Cetirizine vs Diphenhydramine for Multiple Sclerosis
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Jeffrey Hernandez, DNP, APRN
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of cetirizine or diphenhydramine as a pre-medication before anti-CD20 infusion therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including 24-hour follow-up calls
Long-term monitoring
Participants are monitored for treatment-related adverse events and serious adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Cetirizine
- Diphenhydramine
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants in this group will receive a single oral dose of cetirizine as a pre-medication administered 30-60 minutes before their scheduled standard-of-care anti-CD20 infusion therapy at each visit. Total participation duration is approximately 6 hours.
Participants in this group will receive a single oral dose of diphenhydramine as a pre-medication administered 30-60 minutes before their scheduled standard-of-care anti-CD20 infusion therapy at each visit. Total participation duration is approximately 6 hours.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
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