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NCT07472413
Alternate Pre-med in Anti-Cluster of Differentiation 20 (CD20) Pilot Project
Conditions: Multiple Sclerosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 60
Sponsor: University of Miami
Location: UHealth Boca Raton Boca Raton Florida
Summary
The purpose of this study is to assess and compare how well multiple sclerosis (MS) patients tolerate cetirizine versus diphenhydramine as a pre-medication before receiving anti-CD20 infusion therapy of ocrelizumab, ublituximab or rituximab. The study will also compare the safety of cetirizine versus diphenhydramine as a pre-medication for preventing infusion reactions in MS patients receiving anti-CD20 infusion therapy.
Eligibility Criteria
Inclusion Criteria:
* Ages ≥18 years
* Able to read and speak in English or Spanish
* Able to and willing to give informed consent
* Diagnosis of Multiple Sclerosis (MS)
* Patients starting or currently receiving ocrelizumab, ublituximab, rituximab
Exclusion Criteria:
* Adults unable or unwilling to consent
* Patients younger than 18 years of age
* Pregnant women
* Known hypersensitivity to cetirizine or any of its ingredients or hydroxyzine
* Moderate or severe renal impairment (creatinine clearance or 11-31 mL/min or worse)
* Patients with prior hypersensitivity reactions on additional preventative measures (e.g. H1 and H2/proton-pump inhibitor (PPI) the night prior to the infusion due to history of reactions)
Source: ClinicalTrials.gov (NCT07472413). StuddyBuddy aggregates publicly available trial information.