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 |
|
| Outcomes |
Primary: MS relapse or new brain MRI lesions Secondary: change in disability, change in quality of life |
 |
2-year follow-up for primary outcome |
VIDEO (below): Helping MS Patients Get Answers
Patients are the experts on multiple sclerosis and play major roles in a PCORI-funded study about the condition.
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