Cetirizine vs Diphenhydramine for Multiple Sclerosis

JH
Overseen ByJeffrey Hernandez, DNP, APRN
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Miami
Must be taking: Anti-CD20 therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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?

JH

Jeffrey Hernandez, DNP, APRN

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old or older.
I can read and speak English or Spanish.
* Able to and willing to give informed consent
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of cetirizine or diphenhydramine as a pre-medication before anti-CD20 infusion therapy

6 hours per visit
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including 24-hour follow-up calls

24 hours post-infusion
Follow-up calls

Long-term monitoring

Participants are monitored for treatment-related adverse events and serious adverse events

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Cetirizine
  • Diphenhydramine

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Cetirizine GroupExperimental Treatment1 Intervention
Group II: Diphenhydramine GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+