EPOC
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Randomized, open-label study to evaluate patient-reported outcomes (PRO) with fingolimod after changing from prior disease-modifying therapy (DMT) for relapsing multiple sclerosis (MS): EPOC study rationale and design

Revista Abstract meeting of the 136th Annual Meeting of the American Neurological Association
Año 2011
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Estudio primario

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Summary scores for patient-reported outcome measures in multiple sclerosis. Baseline data from the trial to Evaluate Patient OutComes, safety and tolerability of fingolimod (EPOC)

Revista
Año 2012
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Estudio primario

No clasificado

Patient and physician reported outcomes after therapy switch from glatiramer acetate to fingolimod versus staying on glatiramer acetate

Revista
Año 2013
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Estudio primario

No clasificado

Improved quality of life after therapy change to fingolimod

Revista Journal of Neurology
Año 2013
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Estudio primario

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Effect of fingolimod on two sub domains of the Beck depression inventory-II In patients with relapsing multiple sclerosis

Revista Abstract meeting of the 18th Annual Conference of Rehabilitation in MS
Año 2013
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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.

Revista Journal of medical economics
Año 2013
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OBJECTIVE: The study to Evaluate Patient OutComes, Safety, and Tolerability of Fingolimod (EPOC; NCT01216072) aimed to test the hypothesis that therapy change to oral Gilenya (Novartis AG, Stein, Switzerland) (fingolimod) improves patient-reported outcomes compared with standard-of-care disease-modifying therapy (DMT) in patients with relapsing multiple sclerosis; safety and tolerability were also assessed. This communication describes the study rationale and design. METHODS: EPOC is a phase 4, open-label, multi-center study conducted in the US and Canada of patients with relapsing forms of multiple sclerosis who are candidates for therapy change. Therapy change eligibility was determined by the treating physician (US patients) or required an inadequate response to or poor tolerance for at least 1 MS therapy (Canadian patients). Patients were randomly assigned in a 3:1 ratio to 6 months of treatment with once-daily oral fingolimod 0.5 mg or standard-of-care DMTs. The primary study end-point was the change from baseline in treatment satisfaction as determined by the global satisfaction sub-scale of the Treatment Satisfaction Questionnaire for Medication. Secondary end-points included changes from baseline in perceived effectiveness and side-effects, and measures of activities of daily living, fatigue, depression, and quality-of-life. A 3-month open-label fingolimod extension was available for patients randomly assigned to the DMT group who successfully completed all study visits. RESULTS: Enrollment has been completed with 1053 patients; the patient population is generally older and has a longer duration of disease compared with populations from phase 3 studies of fingolimod. LIMITATIONS: Inclusion criteria selected for patients with a sub-optimal experience with a previous DMT, limiting the collection of data on therapy change in patients who were satisfied with their previous DMT. CONCLUSIONS: Results of the EPOC study are anticipated in early 2013 and will inform treatment selection by providing patient-centered data on therapy switch to fingolimod or standard-of-care DMTs. TRIAL REGISTRATION: ClinicalTrials.gov NCT01216072.

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Patient-and physician-reported outcomes after therapy switch from interferon (beta) to fingolimod versus staying on interferon (beta) therapy

Revista Abstract meeting of the 29th Congress of European Committee for Treatment and Research in MS
Año 2013
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Patient-reported outcomes after therapy switch to fingolimod: post-hoc subgroup analysis of the EPOC study

Revista Abstract meeting of the 66th American Academy of Neurology Annual Meeting
Año 2014
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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.

Revista Multiple sclerosis and related disorders
Año 2014
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BACKGROUND: The Evaluate Patient OutComes (ClinicalTrials.gov Identifier: NCT01216072) study was conducted in North America to assess patient- and physician-reported treatment satisfaction in patients with relapsing multiple sclerosis (MS) who received oral fingolimod for 6 months after switching from an injectable disease-modifying therapy (iDMT), without an intervening washout. METHODS: In this open-label, multicenter study, patients were randomized 3:1 to once-daily fingolimod 0.5mg or iDMT. The primary study objective was to evaluate differences in satisfaction measured using the Treatment Satisfaction Questionnaire for Medication v1.4. RESULTS: Of 1053 patients randomized, 790 patients received fingolimod and 263 patients received iDMT. Treatment satisfaction improved significantly in patients who switched to fingolimod compared with those who continued iDMT. Patients also reported significant improvements in health-related quality of life, reduced depression, and reduced fatigue severity after a switch to fingolimod. No difference between the treatment groups was detected on the Patient Reported Indices for MS Activities scale. The safety profile of fingolimod was consistent with that reported in the pivotal phase 3 studies. The most commonly reported adverse events were more prevalent in patients who switched to fingolimod than in those who continued iDMT (headache: 12% vs 3%; fatigue: 12% vs 6%). No significant relationship between lymphocyte counts and infection rates was observed and there was no evidence of additive immune-system effects, which might be expected when switching to a different class of immunomodulatory therapy with no intervening washout. CONCLUSION: Patients who switched from iDMT to fingolimod had significant improvements in most self-reported outcomes compared with those who continued iDMT.

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Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: Analyses of the EPOC trial

Revista BMC neurology
Año 2014
Enlaces Pubmed DOI PubMed Central
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Background: The Evaluate Patient OutComes (EPOC) study assessed physician- and patient-reported outcomes in individuals with relapsing multiple sclerosis who switched directly from injectable disease-modifying therapy (iDMT; glatiramer acetate, intramuscular or subcutaneous interferon beta-1a, or interferon beta-1b) to once-daily, oral fingolimod. analyses evaluated the impact of a switch to fingolimod versus staying on each of the four individual iDMTs. Methods: Overall, 1053 patients were randomized 3:1 to switch to fingolimod or remain on iDMT. The primary endpoint was the change in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction score. Secondary endpoints included changes in scores for TSQM Effectiveness, Side Effects and Convenience subscales, Beck Depression Inventory-II (BDI-II), Fatigue Severity Scale (FSS), Patient-Reported Outcome Indices for Multiple Sclerosis (PRIMUS) Activities, 36-item Short-Form Health Survey (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) and mean investigator-reported Clinical Global Impressions of Improvement (CGI-I). All outcomes were evaluated after 6 months of treatment. Results: Changes in TSQM Global Satisfaction scores were superior after a switch to fingolimod when compared with scores in patients remaining on any of the iDMTs (all <0.001). Likewise, all TSQM subscale scores improved following a switch to fingolimod (all <0.001), except when compared with glatiramer acetate for the TSQM Side Effects subscale (ρ=0.111). FSS scores were found to be superior for fingolimod versus remaining on subcutaneous interferon beta-1a and interferon beta-1b, BDI-II scores were significantly improved for fingolimod except for the comparison with intramuscular interferon beta-1a, and SF-36 scores were superior with fingolimod compared with remaining on interferon beta-1b (MCS and PCS; ρ0.030 and ρ0.022, respectively) and subcutaneous interferon beta-1a (PCS only; ρ0.024). Mean CGI-I scores were superior with fingolimod when compared with continuing treatment with any of the iDMTs (all <0.001). Conclusions: After 6 months, a switch to fingolimod showed superiority compared with remaining on each iDMT for a range of patient- and physician-reported outcomes, including global satisfaction with treatment. Trial registration: ClinicalTrials.gov.

Estudio primario

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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

Revista
Año 2014
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Estudio primario

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Outcomes of a switch to fingolimod to treat relapsing multiple sclerosis: A patient subgroup post hoc analysis

Revista Journal of Multiple Sclerosis
Año 2014
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