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

NCT07472413 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Jeffrey Hernandez, DNP, APRN · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-07-01
Completion
2028-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07472413 on ClinicalTrials.gov