Multiple Sclerosis, Relapsing Forms of Multiple SclerosisNCT06681623
A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)
An observational study of Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis, run by Neurology Center of New England P.C. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
- What is being tested?
- Ublituximab
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2024to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible subjects meeting protocol-specified criteria will be recruited from the Neurology Center of New England P.C.'s internal patient database
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Neurology Center of New England P.C.
Foxborough, Massachusetts, 02035
Rachel ODonnell, 781-551-5812 ext. x2, ResearchNCNE@myneurodr.com
Jillian Pellegrini, 781-551-5812 ext. x2, ResearchNCNE@myneurodr.com
About this study
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)
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
Read the 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.
- Being tested
- Ublituximab
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UblituximabDrug
Drug: ublituximab
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Change from Baseline to Month 24/End of Study in total number of new and/or enlarging T2 lesions on all available brain MRI scans
Measured: From Baseline to Month 24/End of Study
Functional Assessment (Expanded Disability Status Scale (EDSS))
Change from Baseline to Month 24/End of Study in EDSS
Measured: From Baseline to Month 24/End of Study
Multiple Sclerosis Impact Scale (MSIS-29)
Change from Baseline to Month 24/End of Study in Multiple Sclerosis Impact Scale (MSIS-29)
Measured: From Baseline to Month 24/End of Study
Absolute lymphocyte count (ALC)
Change from Baseline to Month 24/End of Study in ALC
Measured: From Baseline to Month 24/End of Study
Immunoglobulin levels
Change from Baseline to Month 24/End of Study in immunoglobulin levels
Measured: From Baseline to Month 24/End of Study
Functional Assessment (Timed 25-Foot Walk Test (T25-FW))
Change from Baseline to Month 24/End of Study in T25-FW
Measured: From Baseline to Month 24/End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start13 Aug 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing Forms of Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurology Center of New England P.C.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681623
- Sponsor's protocol ID
- Pro00078205
- Status last verified
- Nov 2024
- First submitted
- 28 Oct 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06681623
- Acronym / sponsor ID
- Pro00078205
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Neurology Center of New England P.C.University, hospital or other
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible subjects meeting protocol-specified criteria will be recruited from the Neurology Center of New England P.C.'s internal patient database
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UblituximabDrug: ublituximab | Drug | – |
Primary outcome
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
6 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis, run by Neurology Center of New England P.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salvatore Napoli, MD (781-551-5812, ksciore@myneurodr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024; AzTrials last refreshed its copy on 1 Nov 2026.