Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates
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 Remitting 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
- Interferon beta-1b
Interferon alpha/beta receptor agonist
- Glatiramer acetate
Unknown
Results by group
Change From Baseline in Patient-reported Treatment Satisfaction
baseline, 6 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod | 19.57 score on a scale | 21 (Standard Deviation) | 46 |
| Multiple Sclerosis Disease Modifying Treatment (MS DMT) | 5.83 score on a scale | 16.47 (Standard Deviation) | 10 |
Fingolimod
Multiple Sclerosis Disease Modifying Treatment (MS DMT)
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 | 50 | 4 (8.0%) | |
| Multiple Sclerosis Disease Modifying Treatment (MS DMT) | 11 | 1 (9.1%) |
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 Patient-reported Treatment Satisfaction
baseline, 6 months
Quality of life (reported by participants)The primary objective of the study is to evaluate the change in patient-reported treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9).
Quality of life (reported by participants)
Other measures (6)
Change From Baseline in Patient-reported Activities of Daily Living (ADL)
baseline, 6 months
Quality of life (reported by participants)Change From Baseline in Patient-reported Fatigue
6 months
FatigueQuality of life (reported by participants)Change From Baseline in Patient-Reported Effectiveness and Convenience
6 months
Quality of life (reported by participants)Change From Baseline in Patient-reported Depression
6 months
Mood and sleepQuality of life (reported by participants)Change From Baseline in Patient-reported Health Related Quality of Life (QOL)
6 months
FatiguePainQuality of life (reported by participants)Physician-reported Clinical Global Impression of Improvement (CGI-I)
6 months
Who could take part
Relapsing MS · 18 to 65 · EDSS 0 to 5.5
Show the full criteria
Inclusion criteria
* Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria. * Patients who explicitly agree to be assigned to a treatment group that may receive fingolimod or DMT after having been informed about their respective benefits and possible adverse events by the investigator. * An Expanded Disability Status Scale (EDSS) score of 0-5.5 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.
Exclusion criteria
* A manifestation of MS other than those defined in the inclusion criteria. * A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome. * History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. * Patients with uncontrolled diabetes mellitus (HbA1c > 7%). * Diagnosis of macular edema during Screening Phase. Other protocol-defined inclusion/exclusion criteria may apply
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 treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9).
Papers
Loading reviews and guidelines…
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History
Started
May 2011
Main results due
Jun 2014
Finished
Jun 2014
Results posted
Jun 2015