Alternate Pre-med in Anti-Cluster of Differentiation 20 (CD20) Pilot Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cetirizine, Diphenhydramine.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cetirizine Versus Diphenhydramine as a Pre-medication: Tolerability and Safety in Patients With MS Receiving Anti-Cluster of Differentiation 20 (CD20) Infusion Therapy
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- 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.]
Secondary outcome measures (5)
- 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.]
- 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.]
- Total Chair Time (minutes) [Time frame: Through study completion, approximately 1 year (assessed at each infusion visit)]
- Number of Participants Experiencing Treatment-Related Adverse Events (AEs) [Time frame: 1 year]
- Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs) [Time frame: 1 year]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UHealth Boca Raton — Boca Raton
Identifiers
NCT: NCT07472413 · 20250926