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 States111 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 range18 Years – 60 Years
SexALL
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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:
✕. Discontinuing aCD20 mAb therapy due to the following treatment- emergent adverse events:
✕. Severe infusion-related reactions (Grade 3 or above)
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
. 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).