Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Scle
Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Discontinuation of disease modifying therapy
Compared with
- Standard of Care
Results by group
Number of Participants Developing a New MS Relapse and/or MRI Brain Lesion Over the Course of the Study Duration
18-24 months, based on time of enrollment
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Drug Continuation Arm | 6 Participants | 128 | |
| Drug Discontinuation Arm | 16 Participants | 131 |
Drug Continuation Arm
Drug Discontinuation Arm
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Drug Continuation Arm | 128 | 1 (0.8%) | 1 |
| Drug Discontinuation Arm | 131 | 1 (0.8%) | 2 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Participants Developing a New MS Relapse and/or MRI Brain Lesion Over the Course of the Study Duration
18-24 months, based on time of enrollment
RelapsesMRI lesions
Other measures (19)
Number With Disability Progression Confirmed at 6 Months Using the Expanded Disability Status Scale (EDSS)
Baseline, then every 6 months for up to a maximum of 24 months, based on time of enrollment.
Disability progressionChange in Neuro-QoL (Quality of Life) Short Form Scores -- Upper Extremity Function
Baseline, 18-24 Months, based on time of enrollment
Thinking and memoryFatigueArm and hand functionMood and sleepQuality of life (reported by participants)Change in Neuro-QoL (Quality of Life) Short Form Scores -- Lower Extremity Function
Baseline, 18-24 Months, based on time of enrollment
Thinking and memoryFatigueArm and hand functionMood and sleepQuality of life (reported by participants)Change in Neuro-QoL (Quality of Life) Short Form Scores -- Fatigue
Baseline, 18-24 Months, based on time of enrollment
Thinking and memoryFatigueArm and hand functionMood and sleepQuality of life (reported by participants)Change in Neuro-QoL (Quality of Life) Short Form Scores -- Sleep Disturbance
Baseline, 18-24 Months, based on time of enrollment
Thinking and memoryFatigueArm and hand functionMood and sleepQuality of life (reported by participants)Change in Neuro-QoL (Quality of Life) Short Form Scores -- General Concerns
Baseline, 18-24 Months, based on time of enrollment
Thinking and memoryFatigueArm and hand functionMood and sleepQuality of life (reported by participants)Change in Neuro-QoL (Quality of Life) Short Form Scores -- Executive Function
Baseline, 18-24 Months, based on time of enrollment
Thinking and memoryFatigueArm and hand functionMood and sleepQuality of life (reported by participants)Change in Neuro-QoL (Quality of Life) Short Form Scores -- Communication
Baseline, 18-24 Months, based on time of enrollment
Thinking and memoryFatigueArm and hand functionMood and sleepQuality of life (reported by participants)Change in Neuro-QoL (Quality of Life) Short Form Scores -- Anxiety
Baseline, 18-24 Months, based on time of enrollment
Thinking and memoryFatigueArm and hand functionMood and sleepQuality of life (reported by participants)Change in Neuro-QoL (Quality of Life) Short Form Scores -- Depression
Baseline, 18-24 Months, based on time of enrollment
Thinking and memoryFatigueArm and hand functionMood and sleepQuality of life (reported by participants)
Who could take part
Relapsing and progressive · 55 and over
Show the full criteria
Inclusion criteria
* Patients with either Relapsing-remitting MS (RRMS), Secondary progressive MS (SPMS), or Primary progressive MS (PPMS) by McDonald 2010 criteria. * Patients defined by subtype based on 2013 updated phenotypic criteria. * Progression of MS defined by the local PI either: * prospectively with an EDSS change of at least 1.0 points over the last two years, or * retrospectively, with any significant change in motor function over at least one year, unrelated to relapse. * 55 years of age or older at time of randomization; * No evidence of recent new inflammatory disease activity (inactive by the Lublin criteria16) with no new relapse for at least five years and no new MRI lesion for at least three years * Using any of the FDA-approved MS DMTs (to include: * interferon β-1a, * interferon β-1b, * glatiramer acetate, * natalizumab, * fingolimod, * dimethyl fumarate, * ocrelizumab, or * teriflunomide; continuously for no less than 5 years. * Taking most recent DMT continuously* for no less than two years. * Willing to be randomized per this protocol; each patient will be questioned as to their willingness to stay in the trial regardless of the group to which group they are randomized. * Willing to follow the protocol * Able to undergo a brain MRI without anesthesia * Continuously will be defined as no less than 75% of all prescribed doses, with no time of greater than four weeks from last intended dose to have missed a dose (8 weeks for natalizumab, i.e. one missed dose).
Exclusion criteria
* Any MS relapse in the last five years, as determined at the screen visit by the PI * Any new or definitely enlarging T2/FLAIR lesion or new gadolinium-enhancing lesion within the past three years (at least two scans separated by at least three years must be reviewed) on brain or spine MRI scan. Lesions must be 3mm or larger to be exclusionary. * Significant (as defined by the PI) intolerance of presently-used DMT * More than two courses of acute, systemic (IV or oral) steroids in the last 5 years or any use within the last year. Course is defined as three or more days continuously, and not to exceed 14 days. No use of chronic, systemic steroids, defined as 15 or more days, in the last 5 years. Any use of steroids to treat MS relapse, possible relapse, or pseudo-relapse in the last 5 years. * Use of inhaled or topical steroids are not an exclusion criteria. * Use of oral steroids for no greater than 14 days given for a non-MS condition is not exclusionary. * Prior use of the following in the past 5 years: * alemtuzumab, * mitoxantrone, * cyclophosphamide, * methotrexate, * cyclosporine, * rituximab, * siponimod, or * cladribine * Prior use of any experimental agent used as a DMT for MS in the last five years * Other significant medical or psychiatric illness, if uncontrolled. Examples: * uncontrolled hypertension, * uncontrolled diabetes, * uncontrolled asthma, or * uncontrolled depression * Cancers other than basal cell skin cancers within the last 5 years * Unable to give informed consent or follow the protocol * Unable to undergo brain MRI * Unwilling to be randomized per this protocol * History of other chronic neurological illnesses that might mimic MS with chronic or intermittent symptoms (i.e. ALS, myasthenia gravis, chronic neuropathy, etc.)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Natural history research in Multiple Sclerosis (MS) suggests that risk of relapses and new Magnetic Resonance Imaging (MRI) changes diminish significantly as people age, especially in MS patients 55 or older. Thus, the need to continue MS medicines that reduce relapses and new MRI lesions may also decrease as people age, especially in those who have not had relapses or MRI scan changes for prolonged times. This study plans to learn more about the safety of stopping MS medication in this population, as compared to continuing on the medication.
Papers
Results
Risk of new disease activity in patients with multiple sclerosis who continue or discontinue disease-modifying therapies (DISCOMS): a multicentre, randomised, single-blind, phase 4, non-inferiority trial.Lancet Neurol · 2023
Results
Ben-Zacharia AB, Cutter G, Shor A, Morgan C, Engebretson E, Corboy J, Strauss SM. The association between BMI and cognition, disability, and quality of life markers in multiple sclerosis: DISCOMS secondary analysis. Ther Adv Neurol Disord. 2026 Aug 31;19:17562864261463625. doi: 10.1177/17562864261463625. eCollection 2026.Results
Hartung HP, Meuth SG, Miller DM, Comi G. Stopping disease-modifying therapy in relapsing and progressive multiple sclerosis. Curr Opin Neurol. 2021 Aug 1;34(4):598-603. doi: 10.1097/WCO.0000000000000960.Results
McGinley MP, Cola PA, Fox RJ, Cohen JA, Corboy JJ, Miller D. Perspectives of individuals with multiple sclerosis on discontinuation of disease-modifying therapies. Mult Scler. 2020 Oct;26(12):1581-1589. doi: 10.1177/1352458519867314. Epub 2019 Aug 1.
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History
Started
Apr 2017
Main results due
Aug 2021
Finished
Aug 2021
Results posted
Oct 2022