---
title: A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)
nct_id: NCT06681623
overall_status: RECRUITING
sponsor: Neurology Center of New England P.C.
study_type: OBSERVATIONAL
primary_condition: Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06681623.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06681623"
ct_last_update_post_date: 2024-11-18
last_seen_at: "2026-05-12T06:11:58.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)

**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)

**NCT ID:** [NCT06681623](https://clinicaltrials.gov/study/NCT06681623)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Neurology Center of New England P.C.
- **Conditions:** Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
- **Start Date:** 2024-08-13
- **Completion Date:** 2027-09-30
- **CT.gov Last Update:** 2024-11-18

## 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

## Detailed Description

This study is being done to see how safe and effective ublituximab is when given to older adult patients for their RMS. Since RMS patients over age 55 were excluded from previous clinical studies that studied the safety and efficacy of ublituximab, this study is designed to better understand how well this drug is tolerated in RMS patients between the ages of 55-80 years.

Primary endpoints include:

* Incidence of infection rate from Baseline to Month 24/EOS (including UTI and other active acute, opportunistic and/or chronic infection)
* Incidence of TEAS/SAEs from Baseline to Month 24 with consideration to nature, severity, and occurrence rate of AEs

Approximately 20 participants are expected to be enrolled. Participation in this study will last approximately 24 months and will include approximately 6 study visits to the study center.

## Eligibility

- **Minimum age:** 55 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Interventions

- **Ublituximab** (DRUG) — Drug: ublituximab

## Primary Outcomes

- **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

## Secondary Outcomes

- **Total number of new and/or enlarging T2 lesions on all available brain MRI scans** _(time frame: From Baseline to Month 24/End of Study)_
- **Functional Assessment (Expanded Disability Status Scale (EDSS))** _(time frame: From Baseline to Month 24/End of Study)_
- **Multiple Sclerosis Impact Scale (MSIS-29)** _(time frame: From Baseline to Month 24/End of Study)_
- **Absolute lymphocyte count (ALC)** _(time frame: From Baseline to Month 24/End of Study)_
- **Immunoglobulin levels** _(time frame: From Baseline to Month 24/End of Study)_
- **Functional Assessment (Timed 25-Foot Walk Test (T25-FW))** _(time frame: From Baseline to Month 24/End of Study)_

## Locations (1)

- Neurology Center of New England P.C., Foxborough, Massachusetts, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.neurology center of new england p.c.|foxborough|massachusetts|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06681623.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06681623*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*