RecruitingNot Applicable

A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)

United States20 participantsStarted 2024-08-13

Plain-language summary

The purpose of this study is to evaluate the safety of ublituximab use in the older MS adult population, as measured by incidence of infection rate

Who can participate

Age range

55 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed informed consent * Aged 55-80 years old * Diagnosis of RMS according to the 2017 Revised McDonald criteria * Anticipated to begin treatment with or newly treated with ublituximab (within 6 months prior to study entry) according to the local label Exclusion Criteria: * Active participation in an interventional clinical trial for MS * Received initial dose of ublituximab more than 6 months prior to study entry * History of life-threatening infusion reaction on any anti-CD20 therapy * Evidence of clinically significant chronic or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment, or any history of recurrent infection within 6-12 months prior to initiation of ublituximab

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of infection (including UTI and other active acute, opportunistic and/or chronic infection)

Timeframe: From Baseline to Month 24/End of Study

Incidence of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs)

Timeframe: From Baseline to Month 24/End of Study

Trial details

NCT IDNCT06681623

SponsorNeurology Center of New England P.C.

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-09-30

Contact for this trial

Salvatore Napoli, MD

781-551-5812 ksciore@myneurodr.com

View on ClinicalTrials.gov More Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis trials

Who can participate

Age range

55 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.