NEUROIMMUNOLOGY (MS) RESEARCH

Rocky Mountain MS Center (RMMSC) Biorepository for the Study of Neuroimmunological Disorders (12-0968)

• Investigator: Enrique Alvarez, MD, PhD
• Purpose: Investigating the causes of MS and similar diseases. Investigating new and existing drugs/treatments for MS. Seeking to find new treatment strategies.
  
• Timeline: Biospecimen collections occur at the patient’s regularly scheduled visits with their MS provider.
  
• Key Eligibility Criteria:
  • Going off DMT 
  • Newly diagnosed patients 
  • Active relapse

DREAMS (19-0393)   

• Investigator: Teri Schreiner, MD, MPH  
• Purpose: to learn more about the risk factors for and causes of MS by studying children who are first degree relatives of people with MS.
• Timeline: a single 3-4 hour study visit (includes MRI and blood draw).
• Key Eligibility Criteria:
  • Age 10-17 years old
  • Have parent or sibling with MS
  • No diagnosis of MS or early symptoms of MS

RISE-MS (17-1884)   

• Investigator: Enrique Alvarez, MD, PhD and John Corboy, MD 
• Purpose: to learn more about the risk factors for and causes of MS by studying first degree relatives of people with MS  
• Timeline: a single 2-3 hour study visit (includes MRI and blood draw).
• ClinicalTrials.gov Identifier: NCT03586986 
• Key Eligibility Criteria:
  • Age 18-30 years old
  • Have parent or sibling with MS
  • No diagnosis of MS or early symptoms of MS
    

Spinal Fluid Biomarkers in First-Degree Relatives of Patients with Multiple Sclerosis (MS)   

• Investigator: Enrique Alvarez, MD, PhD
  
• Purpose: Investigating Spinal Fluid Biomarkers in First-Degree Relatives of Patients with Multiple Sclerosis. Involves LP and an additional blood draw.
  
• Timeline: Biospecimen collections occur at the patient’s regularly scheduled visits with their MS provider.
  
• Key Eligibility Criteria:
  • Age 18-30 years old
  • Have parent or sibling with MS
  • No diagnosis of MS or early symptoms of MS

BlossoMS

• Investigator: Anna Shah, MD 
• Purpose: This national pregnancy registry includes women with MS who have taken Vumerity® (diroximel fumarate) during pregnancy, as well as MS patients not on DMT during pregnancy, to evaluate infant outcomes.
  
• Timeline: If you take part in the registry, information will be collected during pregnancy and until your baby is 12 months old.
  
• Key Eligibility Criteria:
  • RMMS diagnosis
  • Treatment with Vumerity® during pregnancy or no DMT treatments during pregnancy
    

Biomarkers in Pregnancy

• Investigator: Anna Shah, MD 
• Purpose: Evaluating changes in biomarkers that occur during pregnancy and postpartum. prior to conception.
  
• Timeline: Participation takes place during and after a pregnancy at regular provider visits.
  
• Key Eligibility Criteria:
  • MS diagnosis
  • Able to have 2 blood draws during pregnancy and 2 postpartum

Currently Enrolling Studies

BEAT-MS (19-1621)

• Investigator: John Corboy, MD  
• Purpose: to compare efficacy and safety of autologous hematopoietic stem cell transplantation (AHSCT) to best available therapy (BAT) in treatment resistant relapsing MS.  
• Intervention: best available therapy (50% chance) or AHSCT cell transplant (50% chance).
• Timeline: up to 17 study visits over 6 years (not including stem cell transplantation procedures, if randomized to AHSCT group).
• ClinicalTrials.gov Identifier: NCT04047628  
• Key Eligibility Criteria:
  • Age 18-55 years old
  • Diagnosis: highly active, treatment resistant MS
  • 2 clinically confirmed episodes of treatment failure in the past 36 months
  • Insurance or public funding available to cover the cost of an MS DMT
    

CAREinMS

• Investigator: Teri Schreiner, MD, MPH
• Purpose: To learn how adversity in childhood might affect MS in various populations including Black, Hispanic, low-income, and others.
• Timeline: The study involves a baseline visit and research MRI during a routine/standard of care visit. The research team will maintain contact with study participants at least annually (up to 4 years).
• Key Eligibility Criteria:
  • RRMS for 8 years or less
  • Ages 18-29
  • No relapses within 30 days of enrollment.

COAST        

• Investigator:  Enrique Alvarez, MD, PhD
• Purpose: Evaluates the safety and efficacy of ozanimod as de-escalation therapy in clinically stable MS patients previously treated with anti-CD20 therapy, transitioning from anti-Cd20 to ozanimod.
  
• Timeline: There is a screening period for up to five weeks. The core treatment period of up to 5 years includes a blood draw and MRI, plus interviews and surveys. Study participants will take remibrutinib or a placebo. There is also an extension treatment period of 3 years with remibrutinib plus study visits in the clinic.
  
• Key Eligibility Criteria:
  • RMS diagnosis and has had MS-related symptoms at least 3 years prior to baseline visit
  • Male or female participants ages 18 and older
  • No evidence of new inflammatory disease activity for at least two years prior to de-escalation
  • Has taken an anti-CD20 therapy as a DMT continuously for a minimum of two years

ENABLE                                                                 

• Investigator: Andrew Wolf, MD
• Purpose: To characterize real world experience with BRIUMVI® (ublituximab-xiiy ) treated patients.
  
• Timeline: All data is collected as part of routine patient care over 192 weeks.
  
• Key Eligibility Criteria:
  • RRMS
  • Patients who have not received any BRIUMVI® (ublituximab-xiiy) infusion prior to enrollment   

REMASTER

• Investigator: Enrique Alvarez, MD, PhD
• Purpose: A randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis.
  
• Timeline: A screening period of up to 5 weeks, followed by a core treatment period of up to approximately 5 years when participants take either remibrutinib or placebo, followed by an extension period of up to 3 years taking remibrutinib, and a safety follow-up period of 1 month.
  
• Key Eligibility Criteria:
  • SPMS diagnosis 
  • Documented evidence of disability progression in the last 12 months * SPMS diagnosis
  • EDSS 3-6