Currently enrolling patients in the following clinical trials:
1) A randomized controlled trial of vitamin D supplementation in multiple sclerosis (Click the link for more study information)
2) A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of TecfideraTM (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM):
Dr. Ellen Mowry is currently recruiting subjects for a study that will collect information on safety and document the drug utilization of Tecfidera (dimethyl fumarate) when used in patients with multiple sclerosis (MS). This study is being done to gain a better understanding of the benefits and risks of long-term treatment with Tecfidera in individuals with MS.
Participants with MS who are newly starting treatment with Tecfidera as part of routine clinical care will be enrolled and followed for up to five years. Information on safety, side effects, relapses, disability progression, and the quality of life in individuals taking Tecfidera will be collected. Participants are not expected to come to Johns Hopkins for visits other than those already scheduled with their MS clinical provider.
In order to be eligible, participants must have MS and be planning to start Tecfidera soon. Participants must not have previously received Tecfidera (dimethyl fumerate), Fumaderm, or compounded fumarates at the time of enrollment.
For more information, please contact Haley Rue at firstname.lastname@example.org
Protocol Number: IRB00030761
Multi-Center Clinical Trials of New Treatments for Multiple Sclerosis Overview:
Several new treatments for multiple sclerosis (MS) have been successfully developed over the last decade. Each of these drugs has had to undergo extensive investigation before obtaining approval for general use.
The testing of new multiple sclerosis therapies is typically done in large clinical trials and is often the culmination of many years of prior laboratory-based research and development. Occasionally, the Multiple Sclerosis Center at Johns Hopkins will offer patients the opportunity to participate in clinical trials that are designed to test the effectiveness of new forms of therapy. Clinical trials are voluntary, and our team will only involve patients who are entirely comfortable with the process.
All clinical trials conducted here at Johns Hopkins are approved and closely monitored by the University’s Institutional Review Board. None of our MS clinic faculty have any financial interests or holdings in the various pharmaceutical companies who produce drugs used to treat MS.
The treatment paradigm in MS is changing to include drugs with new mechanisms of action, intermittent dosing schedules and differing drug delivery systems. Several pharmaceutical and biotech companies have ongoing or recently completed trials of promising new treatments for relapsing forms of multiple sclerosis. Oral medications are moving closer to FDA approval. The Johns Hopkins Multiple Sclerosis Center is playing a central role in the development of several of these agents.
The phase III clinical trial of Fingolimod, a new oral agent from Novartis, was recently completed and the results indicate a positive effect on relapses, disability outcomes and MRI outcomes. Dr. Calabresi is the principal investigator of this trial for the Johns Hopkins MS Center and recently co-authored the New England Journal of Medicine publication describing the trial outcomes.
In addition to Fingolimod, several monoclonal antibodies are in clinical trials, including rituximab and ocrelizumab. Both of these agents target B-cells, another type of lymphocyte found to be an important player in the immunopathology of MS. Dr Calabresi serves on the national steering committees for both of these trials.