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Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS), United States, 2017-2020 (ICPSR 39186)

Released/updated on: 2025-07-01

Geographic coverage: United States

Time period: 2017-01-01--2020-01-01

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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Reduction of Health Disparities in Appalachians with Multiple Cardiovascular Disease Risk Factors: A Randomized Controlled Trial, 2013-2016 (ICPSR 36985)

Released/updated on: 2018-02-09

Geographic coverage: United States, Kentucky

Time period: 2013-01-01--2016-01-01

This study consists of a two-group, randomized, controlled comparative effectiveness trial with 300 individuals from Appalachian Kentucky who do not have a primary care provider (and thus are not able to receive the standard of care without intercession) and who are at risk for CVD (cardiovascular disease) by virtue of having two or more modifiable CVD risk factors. The researchers compared (1) the standard of care alone, referral to a primary care provider for management of CVD risk factors, with (2) standard of care supplemented by patient-centered, culturally appropriate, self-care CVD risk reduction intervention (HeartHealth) designed to improve multiple CVD risk factors while overcoming barriers to success.

The researchers compared the 4 month (short-term) and 1 year (long-term) impact of the interventions on: 1) CVD risk factors selected by patients (i.e., tobacco use, blood pressure, lipid profile, HgA1c for diabetics, body mass index, waist circumference, depressive symptoms, or physical activity level); 2) all CVD risk factors for each patient; 3) quality of life; 4) patient and healthcare provider satisfaction; 5) desirability and adoptability by assessing adherence to recommended CVD risk reduction protocols, and retention of recruited individuals.

Demographic variables include gender, age, ethnicity, marital status, employment status, and level of education.