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

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

Not yet recruitingPhase 3MS (type not specified)NCT07472413

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Cetirizine

Compared with

  • Diphenhydramine

What it measured

Main measures

  • Tolerability as Measured by Sleepiness (Stanford Sleepiness Scale)

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

    Mood and sleepSafety

Other measures (5)

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

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

    Thinking and memoryFatigueSafety

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

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

    FatigueSafety

  • Total Chair Time (minutes)

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

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

    1 year

    Safety

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

    1 year

    Safety

Who could take part

MS (type not specified) · 18 and over

Show the full 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)

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's 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.

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History

    1. Started

      Nov 2026

    2. Main results due

      Jul 2028

    3. Finished

      Jul 2028

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