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

ConditionMultiple Sclerosis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Cetirizine GroupExperimental treatment 1 intervention
Group B: Diphenhydramine GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Tolerability as Measured by Sleepiness (Stanford Sleepiness Scale)

Sleepiness will be assessed using the Stanford Sleepiness Scale (SSS), a validated self-administered tool that rates sleepiness on a 7-point scale. Score on a 1-7 scale. Higher scores indicate greater sleepiness, and lower scores indicate greater alertness.

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

Secondary outcomes

1

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

Fatigue will be assessed using the Modified Fatigue Impact Scale (MFIS), a validated 21-item self-administered questionnaire that evaluates the impact of fatigue across physical, cognitive, and psychosocial domains. Each item is scored on a 5-point Likert scale (0-4), producing a total score range of 0-84, with higher scores indicating greater fatigue impact.

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

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

Fatigue severity will be assessed using the Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F), a validated 18-item self-administered instrument that measures the participant's current experience of fatigue and energy. Each item is scored by marking a point along a 100-mm visual analogue line anchored by "Not at all tired" (0 mm) and "Extremely tired" (100 mm). Scores are recorded as the distance in millimeters from the left anchor, producing a score range of 0-100 mm, with higher scores indicating greater fatigue severity.

Time frame
Baseline (pre-infusion), immediately post-infusion for Visits 1 and 2, and at 24-hour follow-up calls.
3

Total Chair Time (minutes)

Total duration, in minutes, that the participant occupies the infusion chair during each study visit. Chair time will be measured from the participant's arrival for the infusion appointment to the time of discharge.

Time frame
Through study completion, approximately 1 year (assessed at each infusion visit)
4

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

Incidence of treatment-related toxicity will be reported as the number of participants experiencing treatment-related adverse events (AEs). AEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, per physician discretion and will be identified through retrospective review of infusion documentation and follow-up assessments.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: