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Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether special eye scans called OCT can show changes in immune cell activity in MS during treatment with ublituximab (Briumvi). It is for adults with relapsing MS who are about to start Briumvi, and adults with stable relapsing-remitting MS who will stay on their current treatment. Eye scans are done at the start and two more times during the study.

The purpose of the research study is to explore new retinal imaging biomarkers of immune cell activity in MS during use of ublituximab (Briumvi) treatment. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. This study will evaluate the efficacy of ublituximab to modulate MS pathology in a new manner. In order to assess this new biomarker, a specialized optical coherence tomography (OCT) scan will be performed at enrollment into the study and at 2 other timepoints throughout the study. Subjects asked to take part in this study should have been diagnosed with relapsing multiple sclerosis (MS) and have recently been advised to start the medication ublituximab (Briumvi) or are currently on another medication for the treatment of their MS. We plan to enroll 30 patients into this study. Fifteen (15) patients with Relapsing Remitting Multiple Sclerosis (RRMS) who are being initiated on B-cell depletion therapy by their treating physician at the University of Maryland Center for MS Treatment and Research will be offered enrollment into this study. Additionally, 15 age/sex matched patients with stable RRMS who are not undergoing any change in treatment and are not currently on B-cell depleting therapies will be enrolled as control subjects.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: Ages 18–65.
  • Briumvi group: Have relapsing MS, including relapsing-remitting MS or active secondary progressive MS, diagnosed using the study's required medical standards.
  • Briumvi group: Your MS doctor recently referred you to start Briumvi.
  • Comparison group: Have relapsing-remitting MS, which causes flare-ups followed by periods of recovery, diagnosed using the study's required medical standards.
  • Comparison group: Take a stable dose of an MS treatment, with no plans to switch treatments for the next year.

Who can't join

  • Both groups: Have an eye disease that the eye doctor believes could make the scan results hard to assess. Examples include eye damage from diabetes, macular degeneration, and glaucoma.
  • Both groups: Used an MS drug that removes B cells, a type of immune cell, in the past 12 months. Examples include rituximab, ocrelizumab, ofatumumab, and ublituximab.
  • Briumvi group: Have had a life-threatening reaction to an infusion of Briumvi or another anti-CD20 drug, a type of treatment that removes B cells.
  • Briumvi group: Have a long-term or active infection that makes anti-CD20 treatment unsafe. Examples may include active hepatitis B, tuberculosis, or HIV.
  • Briumvi group: Received a vaccine containing live or weakened germs within 4 weeks before the first Briumvi dose.
  • Comparison group: Plan to start a treatment that removes B cells in the next year.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: For Ublituximab Group: 1. Ages 18-65 2. A diagnosis of relapsing MS (to include relapsing-remitting MS and active secondary progressive MS) according to 2017 Revised McDonald Criteria. 3. A recent referral for initiation of ublituximab for treatment of MS by the patient's treating physician. For Comparison Group: 1. Ages 18 - 65 2. A diagnosis of relapsing-remitting MS according to 2017 Revised McDonald Criteria. 3. Currently on a stable dose of disease modifying treatment for MS with no plans for alternative therapy for the following year. Exclusion Criteria: For Ublituximab Group: 1. Known eye disease that may, in the opinion of the screening ophthalmologist, preclude proper analysis of data in this study. This includes, but is not limited to diabetic retinopathy, macular degeneration, and glaucoma. 2. Treatment with any B-cell depleting disease modifying therapy for MS (i.e. rituximab, ocrelizumab, ofatumumab, ublituximab, etc.) within the past 12 months. 3. History of life-threatening infusion reaction on ublituximab or prior anti-CD20 therapy 4. Any chronic or active infection that would preclude anti-CD20 therapy. This may include but is not limited to active hepatitis B virus (HBV) confirmed by positive results for Hepatitis B surface antigen (HBsAg) and anti-HBV tests, tuberculosis, and human immunodeficiency virus (HIV). 5. Receipt of any live of live-attenuated vaccines within 4 weeks prior to first ublituximab administration For Comparison Group: 1. Known eye disease that may, in the opinion of the screening ophthalmologist, preclude proper analysis of data in this study. This includes, but is not limited to diabetic retinopathy, macular degeneration, and glaucoma. 2. Treatment with any B-cell depleting disease modifying therapy (i.e. rituximab, ocrelizumab, ofatumumab, ublituximab, etc.) within the past 12 months, or plans to initiate such a therapy in the following year.

Study sites (1)

MD