A study based at Johns Hopkins University is comparing two treatment strategies in 900 people newly diagnosed, or with onset/diagnosis in the past who have received minimal or no treatment, with the relapsing-remitting form of MS. The study is recruiting at approximately 45 centers nationwide. One option is an escalation approach, in which patients start taking a less-powerful therapy with the option of switching to a more potent therapy if disease activity continues. The other approach involves starting with a stronger therapy that is potentially more effective, but also carries the potential for greater risk for significant adverse effects. The “TRaditional versus Early Aggressive Therapy for Multiple Sclerosis” (TREAT-MS) Trial is funded by the Patient-Centered Outcomes Research Institute (PCORI).
: There is an unmet need to identify if specific treatment strategies during the relapsing-remitting phase of MS can prevent, delay, or reduce longer-term disability. Particularly, it is unclear whether people who experience disease activity while on a traditional, first-line disease-modifying therapy (these include injectable or oral medications for the TREAT-MS trial) should switch to a different first-line therapy or if they should escalate immediately to a higher-efficacy therapy (therapies with greater effectiveness but possibly more side effects, delivered via infusion).
The TREAT-MS Trial is one of two studies funded by PCORI that will help inform treatment decisions around whether, and which, people with MS would most benefit from early, possibly more risky aggressive therapy. The other study is Determining the Effectiveness of Early Intensive versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple Sclerosis (DELIVER-MS).
Eligibility and Details
: Investigators are seeking participants diagnosed with relapsing-remitting MS who are between the ages of 18 and 60 years. Participants are not eligible if they have had more than 6 months of exposure to one or more MS disease-modifying therapies or had any prior treatment with rituximab, ocrelizumab, alemtuzumab, mitoxantrone, cladribine, or an experimental aggressive therapy. Further enrollment criteria are available from the contact below.
Eligible participants will be divided into two groups based on whether they show characteristics that may make them at higher risk for long-term disability. Within each group, participants will be randomly assigned to either a traditional or early aggressive therapy. Participants and their neurology specialist will choose the therapy within the category that is most appropriate for them. Those deemed at low risk for disability who are initially randomly assigned to a traditional therapy and who then experience ongoing disease activity and are interested in switching therapies will be randomly assigned to a different traditional therapy or early aggressive therapy.
Study participation will range from 42 – 54 months, depending on enrollment date. Study related activities will occur around a participant’s standard visits to their local health care providers.
The primary outcome being measured is the time to sustained disability progression, as determined by the Expanded Disability Status Scale (EDSS)-plus, a combined outcome that includes change in either the EDSS or timed 25-foot walk (testing mobility and leg function) or nine-hole peg test (measuring upper extremity function). Investigators will also monitor symptoms such as fatigue, mobility, and cognition, and will track brain MRI scans. Also, patient reported outcomes – in which participants report their own perceptions about their condition -- will be obtained to gain a better understanding of the full impact of treatment.
: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please email the team at Johns Hopkins at TREATMS@jhmi.edu
and you will be connected with a participating site in your area.
Sites will be enrolling in the following cities – for currently active sites, please see the study listing on clinicaltrials.gov
Los Angeles, CA
San Francisco, CA
Kansas City, KS
Baltimore, MD (second site)
Ann Arbor, MI
Great Falls, MT
New York, NY
Stony Brook, NY
Round Rock, TX
Salt Lake City, UT
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
Without participants in research studies, MS research would come to a standstill. Read more here