Evaluating the safety and effectiveness of ublituximab in older adults with relapsing multiple sclerosis
A Single-Center, Prospective Cohort Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)
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 |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 55 Years to 80 Years |
| Sex | All |
| Sponsor | Neurology Center of New England P.C. Academic / other |
| Drugs / interventions | ublituximab |
| Locations | 1 site (Foxborough, Massachusetts) |
| Trial ID | NCT06681623 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Foxborough, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.