NCT06681623 · Neurology Center of New England P.C.
A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)
What this study is about
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
View original scientific description
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
Interventions
DRUG
Ublituximab
Drug: ublituximab
Primary outcome measures
Incidence of infection (including UTI and other active acute, opportunistic and/or chronic infection)
Time frame: From Baseline to Month 24/End of Study
Incidence of infection rate from Baseline to Month 24/End of Study
Incidence of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs)
Time frame: From Baseline to Month 24/End of Study
Incidence of TEAEs/SAEs from Baseline to Month 24/End of Study
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Foxborough, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 18, 2024 · Source of record for eligibility and locations