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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Cetirizine; Drug: Diphenhydramine

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jeffrey Hernandez, DNP, APRN; Phone Number: 305-243-8873; Email: j.hernandez261@miami.edu

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33486
      • UHealth Boca Raton
      • Contact: Amy Barwell, RN
      • Principal Investigator: Jeffrey Hernandez, DNP, APRN
      • Sub-Investigator: Crystal Dixon, MD
      • Sub-Investigator: Melissa Ortega, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cetirizine Group; 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.	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.; Other Names: Zyrtec
Active Comparator: Diphenhydramine Group; 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.	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.; Other Names: Benadryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability as Measured by Sleepiness (Stanford Sleepiness Scale)	Sleepiness will be assessed using the Stanford Sleepiness Scale (SSS), a validated self-administered tool that rates sleepiness on a 7-point scale. Score on a 1-7 scale. Higher scores indicate greater sleepiness, and lower scores indicate greater alertness.	Baseline (pre-infusion), immediately post-infusion for Visits 1 and 2, and at 24-hour follow-up calls.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability as measured by fatigue impact Modified Fatigue Impact Scale (MFIS)	Fatigue will be assessed using the Modified Fatigue Impact Scale (MFIS), a validated 21-item self-administered questionnaire that evaluates the impact of fatigue across physical, cognitive, and psychosocial domains. Each item is scored on a 5-point Likert scale (0-4), producing a total score range of 0-84, with higher scores indicating greater fatigue impact.	Baseline (pre-infusion), immediately post-infusion for Visits 1 and 2, and at 24-hour follow-up calls.
Tolerability as measured by fatigue severity Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)	Fatigue severity will be assessed using the Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F), a validated 18-item self-administered instrument that measures the participant's current experience of fatigue and energy. Each item is scored by marking a point along a 100-mm visual analogue line anchored by "Not at all tired" (0 mm) and "Extremely tired" (100 mm). Scores are recorded as the distance in millimeters from the left anchor, producing a score range of 0-100 mm, with higher scores indicating greater fatigue severity.	Baseline (pre-infusion), immediately post-infusion for Visits 1 and 2, and at 24-hour follow-up calls.
Total Chair Time (minutes)	Total duration, in minutes, that the participant occupies the infusion chair during each study visit. Chair time will be measured from the participant's arrival for the infusion appointment to the time of discharge.	Through study completion, approximately 1 year (assessed at each infusion visit)
Number of Participants Experiencing Treatment-Related Adverse Events (AEs)	Incidence of treatment-related toxicity will be reported as the number of participants experiencing treatment-related adverse events (AEs). AEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, per physician discretion and will be identified through retrospective review of infusion documentation and follow-up assessments.	1 year
Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs)	Incidence of treatment-related toxicity will be reported as the number of participants experiencing treatment-related serious adverse events (SAEs). SAEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, per physician discretion and will be identified through retrospective review of infusion documentation and follow-up assessments.	1 year

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Jeffrey Hernandez, DNP, APRN, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amines; Benzene Derivatives; Ethylamines; Piperazines; Benzhydryl Compounds; Hydroxyzine; Diphenhydramine; Cetirizine
• Other Study ID Numbers: 20250926

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No