DOT-MS
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Interferon
What it measured
Main measures
Clinical relapses
2 years
RelapsesNew lesions on MRI-brain
2 years
MRI lesions
Other measures (14)
EDSS (Expanded Disability Status Scale)
2 years
Disability progression9-hole peg test
2 years
Disability progressionArm and hand functionTimed 25-Foot Walk
2 years
Disability progressionWalking and mobilitySymbol Digits Modalities Test
2 years
Thinking and memoryMRI-parameter: T1 post-contrast lesion number
2 years
MRI lesionsMRI-parameter: T2 post-contrast lesion number
2 years
MRI lesionsMultiple Sclerosis Impact Scale (MSIS-29)
2 years
Quality of life (reported by participants)Short Form health survey (SF-36)
2 years
Quality of life (reported by participants)Checklist Individual Strength (CIS20r)
2 years
FatiguePhysical functionTreatment Satisfaction Questionnaire for Medication (TSQM)
2 years
Quality of life (reported by participants)
Who could take part
Relapsing and progressive · 18 and over
Inclusion Criteria: * Minimum age of 18 years * Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local privacy regulations. * 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 * Complete absence of inflammatory activity (no objectively defined and confirmed relapses, no significant number (2 or more) of new-T2 lesions and no contrast-enhancing lesions) for 5 consecutive years under first-line treatment Exclusion Criteria: * A switch between first-line disease modifying therapy over two years prior to inclusion, in case the switch has been due to in effectivity of the first DMT. * 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).
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The aim of this study is to identify whether it is possible to safely discontinue treatment in relapsing-onset MS patients who have shown no evidence of active inflammation in the years prior to inclusion clinically and/or radiologically. The secondary objectives address the questions whether the discontinuation of first-line treatment has an effect on disability progression and whether the discontinuation of first-line treatment improves the quality of life for the patient. 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). In case of emerging disease activity after the cessation of therapy we will assess if reinitiation will lead to NEDA again, and if there are long-term consequences. If possible, post-hoc analysis are performed for the different types of treatment compounds.
Papers
Results
Reliability of serum neurofilament light and glial fibrillary acidic protein for detecting disease activity upon discontinuation of first-line disease-modifying therapy in stable multiple sclerosis (DOT-MS).J Neurol · 2025
Results
Discontinuation of First-Line Disease-Modifying Therapy in Patients With Stable Multiple Sclerosis: The DOT-MS Randomized Clinical Trial.JAMA Neurol · 2025
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History
Started
Jul 2020
Main results due
Aug 2023
Finished
Jan 2024
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