BridgeMD
New treatment option for Multiple Sclerosis (MS) - Relapsing-remitting
Official title Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis
ClinicalTrials.gov ID: NCT06864936
What this study is testing
What is Ublituximab?
Ublituximab is an investigational medicine, being studied as a potential treatment for multiple sclerosis (ms) - relapsing-remitting.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- For Ublituximab Group:
- Ages 18-65
- A diagnosis of relapsing MS (to include relapsing-remitting MS and active secondary progressive MS) according to 2017 Revised McDonald Criteria.
- A recent referral for initiation of ublituximab for treatment of MS by the patient's treating physician. For Comparison Group:
- Ages 18 - 65
You likely can't join if
- For Ublituximab Group:
- Known eye disease that may, in the opinion of the screening ophthalmologist, preclude proper analysis of data in this study. This includes, but is...
- Treatment with any B-cell depleting disease modifying therapy for MS (i.e. rituximab, ocrelizumab, ofatumumab, ublituximab, etc.) within the past 12...
- History of life-threatening infusion reaction on ublituximab or prior anti-CD20 therapy
- Any chronic or active infection that would preclude anti-CD20 therapy. This may include but is not limited to active hepatitis B virus (HBV)...
- Receipt of any live of live-attenuated vaccines within 4 weeks prior to first ublituximab administration For Comparison Group:
See the full eligibility criteria
- For Ublituximab Group:
- Ages 18-65
- A diagnosis of relapsing MS (to include relapsing-remitting MS and active secondary progressive MS) according to 2017 Revised McDonald Criteria.
- A recent referral for initiation of ublituximab for treatment of MS by the patient's treating physician. For Comparison Group:
- Ages 18 - 65
- A diagnosis of relapsing-remitting MS according to 2017 Revised McDonald Criteria.
- Currently on a stable dose of disease modifying treatment for MS with no plans for alternative therapy for the following year.
- For Ublituximab Group:
- 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.
- Treatment with any B-cell depleting disease modifying therapy for MS (i.e. rituximab, ocrelizumab, ofatumumab, ublituximab, etc.) within the past 12 months.
- History of life-threatening infusion reaction on ublituximab or prior anti-CD20 therapy
- 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...
- Receipt of any live of live-attenuated vaccines within 4 weeks prior to first ublituximab administration For Comparison Group:
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.