Neuroimmunology Research
Research through clinical studies and trials are made available to patients and families in collaboration between UMass Chan Medical School and UMass Memorial Medical Center. The MS Clinic administers patient restorative care and evaluations under the clinical trial treatments and specialized patient care. Patients with Relapsing Remitting, Secondary Progressive, and Primary Progressive MS are provided the opportunity to enroll in clinical trials through the Neuroimmunology and MS Center. The trials provided by UMass Chan and UMass Memorial Health Care are designed to prevent the future worsening of MS, and improve the quality of life of our patients.
Neurology research based Clinical trials are located on the UMass Memorial Medical Center's Neurology Research and Clinical Trial Studies.
For more information regarding our clinical trials, please reach out to our research coordinators.
TREAT-MS - “The Traditional versus Early Aggressive Therapy for MS (TREAT-MS) trial is a pragmatic, randomized controlled trial that has two primary aims, to evaluate the Intermediate-term Effects of Early Aggressive Vs Escalation Therapy in People with Multiple Sclerosis.: 1) to evaluate, jointly and independently among patients deemed at higher risk vs. lower risk for disability accumulation, whether an "early aggressive" therapy approach, versus starting with a traditional, first-line therapy, influences the intermediate-term risk of disability, and 2) to evaluate if, among patients deemed at lower risk for disability who start on first-line MS therapies but experience breakthrough disease, those who switch to a higher-efficacy versus a new first-line therapy have different intermediate-term risk of disability.”
ClinicalTrials.gov Identifier: NCT03500328
Current status: Active; Enrolling patients
Open to: Patients with early relapsing MS.
PI: Carolina Ionete, MD, PhD
BEAT-MS Study - This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy Vs. Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (Phase I)
Sponsor: ITN/NIH.
ClinicalTrials.gov Identifier: NCT04047628
Current status: Active; Enrolling patients
Open to: Patients with highly active treatment-resistant relapsing MS.
PIs: Carolina Ionete, MD, PhD
Conquering Diseases - Trial
The FSDD Study - (Family Study of Demyelinating Disorders) is our Center’s longitudinal repository of biosamples established in 2012 by Dr. Ionete, in which volunteers donate samples of blood, DNA, CSF, stool, hair, and/or urine to contribute to the discovery of novel biomarkers in MS. All the samples are associated with clinical and MRI data sets. The aims of this project include novel exploration of biomarkers of disease mechanism, prognosis, personalized medicine and treatment response. Many of the samples were used for collaborative work finalized with multiple publications. Sponsor: UMMHC MS Center/ITN/NIH.
ClinicalTrials.gov Identifier: UMass IRB 14143
Current status: Active; Enrolling patients
Open to: Any MS patient that has CSF or blood studies. Patients with all types of MS, neuroinflammatory disease, other neurological diseases, healthy control, and families of MS patients.
PI: Carolina Ionete, MD, PhD
OPTIMUM Study - (the Observational Platform To Investigate Multiple sclerosis at the University of Massachusetts) is our large, longitudinal registry database of persons with MS and neuroinflammatory diseases at UMass. We encourage all patients to enroll and contribute to this valuable resource, which we are using to improve care and pioneer the discovery of new MS biomakers and potential treatments. Funding: UMass Memorial Medical Center; MS Center.
ClinicalTrials.gov Identifier: UMass IRB H00016906
Current status: Active; Enrolling patients
Open to: Any MS patient that has CSF or blood studies. Patients with all types of MS and neuroinflammatory disease.
PI: Christopher Hemond, MD
Conquering Diseases - Trial
SOMNUS Study - Sleep/apnea in MS: is a study examining the role of sleep apnea in MS fatigue and disability of MS patients. This study will evaluate the influence of sleep apnea on clinical and radiological features of MS.
Funding: National Multiple Sclerosis Society
ClinicalTrials.gov Identifier: UMass IRB BibMC cci 2019P000494
Current status: Active; Enrolling patients
Open to: Patients with all types of MS. All MS patients irrespective of sleep apnea status
PI: Idanis Berrios Morales, MD
Conquering Diseases - Trial
PERSEUS Study - An Investigational Drug For Primary Progressive Multiple Sclerosis
A Phase 3, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with PPMS. We are studying whether the investigational drug is safe and effective in preventing disability progression for people with primary progressive multiple sclerosis. Participants in this study will be randomly assigned to receive either the investigational drug or a placebo (looks like the drug but contains no medicine). Twice as many people will be assigned to the investigational drug than the placebo. Participants will have monthly office visits for the first 9 months of the study and then office visits every 3 months for the rest of the study.
ClinicalTrials.gov Identifier: NCT04458051
Current Status: Active; Enrolling patients
PI: Roberto Bomprezzi, MD, PhD
Conquering Diseases - Trial
GN Study - A Study Looking At An Investigational Drug In Adults With Relapsing Multiple Sclerosis
focuses on evaluating the effects of fenebrutinib versus teriflunomide and it's safety and benefit to patients with RMS.
ClinicalTrials.gov Identifier: NCT04544449
Current status: Active; No longer enrolling patients
Open to: Patients with relapsing multiple sclerosis (RMS).
PI: Carolina Ionete, MD, PhD
Conquering Diseases - Trial
ImStem Study - Of An Investigational Drug For Multiple Sclerosis
focusing on how well an investigational drug for multiple sclerosis is tolerated at increasing doses. Focuses on evaluating whether an experimental drug infused at one of three different dose strengths is safe and effective for multiple sclerosis (MS) that has not responded to previous treatment. This study works with participants with multiple sclerosis (MS) that hasn't responded to previous treatment for a study of an experimental drug.
ClinicalTrials.gov Identifier: NCT04956744
Current Status: Active, No longer enrolling patients
Open to: Patients willing to test a drug that has not yet been tested in people.
PI: Carolina Ionete, MD, PhD
Conquering Diseases - Trial
AGNOS Study - To Determine Whether A Drug Is Safe And Effective In People With Early Multiple Sclerosis
To evaluate the safety and effectiveness ofatumumab in participants with early relapsing forms of multiple sclerosis compared to healthy controls. We are studying the effect of an investigational drug called ofatumumab and whether it is safe and effective for participants with early relapsing forms of multiple sclerosis. This will be done through injection of the drug, blood tests, imaging, questionnaires, and other assessments.
ClinicalTrials.gov Identifier: NCT05084638
Current Status: Active; No longer enrolling patients
Open to: Patients with early MS (Agnos).
PI: Raffaella Umeton, MD
Conquering Diseases - Trial
MBSR Study - Mindfulness Based Stress Reduction in MS is an observational trial of persons who participate in the rigorous MBSR course offered through the UMass Center for Mindfulness. Volunteers will undergo blood tests, hair cortisol measurements, MRI scans, and answer questionnaires about aspects of their quality of life in order to determine potential effects of this intervention on the brain and immune system. Funding: Multiple Sclerosis Foundation; Consortium of MS Centers.
ClinicalTrials.gov Identifier:
Current status: Active; No longer enrolling patients
Open to: Patients with all types of MS; only persons who have never taken MBSR before
PI: Christopher Hemond, MD
Conquering Diseases - Trial
BN Study - A Study Of An Investigational Drug In Adults With Primary Progressive Multiple Sclerosis
focuses to evaluate the safety and efficacy of higher doses of ocrelizumab in patients with primary progressive multiple sclerosis (PPMS) and whether a higher dose can slow down the progression and worsening of PPMS.
ClinicalTrials.gov Identifier: NCT04548999
Current Status: Active; No longer enrolling patients
PI: Carolina Ionete, MD, PhD
Conquering Diseases - Trial
OCARINA Study - To evaluate the pharmacokinetics, safety and tolerability, and immunogenicity of ocrelizumab administered subcutaneously to patients with multiple sclerosis (MS).
ClinicalTrials.gov Identifier: NCT03972306
Current status: Active; No longer enrolling patients
PI: Carolina Ionete, MD, PhD
Shared Decision-Making in MS: is a research study examining the needs of patients with Multiple Sclerosis during the discussion with their physicians about their MS Care as well as treatments. Volunteers will undergo an in-person interview to know their experience during diagnosis and management of their MS. Their experience during the decision process to start or change medication and how decisions are made. The goal is to create a tool to improve communication between patients and physicians.
ClinicalTrials.gov Identifier: Not Available
Current status: Active; No longer enrolling patients
Open to: Relapsing-Remitting Multiple Sclerosis
PI: Idanis Berrios-Morales, MD
CLICK-MS Study - focuses on evaluating “the effectiveness and safety of cladribine tablets in participants with RMS including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS),who transition to cladribine tablets after suboptimal response to any injectable DMD approved in the United States (US) for RMS in a real-world setting.”
ClinicalTrials.gov Identifier: NCT03933215
Current status: Closed
PI: Idanis Berrios-Morales, MD
Conquering Diseases - Trial
Evolutionary MS Study - Of An Investigational Drug For Relapsing Multiple Sclerosis
To studying whether an investigational drug is safe and effective in reducing relapses compared to the standard drug for relapsing multiple sclerosis.
ClinicalTrials.gov Identifier: NCT04338022
Current Status: Closed
PI: Idanis Berrios-Morales, MD, Carolina Ionete, MD, PhD
Conquering Diseases - Trial
MASTER-2 Study - focuses on evaluating “the effectiveness and safety of cladribine tablets in patients with RMS, including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS), who transition to cladribine tablets after suboptimal response to any other oral disease-modifying drugs (DMDs) or any infusion DMDs approved in the United States (US) for RMS in a real-world setting.”
ClinicalTrials.gov Identifier: NCT03933202
Current status: Closed
PI: Idanis Berrios-Morales, MD
Conquering Diseases - Trial
Microbiome in MS Study - is a research study examining the correlation of gut microbiome composition in patients with different types of MS and on different disease modifying therapies. In collaboration with Drs. Beth McCormick, Doyle Ward and Ana Maldonado-Contreras from the UMass Center for Microbiome Research.
ClinicalTrials.gov Identifier: Not Available
Current status: Closed
PI: Raffaella Umeton, MD MMSc / Carolina Ionete, MD, PhD
Verismo Study - The Long Term Safety Of Ocrelizumab Treatment For People With Multiple Sclerosis (Ms) We are studying whether people who are being treated with ocrelizumab for their Multiple Sclerosis (MS) are more or less likely to be diagnosed with cancer in the future by periodically looking at their medical records. We will compare the medical records of people getting ocrelizumab treatment with people whose MS is being treated with other therapies.
ClinicalTrials.gov Identifier: WIRB 20191675
Current Status: Closed
PI: Roberto Bomprezzi, MD, PhD
Conquering Diseases - Trial
Epstein-Barr Virus (EBV) in MS is a research study examining the immune system’s response to EBV. Although mostly associated with infectious mononucleosis (“mono”), this virus has been found to be universally present in persons with MS. Together with our colleagues in the immunology department, we are testing a leading scientific hypothesis that MS may arise from an abnormal immune system response to this virus. In collaboration with Drs. Liisa Selin and Anna Gil (UMass Pathology department ) we are examining Epstein-Barr virus (EBV)-specific immunodominance hierarchies and T cell receptor (TCR) repertoires in three stages of MS disease: relapsing-remitting, primary progressive and secondary progressive MS over time in comparison to healthy donors. Our studies provide insight into mechanisms operative in selection of memory CD8 TCR repertoires in the presence of persistent virus and examining their role in MS pathogenesis. Improved understanding of EBV-specific immune responses could facilitate prophylactic vaccine development or novel immunotherapies to modulate CD8 T-cell mediated immunopathologic condition during primary infection and autoimmune disorders such as MS. Funding: National MS Society, UMass Memorial Medical Center.
ClinicalTrials.gov Identifier: Not Available
Current status: Closed
Open to: All types of MS
PI: Christopher Hemond, MD, Liisa Selin, MD, PhD
Registry To Study Genetic Origins Of Multiple Sclerosis
by better understanding the genetic origins of this disorder, and other similar diseases, we may identify potential new targets for treatment. We are collecting biological samples and medical information from volunteers who have Multiple Sclerosis (MS) and from family members who do not have MS for testing to see if there may be a genetic or environmental risk factor for MS and perhaps improve treatments for MS.
ClinicalTrials.gov Identifier: WIRB 20183136
Current Status: Active; Enrolling patients
Open to: Patients with MS and/or their family members.
PI: Carolina Ionete, MD, PhD
Conquering Diseases - Trial