NCT07472413

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

Cetirizine Versus Diphenhydramine as a Pre-medication: Tolerability and Safety in Patients With MS Receiving Anti-Cluster of Differentiation 20 (CD20) Infusion Therapy

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Cetirizine	Participants will receive a single oral dose of cetirizine 10 mg administered 30-60 minutes before the scheduled standard-of-care anti-CD20 infusion at each visit.
DRUG	Diphenhydramine	Participants will receive a single oral dose of diphenhydramine 50 mg administered 30-60 minutes before the scheduled standard-of-care anti-CD20 infusion at each visit.

Timeline

• Start date: 2026-07-01
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study