Recruiting

Ublituximab

Sponsor:

Neurology Center of New England P.C.

Code:

NCT06681623

Conditions

Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Ublituximab

Study Details

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

Study ID

NCT06681623

Start date

Aug 13, 2024

Status verified date

Nov, 2024

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Interventions

Ublituximab

Drug: ublituximab

Primary outcome measure

  • 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 treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) [ Time Frame: From Baseline to Month 24/End of Study ]

Central Contacts and Locations

Central contacts

Salvatore Napoli, MD

781-551-5812ksciore@myneurodr.com

Rachel ODonnell, BS

781-551-5812ResearchNCNE@myneurodr.com

Locations

Neurology Center of New England P.C.

Recruiting

Foxboro, Massachusetts, United States, 02035

Contacts

Rachel ODonnell

781-551-5812ResearchNCNE@myneurodr.com

Jillian Pellegrini

781-551-5812ResearchNCNE@myneurodr.com

Principal Investigator:

Salvatore Napoli, MD

More Information

Sponsor

Neurology Center of New England P.C.

Last update posted

Nov 18, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Neurology Center of New England P.C. on 2024-11-18.