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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Infusions
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares cetirizine and diphenhydramine given before certain multiple sclerosis (MS) medicines through an IV. It tests how well patients tolerate these drugs and how safely they prevent reactions to the IV treatment. It is for adults with MS who are starting or already receiving ocrelizumab, ublituximab, or rituximab.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Are age 18 or older.
- Can read and speak English or Spanish.
- Can and are willing to give informed consent, meaning you understand and agree to join the study.
- Have multiple sclerosis (MS).
- Are starting or already receiving ocrelizumab, ublituximab, or rituximab.
Who can't join
- Cannot or do not want to give informed consent.
- Are younger than 18.
- Are pregnant.
- Have a known allergy to cetirizine, any of its ingredients, or hydroxyzine.
- Have moderate or severe kidney problems.
- Have had allergic reactions to treatment and take extra medicines to prevent another reaction, such as allergy or stomach-acid medicines the night before an IV treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official 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)
Study sites (1)
FL
- UHealth Boca Raton · Boca Raton, FL 33486Amy Barwell, RN · Study contactJeffrey Hernandez, DNP, APRN · Principal investigatorCrystal Dixon, MD · Sub-investigatorMelissa Ortega, MD · Sub-investigatorMore trials in Boca Raton