A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With… (NCT06681623) | Clinical Trial Compass
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.
1This trial is specifically studying ublituximab in older adults with relapsing MS — does my age and overall health profile make me a reasonable candidate to discuss for this study, and what would that conversation look like with my care team?
2The trial's main focus is tracking infections, including UTIs and opportunistic infections — given my personal health history, how concerned should I be about infection risk with ublituximab, and how would that risk be monitored if I were to participate?
3Since this is listed as Phase NA and appears to be a characterization study rather than a traditional efficacy trial, does that mean there's less known about how well ublituximab works specifically in older adults, and how does that uncertainty compare to MS treatments I might already be eligible for?
4The study is measuring treatment-emergent serious adverse events — what kinds of serious adverse events have been reported with ublituximab in previous studies, and are older adults generally at higher risk for those compared to younger patients?
5Before considering a trial like this, would it make more sense to try an established disease-modifying therapy first, or is there a reason my doctor might think participating in this study could be worth exploring as part of my care plan?
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
1
Incidence of infection (including UTI and other active acute, opportunistic and/or chronic infection)
Timeframe: From Baseline to Month 24/End of Study
2
Incidence of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs)