Project Summary

PCORI has identified multiple sclerosis (MS) as an important research topic. Patients, clinicians, and others want to learn how different treatment strategies, aimed at changing specific symptoms or the overall course of MS, affect patients’ symptoms and quality of life.  To address this issue, PCORI launched a funding initiative in 2015 on Treatment of Multiple Sclerosis. This research project is one of the studies PCORI awarded as part this program.

COVID-19-Related Project Enhancement

The enhancement seeks to evaluate whether patients with multiple sclerosis (MS) enrolled in the TREAT-MS study delayed or altered the schedule of planned treatment with disease-modifying therapies during the COVID-19 pandemic and whether any delays varied across treatment approach (early intensive versus escalation approach).

Further, the study team will determine whether variations in treatment schedule were associated with a higher likelihood of breakthrough disease activity and/or worsening MS symptoms. The team will also examine whether patients with MS treated with higher efficacy versus traditional therapies differ in their risk of severe COVID-19 infection or mortality.

Enhancement Award Amount: $728,567

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?

Multiple sclerosis, or MS, is a serious long-term health problem that affects more than 400,000 people in the United States. MS affects the brain and spinal cord. Symptoms include muscle weakness, trouble with coordination and balance, and thinking and memory problems. MS is a leading cause of disability among young adults in the United States. There is no cure for MS, but treatment can help manage symptoms.

Most people with MS have periods of new or worsening symptoms, called relapses, followed by periods of few or no symptoms, called remission. As MS goes on, symptoms slowly get worse without periods of getting better. Early symptoms may include trouble seeing, numbness, or weakness. Over time, patients may have a hard time walking and need a wheelchair.

In the early stages of MS, patients may take standard, first-line medicines to prevent relapses. Some aggressive medicines work better than first-line medicine for reducing relapse. However, aggressive medicines may cause serious side effects, such as higher risk of infections, autoimmune problems, cancers, and liver failure. Doctors don’t know if either method is better for preventing long-term MS disability. This study is comparing standard medicines versus aggressive medicines on delaying MS from reaching the stage where symptoms continue to get worse and lead to disability.

Who can this research help?

Patients with MS and their doctors can use findings from the study to better understand the risks and benefits of using stronger medicines to prevent or delay disability.

What is the research team doing?

The research team is enrolling 900 adults with MS at approximately 45 study sites throughout the United States and following up with them for up to 4.5 years. The team is assigning patients by chance to one of two groups. Half receive standard medicines, and half receive aggressive medicine. The study is comparing the overall effects of these classes of medicine on disability risk. The team is also looking at whether the medicines’ effect on future disability depends on whether patients are at high or low risk for disability at the start of the study.

The team is tracking patients who are at low risk for disability, but who have a relapse or changes on brain scans that suggest that the first medicine isn’t working well. The team reassigns these patients by chance to get either a different standard medicine or an aggressive medicine.

To assess differences in how often patients develop disability during early stages of MS, the team is following patients over time. The team is also tracking differences between groups in quality of life and disabling symptoms such as fatigue, and thinking and memory problems. To track disease progression, the team is using brain scans.

An advisory committee of people with MS, doctors, statistics experts, and patient advocacy groups is giving input on study design.

Research methods at a glance

Design Element

Description

Design Randomized controlled trial
Population Adults ages 18–60 years with relapsing-remitting MS who did not receive chemotherapy previously or take specific MS medicines for a long period of time

Interventions/Comparators

  • Standard medicines (self-injected and oral therapies)
  • Early aggressive medicines (infusible medicines)
Outcomes

Primary: long-term disability as assessed by neurologic examinations

Secondary: patient-reported disability, fatigue, health-related quality of life

Timeframe Up to 4.5 years of follow-up for primary outcome

More About This Research

Videos

Helping Clinicians Prescribe the Right Therapies for Patients with MS
Principal Investigator Ellen Mowry speaks about this study's aims to provide clarity for clinicians on which disease modifying therapy should be prescribed for patients living with multiple sclerosis.

 

Project Information

Ellen M. Mowry, MD
Scott Newsome, DO
Johns Hopkins University
$14,735,373

Key Dates

60 months
September 2017
November 2025
2017

Study Registration Information

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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.

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Last updated: November 15, 2021