Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change

What Was Tested

This registered phase 4 trial tested Glatiramer Acetate for multiple sclerosis.

DMT standard of care, using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9).

It had two arms (groups): Fingolimod (experimental) and Multiple Sclerosis Disease Modifying Treatment (MS DMT) (active comparator).

Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.

The registry classes the interventions as drug.

Who Took Part

61 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: Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria. An Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive. Naïve to treatment with fingolimod.

The full record lists 5 inclusion and 5 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; diagnosis of macular edema during screening phase.

How the Study Was Run

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

The multiple sclerosis participants were allocated by chance, so the Glatiramer Acetate group and the comparison group should start out alike.

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

Everyone knew when Glatiramer Acetate was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2011-05 with completion listed for 2014-06.

It ran at 17 sites in Italy (17).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Patient-reported Treatment Satisfaction (time frame: baseline, 6 months).

It also tracked 6 secondary outcomes, for example Change From Baseline in Patient-reported Activities of Daily Living (ADL), Change From Baseline in Patient-reported Fatigue, Change From Baseline in Patient-reported Depression and Change From Baseline in Patient-reported Health Related Quality of Life (QOL).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glatiramer Acetate in 61 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.