Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

About 400,000 Americans have multiple sclerosis, or MS. MS is a chronic health problem that can cause fatigue, numbness, trouble with eyesight, bladder problems, and difficulty walking. With MS, the body’s immune system attacks the tissue around nerve fibers in the brain and spinal cord. When this tissue breaks down, scar tissue called lesions forms. Lesions prevent the brain from properly transmitting messages to the body. Doctors can identify these lesions using magnetic resonance imaging (MRI).

Predicting how MS will progress in each person can be hard. In early phases of MS, most people have periods of time when they have symptoms, called relapse, followed by periods of time when they have few or no symptoms, called remission. During periods of relapse, nerves can get inflamed, which can cause nerve damage.

In early phases of MS, many patients get drugs called disease-modifying therapies, or DMTs. DMTs can reduce inflammation and nerve damage. However, DMTs are less effective at treating MS in its later phases. DMTs can also be difficult to take for a long time because they are costly, can cause a variety of side effects, and have long-term health risks.

MS research suggests that risk of relapses and new lesions decreases as people age, especially in patients with MS who are 55 or older. Researchers want to learn whether patients who have had no relapse or no change in a brain MRI scan for five years can stop taking DMTs without the MS getting worse. Researchers also want to know whether there is a difference in patients’ quality of life and in how MS symptoms progress in patients who keep taking DMTs compared with patients who stop taking DMTs.

Who can this research help?

Findings from this study can help patients 55 and older with MS and their doctors decide whether to stop treatment with DMTs.

What is the research team doing?

The research team is recruiting 300 patients with MS, ages 55 and older, from 15 MS centers across the country. Patients must have had no relapse or new lesions on an MRI scan for at least five years to be eligible for the study. The team is assigning patients, by chance, to keep taking their DMT or to stop taking their DMT, with 150 people in each group. The patients and the doctors treating them know whether they are taking a DMT, but the doctors who do the brain scans and read the MRIs do not know. At any time, the patient and the patient’s doctor can decide to stop, restart, or change the DMT.

The research team is checking every six months to see whether patients have new MS activity. The team is also checking the number of new MRI lesions and changes in patients’ disabilities and quality of life.

Patients and doctors are meeting with the research team every six months to discuss study progress and provide feedback and suggestions. A patient with MS is serving on a board that monitors safety in the study.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population Adults with MS ages 55 and older who are taking a DMT, have not had a relapse or have not had new MRI lesions in 5 years, but have experienced a progression in their disease
Interventions/
Comparators
  • Discontinue taking DMT
  • Usual care, continue taking DMT
Outcomes

Primary: MS relapse or new brain MRI lesions

Secondary: change in disability, change in quality of life

Timeframe Timeframe Length of follow-up for collecting data on primary outcomes. View Glossary 2-year follow-up for primary outcome

More to Explore...

Blogs

Can Some MS Patients Safely Stop Taking Medicines?
Patients frequently ask study Principal Investigator John Corboy, MD, MA: “Hey doc, how long do I need to take this?” Studies have shown that the medicines generally become less effective as patients age. With PCORI funding, Corboy’s team is looking at two groups of patients who have stopped using their medicines and continuing treatment.

Stories and Videos

Media Mentions

 Watch the video interview

Can Aging MS Patients Stop Taking Disease-Modifying Therapies?
In a video interview with MedPage Today, study Principal Investigator John Corboy, MD, discusses new results from the study that were presented at the 2022 Annual Meeting of the Consortium of Multiple Sclerosis Centers. (Laub, MedPage Today, July 5, 2022)

Project Information

John Corboy, MD, MA
University of Colorado Denver
$6,115,558
Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)

Key Dates

September 2015
March 2023
2015

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: July 6, 2022