A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients Wit… (NCT04486716) | Clinical Trial Compass
CompletedPhase 3
A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis
United States, Puerto Rico111 participantsStarted 2020-10-19
Plain-language summary
A single arm study evaluating the continued efficacy, safety and tolerability of ofatumumab in patients with relapsing multiple sclerosis who are transitioning from aCD20 mAb therapy
Who can participate
Age range
18 Years – 60 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
. Written informed consent must be obtained before any assessment is performed.
. Male or female participants aged 18 to 60 years (inclusive) at screening.
. Diagnosis of relapsing MS (RMS) according to the 2017 Revised McDonald criteria (Thompson et al. 2018), including CIS, RRMS or SPMS with disease activity as defined by (Lublin et al. 2014).
. Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive).
. Received at least 2 courses of intravenous aCD20 mAb (loading doses are considered 1 course):
. At least 2 fully infused courses of rituximab 500 mg - 1000 mg iv every 6 months (+/- one month).
. Initial loading regimens of rituximab i.e. 500 mg - 1000 mg on day 1 and on day 15, are allowed but this is consider a single course and must be followed by additional infusion(s) every 6 months (+/- one month)
. Last fully infused rituximab dose must have occurred within 4-9 months prior to baseline.
Exclusion criteria
. Participants that have demonstrated suboptimal response to aCD20 therapy to include:
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
Percentage of Participants With no Change or a Reduction From Baseline in the Number of Gadolinium Enhancing (GdE) Lesions at Month 12 Using Non-responder Imputation
Timeframe: Baseline (assessed at screening visit), Month 12
2
Percentage of Participants With no Change or a Reduction From Baseline in the Number of Gadolinium Enhancing (GdE) Lesions at Month 12 Based on Observed Data
Timeframe: Baseline (assessed at screening visit), Month 12
. Discontinuing aCD20 mAb therapy due to the following treatment- emergent adverse events:
. Severe infusion-related reactions (Grade 3 or above)
. Recurrent infections defined as ≥ 2 severe infections or ≥ 3 respiratory infections or the need for ≥ 2 courses of antibiotics since starting aCD20 therapy, if the Investigator believes this is related to therapy.
. Decreased IgG requiring treatment with Intravenous immunoglobulin
. Participants with primary progressive MS (Polman et al 2011) or SPMS without disease activity (Lublin et al 2014).
. Participants meeting criteria for neuromyelitis optica (Wingerchuk et al 2015).