Cetirizine Versus Diphenhydramine as a Pre-medication: Tolerability and Safety in Patients With MS Receiving Anti-Cluster of Differentiation 20 (CD20) Infusion Therapy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tolerability as Measured by Sleepiness (Stanford Sleepiness Scale)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Diphenhydramine (Drug)
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.
干预措施: Cetirizine (Drug)
结局指标
主要结局
Tolerability as Measured by Sleepiness (Stanford Sleepiness Scale)
时间窗: Baseline (pre-infusion), immediately post-infusion for Visits 1 and 2, and at 24-hour follow-up calls.
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.
次要结局
- Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs)(1 year)
- 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.)
- 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.)
- 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)
研究者
Jeffrey Hernandez
Supervisor, Advanced Practice Providers
University of Miami