Research
The focus of research in the Multiple Sclerosis and Neuroimmunology Unit is immune disorders of nervous system. In particular our research includes cutting-edge clinical research and experimental therapeutics of multiple sclerosis.
Scope of Research: Multiple Sclerosis and other Immune Disorders of the Central Nervous System
The current focus is cutting-edge clinical research and experimental therapeutics of multiple sclerosis.
- Clinical research assessing novel immunotherapies targeted at multiple steps in the pathogenesis of MS lesions
- Clinical research evaluating new symptomatic therapies
- Clinical research studies of fatigue, cognitive dysfunction, and other aspects of MS
Andrew D. Goodman, M.D., Director
Andrew_Goodman@urmc.rochester.edu
(585) 275-7854
Current Research:
Ongoing Trials - Closed to Enrollment
FENtrepid – A Phase III Multicenter, Randomized, Double-Blind, double-Dummy, Parallel Group Study to Evaluate the Efficacy & Safety of Fenebrutinib compared with Ocrelizumab in Adult Patients with PPMS.
A study to evaluate the efficacy and safety of fenebrutinib compared with Ocrelizumab on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). Participants will receive both oral investigational product and infusions; one treatment will be active and one will be placebo. Study assessments include MRIs, patient questionnaires, bloodwork, and clinical evaluations of MS.
https://www.clinicaltrials.gov/ #NCT04544449
DELIVER-MS – Determining the Effectiveness of early Intensive Versus Escalation approaches for the treatment of Relapsing-Remitting Multiple Sclerosis.
This study enrolled adult men and women aged 18 to 60 years, with an established diagnosis of Relapsing, Remitting Multiple Sclerosis as defined by the 2017 McDonald Diagnostic Criteria. Enrolled participants were ambulatory, EDSS ≤ 6.5, with disease onset ≤ 5 years and they were treatment naïve. Our team enrolled 27 subjects. We are also participating in a Long Term Extension Study to follow these subjects for an additional 3 years.
https://www.clinicaltrials.gov/ #NCT03535298
PASS-Lemtrada – A prospective, multicenter, observational, post-authorization safety study to evaluate the long term safety profile of LEMTRADA® (alemtuzumab) treatment in patients with relapsing forms of multiple sclerosis.
Upcoming and Currently Enrolling Trials
SPRINT-MS Follow-on Study – Validating Magnetic Resonance Imaging Biomarkers in Progressive Multiple Sclerosis
Follow up on a study that was completed >8 years ago. The original study was the Sprint MS Ibudilast trial for Progressive MS. All subjects will be invited to return to the clinical center for a single clinical visit where disability measures will be performed and Patient-Reported Outcomes will be collected. This is a biomarker validation study and, thus, involves no interventions. MRIs from the original study will be assessed to see if they can help predict the clinical outcomes of disease progression as they present in the long term follow up. The sponsor is interested in understanding and overcoming obstacles in conducting long term follow up studies in progressive MS.
Extinguish – (Encephalitis Treatment with Inebilizumab for NMDAR and GUIdance on Serum + CSF biomarkers to predict HEALTH outcomes)
There are currently no medicinal products approved for the treatment of NMDAR encephalitis, a rare autoimmune disease. There is a high unmet need for more effective therapies. This study aims to define the efficacy and safety of inebilizumab in reducing the level of disability in patients with NMDAR encephalitis. Participants will receive inebilizumab infusions or placebo in addition to first-line therapies.
AMS05 – Randomized, Blinded Discontinuation Trial of Ocrelizumab in Early Relapsing Multiple Sclerosis
This 4+ year trial aims to evaluate the rate of durable remission of relapsing disease activity in participants with early relapsing MS who receive Ocrelizumab infusions for either 1, 2, or 4 years. Study assessments include MRIs, patient questionnaires, blood work, and clinical evaluations of MS.
https://www.clinicaltrials.gov/ #NCT05285891
Recently Completed Projects
MSPATHS and Biobanking Studies – MS PATHS was a collaborative project with sites in both the US and Europe which collected de-identified data on MS patients. Over 20,000 patients enrolled in the project across the different sites. Here at URMC we enrolled 2000 patients in the parent study with over 400 patients participating in the Biobanking study. The data and Biobank samples are housed here at URMC.
MSPATHS – Multiple Sclerosis Partners Advancing Technology and Health Solutions