Comparing Risk and Severity of IRRs in Patients Premedicated With Cetirizine vs. Diphenhydramine … (NCT04175834) | Clinical Trial Compass
CompletedPhase 3
Comparing Risk and Severity of IRRs in Patients Premedicated With Cetirizine vs. Diphenhydramine Prior to Ocrelizumab
United States19 participantsStarted 2020-02-05
Plain-language summary
This 6-month randomized controlled pilot study will determine whether there is some evidence that cetirizine is better tolerated than diphenhydramine without an increase in Infusion-Related Reactions (IRRs) in subjects receiving ocrelizumab(OCR) for multiple sclerosis (MS).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female patient with relapsing or progressive forms of Multiple Sclerosis (MS), age 18 to 70 inclusive at the time of consent.
✓. Able to understand the purpose, responsibilities and risks of the study and provide signed informed consent.
✓. Naïve to ocrelizumab (OCR) and will receive OCR as part of standard of care for MS treatment.
✓. No evidence, in the opinion of the investigators of significant cognitive limitation or psychiatric disorder that would interfere with the conduct of the study.
✓. Estimated Expanded Disability Status Scale (EDSS) of ≤ 6.5 at screening.
✓. Female patients of childbearing potential must practice effective contraception and continue contraception during the study.
Exclusion criteria
✕. Any mental condition of such that patient is unable to understand the nature, scope, and possible consequences of the study.
✕. Evidence of active hepatitis B infection at screening.
✕. Patients with untreated hepatitis C, or tuberculosis. Patients who have history of Progressive multifocal leukoencephalopathy (PML) or known to be Human Immunodeficiency Virus (HIV) positive, per standard care.
✕. Any persistent or severe infection.
✕. Pregnancy or lactation.
What they're measuring
1
Proportion of Participants With Infusion-related Reaction (IRR) on Day 0
Timeframe: During or after the first-half dose of the first infusion on day 0