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

Part of paid clinical trials in Boca Raton, Florida.

Sponsor
University of Miami
Study ID
NCT07472413
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Feb 2026
Primary completion
Jul 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cetirizine Group
    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.
  • Active Comparator: Diphenhydramine Group
    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.

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UHealth Boca RatonBoca RatonFlorida33486
Amy Barwell, RN
Jeffrey Hernandez, DNP, APRN (PRINCIPAL_INVESTIGATOR)
Crystal Dixon, MD (SUB_INVESTIGATOR)
Melissa Ortega, MD (SUB_INVESTIGATOR)

Find similar trials in Boca Raton, FL

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
UHealth Boca Raton· Boca Raton, FL

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