A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)
A Single-Center, Prospective Cohort Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 55 Years to 80 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
- Visits mentioned: 6 visits
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participation in this study will last approximately 24 months and will include approximately 6 study visits to the study center."
- 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
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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
Study sites (1)
MA
- Neurology Center of New England P.C. · Foxborough, MA 02035Rachel ODonnell · Study contact · 781-551-5812 ext. x2 · ResearchNCNE@myneurodr.comJillian Pellegrini · Study contact · 781-551-5812 ext. x2 · ResearchNCNE@myneurodr.comSalvatore Napoli, MD · Principal investigatorMore trials in Foxborough