Ocrelizumab for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolate… (NCT04877457) | Clinical Trial Compass
TerminatedPhase 4
Ocrelizumab for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease.
Stopped: Slow enrollment
United States3 participantsStarted 2022-02-15
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled, Phase 4 study in which eligible patients with RADIOLOGICALLY ISOLATED SYNDROME (RIS) (as defined by meeting 2017 McDonald criteria for DIS) will be randomized 1:1 to receive ocrelizumab treatment or placebo (standard of care).
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria
Pre-Screening of First-Degree Family Members
Family members must meet the following inclusion criteria for pre-screening:
Signed informed consent form First-degree family member of an individual with clinically definite MS Age 18-55 years No prior exposure to DMT or long-term immunomodulatory medications Willingness to participate in full study protocol, if RIS is discovered
Screening
Patients must meet the following inclusion criteria for screening:
Signed informed consent form
One of the following:
First degree family member of an individual with clinically definite MS who was identified to have CNS lesions meeting McDonald 2017 criteria for DIS during a pre-screening MRI.
Established RIS diagnosis (i.e. CNS lesions consistent with MS, meeting McDonald 2017 criteria for DIS), either diagnosed within the last 5 years or known to have had accumulation of CNS lesions within the last 5 years.
Age 18-55 years No prior exposure to DMT or long-term immunomodulatory medications Willingness to participate in full study protocol
Randomization
Patients must meet the following criteria for study entry and randomization:
Signed Informed Consent Form Aged 18-55 years at time of signing Informed Consent Form Ability to provide written informed consent and be compliant with the study protocol CNS lesions consistent with MS, meeting McDonald 2017 criteria for DIS RIS diagnosis established within last 5 years OR with known accumulation of CNS lesions within la…
What they're measuring
1
Time to Development of First New Radiologic or Clinical Evidence of MS