Discontinuing Disease-modifying Therapies in Stable Relapsing - Onset Multiple Sclerosis (DOT-MS).

What Was Tested

The trial (not phased) is built around Glatiramer Acetate for multiple sclerosis.

Furthermore, blood collections will be included to assess whether it is possible to retrospectively predict possible return of inflammatory activity with biomarkers such as neurofilament light (NFL) or patient characteristics such as disease activity prior to disease modifying therapy (DMT).

It had two arms (groups): Discontinuation of DMT (experimental) and Continuation of DMT (no intervention).

Discontinuation of first-line disease modifying therapy (any of the interferons, glatiramer acetate, dimethylfumarate, teriflunomide).

Continuation of first-line disease modifying therapy (any of the interferons, glatiramer acetate, dimethylfumarate, teriflunomide).

The registry classes the interventions as drug.

Who Took Part

The registry lists 130 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Minimum age of 18 years. Definite diagnosis of relapsing-onset MS according to the revised McDonald 2017 criteria. Treatment with one of the first-line DMTs: any of the interferons, glatiramer acetate, dimethylfumarate, teriflunomide.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: women who want to discontinue medication because of a pregnancy wish and women who are pregnant or expect to become pregnant during the study period; patients that have previously used interferon-beta and have been tested positive for neutralizing antibodies (nabs).

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

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.

In this single-blind Glatiramer Acetate study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2020-07-01 with completion listed for 2023-08-01.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Clinical relapses (time frame: 2 years). New lesions on MRI-brain (time frame: 2 years).

It also tracked 14 secondary outcomes, for example EDSS (Expanded Disability Status Scale), 9-hole peg test, Timed 25-Foot Walk, Symbol Digits Modalities Test, MRI-parameter: T1 post-contrast lesion number and MRI-parameter: T2 post-contrast lesion number.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glatiramer Acetate in 130 people with multiple sclerosis.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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