Real World Effectiveness, Persistence, Tolerability, and Safety of Ofatumumab in Clinical Practice (NCT06737419) | Clinical Trial Compass
CompletedNot Applicable
Real World Effectiveness, Persistence, Tolerability, and Safety of Ofatumumab in Clinical Practice
United States175 participantsStarted 2021-06-09
Plain-language summary
This was a retrospective cohort study using the electronic medical record (EMR) database from Cleveland Clinic. The data was analyzed at start of ofatumumab (OMB) therapy (baseline, defined as 6 months prior to OMB initiation) and at 6 or 12 months following initiation of OMB.
Who can participate
Age range
18 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:
* Patients who initiated OMB commercially from the time of disease modifying therapy (DMT) approval (August 2020), and
* Aged 18 years or older at index date, and
* Patients who met 2017 McDonald Criteria for clinically definite multiple sclerosis (MS), or
* Patients diagnosed with clinically isolated syndrome (CIS) by Cleveland Clinic MS specialist.
Exclusion criteria: Those who were participating in OMB clinical trials (e.g., ARTIOS, OLIKOS)
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
1
Number of Patients Categorized by Number of Relapses
Timeframe: Baseline, Month 6, Month 12
2
Change in Relapse Rate From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
Timeframe: From Baseline up to Month 6 and Month 12