A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolera
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)
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
Compared with
- Interferon beta-1a
Interferon alpha/beta receptor agonist
Results by group
Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6
Baseline, Month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod | 22.5 units on a scale | 27.1 (Standard Deviation) | 714 |
| Multiple Sclerosis Disease Modifying Treatments (MS DMTs) | 3.5 units on a scale | 20.57 (Standard Deviation) | 221 |
Fingolimod
Multiple Sclerosis Disease Modifying Treatments (MS DMTs)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Fingolimod | 783 | 31 (4.0%) | |
| Standard MS DMT | 245 | 5 (2.0%) | |
| Fingolimod Extension Phase | 193 | 7 (3.6%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6
Baseline, Month 6
Quality of life (reported by participants)Safety
Other measures (9)
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
9 months (6 month core + 3 month Extension)
SafetyChange From Baseline in Patient-reported Activities of Daily Living (ADL) Using the Multiple Sclerosis Activities Scale (PRIMUS-Activities) at Month 6
Baseline, Month 6
Quality of life (reported by participants)Change From Baseline in Patient-reported Fatigue Using the Fatigue Severity Scale (FSS)
Baseline, Month 3, Month 6
FatigueQuality of life (reported by participants)Change From Baseline in the Patient-reported Effectiveness Subscale Using the TSQM v1.4
Baseline, Month 6
Quality of life (reported by participants)Change From Baseline in the Patient-reported Side Effects Subscale Using the TSQM v1.4
Baseline, Month 6
Quality of life (reported by participants)SafetyChange From Baseline in the Patient-reported Convenience Subscale Using the TSQM v1.4
Baseline, Month 6
Quality of life (reported by participants)Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2)
Baseline, Month 6
PainQuality of life (reported by participants)Change From Baseline in Patient-reported Depression Using the Beck Depression Inventory (BDI-II)
Baseline, Month 3, Month 6
Mood and sleepQuality of life (reported by participants)Physician-reported Clinical Global Impression of Improvement (CGI-I)
Month 3, Month 6
Who could take part
Relapsing MS · 18 to 65 · EDSS 0 to 5.5
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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
Results
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
Results
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
Results
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
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History
Started
Aug 2010
Main results due
Aug 2012
Finished
Aug 2012
Results posted
Dec 2013