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

NCT07472413 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 20250926
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Tolerability as measured by fatigue impact Modified Fatigue Impact Scale (MFIS)

  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)

  Baseline (pre-infusion), immediately post-infusion for Visits 1 and 2, and at 24-hour follow-up calls.

• Total Chair Time (minutes)

  Through study completion, approximately 1 year (assessed at each infusion visit)

• Number of Participants Experiencing Treatment-Related Adverse Events (AEs)

  1 year

• Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs)

  1 year

Study Arms (2)

Cetirizine Group

EXPERIMENTAL

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

Diphenhydramine Group

ACTIVE COMPARATOR

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

Interventions

Cetirizine DRUG

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.

Also known as: Zyrtec

Cetirizine Group

Diphenhydramine DRUG

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.

Also known as: Benadryl

Diphenhydramine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

UHealth Boca Raton

Boca Raton, Florida, 33486, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cetirizine; Diphenhydramine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jeffrey Hernandez, DNP, APRN

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Hernandez, DNP, APRN

CONTACT

305-243-8873; j.hernandez261@miami.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor, Advanced Practice Providers

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 16, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)