	Baseline, Month 3, Month 6	No
Secondary	Physician-reported Clinical Global Impression of Improvement (CGI-I)	The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time. The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. The assessments were completed at Month 3 and Month 6. A lower score indicates improvement.	Month 3, Month 6	No

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