NCT07472413Not yet recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 24 Feb 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- University of Miami
- Diseases
- Multiple sclerosis
- NCT number
- NCT07472413
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 60
- From 1 Nov 2026 to the primary completion date, 1 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Known hypersensitivity to cetirizine or any of its ingredients or hydroxyzine
Lab values
- Moderate or severe renal impairment (creatinine clearance or 11-31 mL/min or worse)
Age
- Patients younger than 18 years of age
Other
- Adults unable or unwilling to consent
- Pregnant women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UHealth Boca Raton Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.