A Pragmatic Trial to Evaluate the Intermediate-term Effects of Early, Aggressive Versus Escalation Therapy in People with Multiple Sclerosis.
There is an unmet need to identify if specific treatment strategies during the relapsing-remitting phase of multiple sclerosis (MS) can prevent, delay, or reduce longer-term disability. Currently there is a lack of evidence-based guidelines to help clinicians and patients determine which treatment strategy is best for an individual with MS. In addition, it is unclear when people with MS, in the setting of breakthrough disease activity, should switch therapies and whether to consider a different first-line therapy or if they should escalate immediately to higher-efficacy therapies.
The TRaditional versus Early Aggressive Therapy for Multiple Sclerosis (TREAT-MS) Trial will help inform patients and the broader health care community on whether patients would most benefit from early, possibly more risky aggressive therapy or if starting with a less aggressive (and, often, less risky) therapy, followed by a switch if breakthrough disease activity occurs, is warranted. In addition, this study will help identify if there is a specific patient population or short-term biomarker(s) that is strongly predictive of long-term disability that can result from MS.
The TREAT-MS Trial is a randomized controlled trial that will recruit 900 patients across approximately 45 sites within the United States. In order to be eligible, participants must have relapsing-remitting MS and be between the ages of 18 and 60 years. Participants will need to be eligible for at least one of the higher-efficacy therapies based on screening labs. Participants are not eligible if they have had more than 6 months’ exposure to one or more MS disease modifying therapies or prior treatment with rituximab, ocrelizumab, alemtuzumab, mitoxantrone, cladribine, or an experimental aggressive therapy.
Participants that meet the eligibility criteria will initially be divided into two groups based on suspected risk(s) for long term disability. The first group will include those with “high-risk” indicators for aggressive disease versus “low-risk.” Within each group, eligible participants will be randomized 1:1, to either a “higher-efficacy” therapy (i.e., infusible therapies) versus traditional, first-line therapy (injectable and oral therapies). Participants and their neurology specialist will choose the therapy within the category that participants are randomized to that is most appropriate for them. Those deemed at low risk for disability who are initially randomized to a traditional therapy and who experience breakthrough disease activity will be re-randomized to a higher-efficacy therapy or to a different traditional therapy. An extremely important goal for any intervention is to help improve or maintain a high quality of life; therefore, in addition to classic clinical endpoints (i.e., slowing disability progression), patient reported outcomes will be obtained in order to gain a better understanding of the full impact of a treatment. Study participation will range from 42 – 54 months, depending on enrollment date and study related activities will occur around a participant’s standard of care visits.
For more information: https://clinicaltrials.ucsf.edu/trial/NCT03500328