Retinal OCT biomarkers for ublituximab response in relapsing MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will use specialized optical coherence tomography (OCT) scans at enrollment and two follow-up timepoints to look for retinal imaging biomarkers of immune cell activity in people with relapsing MS. One group will start ublituximab (Briumvi) following their physician's referral while a comparison group will remain on a stable disease-modifying therapy. The study plans to enroll about 30 participants and compare imaging changes between the groups over time. Participants with ocular disease that prevents clear OCT imaging or recent B-cell depleting therapy are excluded.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Maryland, Baltimore
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Daniel Harrison, MD — University of Maryland, Baltimore
• Study coordinator: Kerry Naunton, RN
• Email: knaunton@som.umaryland.edu
• Phone: 410-328-1885

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.