Evaluating the safety and effectiveness of ublituximab in older adults with relapsing multiple sclerosis
Official title: A Single-Center, Prospective Cohort Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)
Run by Neurology Center of New England P.C. · NCT06681623 · Data updated 2026-11-12
This study is testing whether a new medication called ublituximab is safe and effective for older adults aged 55 to 80 with relapsing multiple sclerosis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 55 Years to 80 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Neurology Center of New England P.C. Academic / other |
| Drugs / interventions | ublituximab |
| Locations | 1 site (Foxborough, Massachusetts) |
| Status | Recruiting |
| Started | August 13, 2024 |
| Main results expected | September 30, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | November 18, 2024 |
| Trial ID | NCT06681623 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are older adults aged 55-80 who have been diagnosed with relapsing forms of multiple sclerosis and are either starting or have recently begun treatment with ublituximab.
✕Probably not a fit
Patients who are actively participating in another interventional clinical trial for MS or have a history of severe infusion reactions to anti-CD20 therapies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the safety and efficacy of ublituximab in older adults diagnosed with relapsing forms of multiple sclerosis (RMS). It specifically focuses on patients aged 55 to 80 years, a demographic that was excluded from previous trials. The study will monitor the incidence of infections and other adverse events over a 24-month period, with approximately 20 participants expected to enroll. Participants will attend around six study visits at the Neurology Center of New England in Foxboro, Massachusetts.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety of ublituximab for older adults with RMS, potentially leading to improved treatment options for this age group.
How similar studies have gone: While this study focuses on an older population that has been previously excluded, similar studies on ublituximab have shown promising results in younger populations, indicating potential for success in this novel demographic.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Neurology Center of New England P.C.
Foxborough, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Salvatore Napoli, MD
- Email: ksciore@myneurodr.com
- Phone: 781-551-5812
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study tests whether ublituximab can help reduce symptoms in adults with treatment‑resistant schizophrenia who are already taking standard antipsychotic therapy.
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This study tests whether giving ublituximab as maintenance after a positive response to efgartigimod helps adults with myasthenia gravis.
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Ublituximab in MS: how injection site and delivery method affect absorption
This study tests how different SC injection sites and a prefilled pen delivery compare in how ublituximab behaves in the body for people with relapsing MS.
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Switching to ublituximab for ocrelizumab wearing-off in multiple sclerosis
This pilot will try switching people with relapsing MS who experience symptom 'wearing off' on ocrelizumab to ublituximab to see if their symptoms improve or return later.
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Ublituximab (Briumvi) for early relapsing MS
This study will test whether giving Ublituximab (Briumvi) about twice a year is safe and changes a blood marker (neurofilament light) in adults with early relapsing MS.
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This study tests whether ublituximab can work in children and teens with relapsing MS and compares it to fingolimod in eligible participants.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.