Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod [amount hidden] (EPOC)

What Was Tested

In this phase 4 trial, researchers set out to test Glatiramer Acetate for multiple sclerosis.

It had two arms (groups): Fingolimod (experimental) and Standard Disease Modifying Therapy (DMT) (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 298 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Written informed consent must be obtained before any assessment is performed. Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria (McDonald et al 2001, Polman et al 2005) (Appendix 2). Male or female patients aged 18-70 years. An Expanded Disability Status Scale (EDSS) score of 0-6 inclusive. Naïve to treatment with fingolimod.

The full record lists 7 inclusion and 15 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Glatiramer Acetate and who got the comparison, which limits bias.

The Glatiramer Acetate group and the comparison group ran side by side rather than switching.

Being open-label, the Glatiramer Acetate study did not mask who received what.

It started in 2012-01 with completion listed for 2013-06.

It ran at 26 sites in Russia (26).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Patient-reported Treatment Satisfaction (time frame: Baseline, 6 months).

It also tracked 4 secondary outcomes, for example Change in Patient-reported Depression and Change in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Acute (SF-36 v2 Acute).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glatiramer Acetate in 298 people with multiple sclerosis.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Glatiramer Acetate compound page, Multiple sclerosis research.