CompletedNot Applicable

Reduced Oligodendrocyte-specific Cytotoxicity and Ofatumumab Treatment

United States40 participantsStarted 2022-01-29

Plain-language summary

In this study the investigators wish to test the hypothesis that the repertoire of solutes secreted by leukocytes isolated from patients with relapsing-remitting forms of Multiple Sclerosis (MS) following 6 months of treatment with Ofatumumab (Kesimpta®) will be less toxic to mouse-derived oligodendrocyte lineage cells, grown in a dish, than solutes secreted by the same leukocyte populations prior to treatment with Ofatumumab.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: RR-MS patients only: This investigator-initiated study/trial (IIT) will be carried out secondary to the discussion of treatment with Ofatumumab and thus our study will not influence or impact the determination of the suitability for candidates to commence therapy with Ofatumumab. This decision will be made by the patient's physician as part of the patient's standard care, and will occur independently of this study. Patients to be enrolled in this longitudinal study will only be asked if they would like to take part in this IIT if their clinician independently chooses Ofatumumab as a treatment option: * Patients must qualify to receive treatment with Ofatumumab (Kesimpta), according to the Multiple Sclerosis Comprehensive Care Center at USC Keck School of Medicine or LAC+USC Medical Center and meet the inclusion criteria defined in, and aligned with, the US Kesimpta (Ofatumumab) Prescribing Information. * Patients must have clinically definite Multiple Sclerosis as defined by the revised McDonald criteria of the relapsing-remitting form with an Expanded Disability Status Scale (EDSS) score of 0 to 5.5. * Patients must be treatment naive to Ofatumumab (Kesimpta) * Patients must have the ability to understand and sign this study-specific IRB-approved informed consent form. * Patients must be willing to donate \~80ml of blood each for M00 and M06 that will be used for testing the specific aims described in this proposal. * Patients must have a lymphocyte co…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of oligodendrocyte death and mitochondrial dysfunction comparing supernatant samples from patients after 6 months treatment (M06) to pre-treatment, drug naïve supernatants (M00) and to supernatants collected from healthy control subjects

Timeframe: 27 months

Trial details

NCT IDNCT05171972

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Relapsing Remitting Multiple Sclerosis trials