NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Alternate Pre-med in Anti-Cluster of Differentiation 20 (CD20) Pilot Project

Not Yet RecruitingPhase 3

Sponsor: University of Miami

Conditions: Multiple Sclerosis

Interventions: Cetirizine, Diphenhydramine

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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)

Locations (1)

Boca Raton, Florida, United States