Impact of Early Aggressive vs. Standard Therapy on Disability in RRMS To Be Tested in Trial

A Johns Hopkins University-initiated clinical trial is starting to enroll an estimated 900 relapsing-remitting multiple sclerosis (RRMS) patients to assess the benefits of switching therapies to prevent or reduce disability.

The TREAT-MS study (NCT03500328) will evaluate whether RRMS patients with disease activity while on a traditional first-line disease-modifying therapy — including injectable and oral medications — should switch to another similar treatment or start on a more aggressive infusion therapy. These treatments, while considered more effective, can have more and more serious side effects.

The trial is expected to be conducted at 45 sites across the U.S, and to run for 42 to 54 months. A list of cities where enrolling study sites are planned can be found on this National Multiple Sclerosis Society webpage.

The study is one of two trials funded by the Patient-Centered Outcomes Research Institute, which aims to help inform treatment decisions regarding earlier and more aggressive treatments for MS.

RRMS patients between 18 and 60 years old who are with either newly diagnosed, or previously diagnosed but with minimal or no treatment, will be recruited. Exclusion criteria include taking one or more disease-modifying MS therapies for more than six months, or prior treatment with Ocrevus (ocrelizumab, Genentech) Lemtrada (alemtuzumab, Sanofi Genzyme) Rituxan (rituximab, Genentech), Novantrone (mitoxantrone), cladribine, or with an experimental therapy such as stem cells.

For more information on enrollment criteria, please contact the Johns Hopkins team at [email protected] to be connected with a participating site in your area.

Patients’ risk long-term disability will determine which group they will be placed in. Within each group, patients will be randomly assigned either a traditional or early aggressive therapy. Choice of therapy will be made by patients and their neurologists.

Those with a low disability risk will initially be given a traditional therapy, but it disease activity is found they could either switch to another traditional treatment or start on early aggressive medication.

Scientists will primarily focus on the time to sustained disability progression, as assessed by the Expanded Disability Status Scale (EDSS)-plus, which combines changes in either EDSS scores or the timed 25-foot walk — which tests mobility and leg function — or nine-hole peg test, which evaluates finger skills.

The team will also analyze symptoms such as mobility, fatigue, cognition, depression, and anxiety. Brain magnetic resonance imaging (MRI) scans will be performed. Patient-reported outcomes, in which patients share their perceptions of their symptoms and treatment, will also be evaluated.