Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS), United States, 2017-2020 (ICPSR 39186)
Version Date: Jul 1, 2025 View help for published
Principal Investigator(s): View help for Principal Investigator(s)
John Corboy, University of Colorado-Denver
https://doi.org/10.3886/ICPSR39186.v1
Version V1
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Summary View help for Summary
This study was a multicenter, randomized, controlled, rater-blinded, phase 4, non-inferiority trial. Individuals with multiple sclerosis of any subtype, 55 years or older, with no relapse within the past 5 years or new MRI lesion in the past 3 years while continuously taking an approved disease-modifying therapy were enrolled at 19 multiple sclerosis centers in the USA. Participants were randomly assigned (1:1 by site) with an interactive response technology system to either continue or discontinue disease-modifying therapy. Relapse assessors and MRI readers were masked to patient assignment; patients and treating investigators were not masked. The primary outcome was percentage of individuals with a new disease event, defined as a multiple sclerosis relapse or a new or expanding T2 brain MRI lesion, over 2 years. The study assessed whether discontinuation of disease-modifying therapy was non-inferior to continuation using a non-inferiority, intention-to-treat analysis of all randomly assigned patients, with a predefined non-inferiority margin of 8%.
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Restrictions View help for Restrictions
Access to the data in this collection is restricted. Users interested in obtaining these data must complete a Restricted Data Use Agreement, specify the reason for the request, and obtain IRB approval or notice of exemption for their research.
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Data Collection Notes View help for Data Collection Notes
- Study sites listed in the documentation can not be linked to the variable SITE in the data files.
- The letters and numbers within the variable SCREENING_ID are not tied directly to a respondent's personal information. This ID was assigned to a participant during the screening / enrollment phase of data collection. The variable RANDOMIZED_ID was assigned once a participant was randomized into the study. Participants who were screened but not randomized were excluded from the deposited data files. These variables can be used to link participant's across data files.
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The questionnaires (forms) were annotated by the Principal Investigator. They should be used in conjunction with the data file and codebook to align variables to understand what each means.
Study Purpose View help for Study Purpose
The purpose of this study was to investigate whether older patients with Multiple Sclerosis (MS) with no recent signs of new inflammatory disease activity could safely discontinue Disease Modifying Therapy (DMT) with no greater risk of new relapses compared to those who stayed on their DMT.
Study Design View help for Study Design
Please refer to Section B on page 6 of the included Protocol document for criteria for inclusion and exclusion from this study (see also dataset 3). Basic inclusion criteria required the person be 55 years old or older, free of new inflammatory disease for five years, currently using a FDA approved Multiple Sclerosis Disease Modifying Therapy (MS DMT), and able to undergo a brain MRI (magnetic resonance imaging).
Patients were randomized to either continue with their present MS DMT (control) or discontinue their present DMT (experimental). There was no placebo treatment given, nor was there a taper period of discontinuation. Enrolled participants were seen five times: baseline, 6 months, 12 months, 18 months, and 24 months
Sample View help for Sample
At each of the 19 study sites charts were reviewed to identify eligible patients. These potential study participants were then approached by their primary neurologist and/or the study coordinator regarding participation in the study. This person(s) then verified inclusion / exclusion criteria and answered questions prior to enrolling the patient in the study. Patients were randomized 1:1 into either the control or experimental group. There was a goal to get 136 patients enrolled in each group and complete the study. There were 128 patients who were randomized into the control group (continue DMT), and 131 patients randomized into the experimental group (discontinue DMT).
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Universe View help for Universe
Individuals 55 years or older with Multiple Sclerosis of any sub-type.
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Original Release Date View help for Original Release Date
2025-07-01
Version History View help for Version History
2025-07-01 ICPSR data undergo a confidentiality review and are altered when necessary to limit the risk of disclosure. ICPSR also routinely creates ready-to-go data files along with setups in the major statistical software formats as well as standard codebooks to accompany the data. In addition to these procedures, ICPSR performed the following processing steps for this data collection:
- Checked for undocumented or out-of-range codes.
Notes
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