A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)

NCT06681623 | Recruiting DMC FDA Drug

• 1 other identifier: Pro00078205
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Incidence of infection (including UTI and other active acute, opportunistic and/or chronic infection)

  Incidence of infection rate from Baseline to Month 24/End of Study

  From Baseline to Month 24/End of Study

• Incidence of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs)

  Incidence of TEAEs/SAEs from Baseline to Month 24/End of Study

  From Baseline to Month 24/End of Study

Secondary Outcomes (6)

• Total number of new and/or enlarging T2 lesions on all available brain MRI scans

  From Baseline to Month 24/End of Study

• Functional Assessment (Expanded Disability Status Scale (EDSS))

  From Baseline to Month 24/End of Study

• Multiple Sclerosis Impact Scale (MSIS-29)

  From Baseline to Month 24/End of Study

• Absolute lymphocyte count (ALC)

  From Baseline to Month 24/End of Study

• Immunoglobulin levels

  From Baseline to Month 24/End of Study

Interventions

Ublituximab DRUG

Drug: ublituximab

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible subjects meeting protocol-specified criteria will be recruited from the Neurology Center of New England P.C.'s internal patient database

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurology Center of New England P.C.: lead

Study Sites (1)

Neurology Center of New England P.C.

Foxborough, Massachusetts, 02035, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ublituximab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Salvatore Napoli, MD

CONTACT

781-551-5812; ksciore@myneurodr.com

Rachel ODonnell, BS

CONTACT

781-551-5812; ResearchNCNE@myneurodr.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 8, 2024
• Study Start: August 13, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

US (1)