SUMMARY
A study based at the Cleveland Clinic and the University of Nottingham (United Kingdom) is comparing two treatment strategies in 800 people with relapsing-remitting MS who have never taken a disease-modifying therapy. The study is recruiting at 30 centers in the United States and United Kingdom. One strategy is an “escalation” approach, in which individuals start taking a less-powerful therapy with the option of switching to a more potent one if disease activity continues. The other strategy involves starting with a strong therapy that is potentially more effective, but also carries greater risk for significant adverse effects. The “Determining the Effectiveness of Early Intensive versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple Sclerosis” (DELIVER-MS) Trial is funded by the Patient-Centered Outcomes Research Institute (PCORI).
DETAILS
Rationale: People with relapsing-remitting MS and neurologists are currently faced with the dilemma of adopting one of two treatment approaches: an escalation approach, starting a disease-modifying therapy that is considered safe but with a modest likelihood to control the disease activity, and escalating to more potent therapies in the face of continued disease activity; or an approach, which, in contrast, involves giving a high-efficacy therapy, with the rare potential for significant adverse effects, as the first-line treatment. Despite significant interest from both patients and care providers on this topic, there is currently no evidence comparing these two approaches in a head-to-head trial.
The DELIVER-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 “TRaditional versus Early Aggressive Therapy for Multiple Sclerosis” (
TREAT-MS). Both studies are recruiting participants.
Eligibility and Details: Investigators are seeking participants diagnosed with relapsing-remitting MS who are between the ages of 18 and 60 years. Participants are eligible if they have had MS for five years or less, and have never been treated with an MS disease-modifying therapy. Further enrollment criteria are available from the contact below.
Eligible participants will be randomly assigned into one of two groups, and will choose along with their neurology provider among options in either a first-line or higher-efficacy therapy group. Participants and their neurology specialist will choose the therapy within the category that is most appropriate for them.
During the three years that they are enrolled in the study, participants will have regular check-ups and MRI scans with their MS team, to look at the effects of treatment. They will be free to change treatment, in discussion with their neurologist, for any reason at any time.
The primary outcome being measured is the effect of treatment on brain tissue loss. Investigators will also monitor treatment effects on disability progression as measured by the EDSS scale, quality of life, other imaging measures, and safety.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please visit the study website,
www.deliver-ms.com, and you will be connected with a participating site in your area.
The following sites are enrolling in the United States:
Cleveland Clinic, Cleveland, OH
Cleveland Clinic-Las Vegas, NV
Ohio Health, Columbus, OH
University of Colorado, Anschutz Medical Campus, Aurora, CO
University of Rochester, Rochester, NY
University of Texas, Houston, TX
University of Virginia, Charlottesville, VA
Baylor College of Medicine, Houston, TX
University of Wisconsin, Madison, WI
University of Cincinnati, Cincinnati, OH
University of Minnesota, Minneapolis, MN
Mayo Clinic, Rochester, MN
University of Texas, Austin, TX
University of Buffalo, Buffalo, NY
Virginia Commonwealth University, Richmond, VA
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.