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Not Yet Recruiting 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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07472413). StuddyBuddy aggregates publicly available trial information.