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NCT Number: NCT07472413

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UHealth Boca Raton

Boca Raton, Florida, 33486, United States

Location contact

Amy Barwell, RN

CONTACT

Crystal Dixon, MD

SUB_INVESTIGATOR

Jeffrey Hernandez, DNP, APRN

PRINCIPAL_INVESTIGATOR

Melissa Ortega, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Zyrtec

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.

Other names: Benadryl

Primary outcomes

  1. Tolerability as Measured by Sleepiness (Stanford Sleepiness Scale)

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

    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.

Secondary outcomes

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

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

    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.

  2. Tolerability as measured by fatigue severity Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)

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

    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.

  3. Total Chair Time (minutes)

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

    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.

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

    Time frame: 1 year

    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.

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

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeffrey Hernandez, DNP, APRN

CONTACT

[email protected]

305-243-8873

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Cetirizine Versus Diphenhydramine as a Pre-medication: Tolerability and Safety in Patients With MS Receiving Anti-Cluster of Differentiation 20 (CD20) Infusion Therapy

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 16, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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