DOI: 10.3886/icpsr39186.v1
title: Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS), United States, 2017-2020
title: Version 1

description: 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%.
description: 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.
description: 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
description: <strong>Administrative:</strong> DS1 and DS2
<strong>Official Forms:</strong> DS3 to DS23
<strong>Outcomes:</strong> DS24 to DS30
description: None
description: Presence of Common Scales: 
Neuro-QoL (Quality of Life)
Patient Determined Disease Steps (PDDS - disability)
SymptoMScreen (overall symptom severity)
Multiple Sclerosis Impact Scale (MSIS)
Symbol Digits Modality Test (SDMT - cognition)
Expanded Disability Status Scale (EDSS)
description: 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).
description: Datasets: 
DS0: Study-Level Files
DS1: Treatment Assignment
DS2: Overall Demographics
DS3: Form 01: Demographic and MS History
DS4: Form 02: Inclusion / Exclusion Criteria
DS5: Form 03: Vital Signs
DS6: Form 04: Concomitant Medications
DS7: Form 04: Concomitant Medications (Child)
DS8: Form 05: Adverse Events and Other Reportable Events
DS9: Form 06: Neuro QoL
DS10: Form 08: Patient-Determined Disease Steps (PDDS)
DS11: Form 09: Symptom Screen
DS12: Form 10: Multiple Sclerosis (MS) Impact Scale
DS13: Form 12: Symbol Digit Modalities Test
DS14: Form 13: Relapse Assessment
DS15: Form 14: Expanded Disability Status Scale (EDSS)
DS16: Form 16: Comorbidities
DS17: Form 20: Treatment Withdrawal
DS18: Form 21: Study Withdrawal
DS19: Form 22: MRI Results
DS20: Form 25: Treatment Satisfaction
DS21: Form 26: Physical Exam
DS22: Form 28: Phone Call Assessment
DS23: Form 29: Treatment Decision
DS24: Primary Outcome
DS25: Secondary Outcomes
DS26: Other Outcomes: Multiple Sclerosis Impact Scale (MSIS)
DS27: Other Outcomes: Neuro QoL (NQL)
DS28: Other Outcomes: Patient-Determined Disease Steps (PDDS)
DS29: Other Outcomes: Symbol Digit Modalities Test (SDMT)
DS30: Other Outcomes: Symptom Screen
description: Individuals 55 years or older with Multiple Sclerosis of any sub-type.
description: on-site questionnaireStudy sites listed in the documentation can not be linked to the variable <strong>SITE</strong> in the data files.The letters and numbers within the variable <strong>SCREENING_ID</strong> 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 <strong>RANDOMIZED_ID</strong> 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.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.