Comparing the Risk and Severity of Infusion-Related Reactions in Patients Premedicated With Cetirizine Versus Diphenhydramine Prior to Ocrelizumab Infusions
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Infusion-related Reaction (IRR) on Day 0
研究概览
简要总结
This 6-month randomized controlled pilot study will determine whether there is some evidence that cetirizine is better tolerated than diphenhydramine without an increase in Infusion-Related Reactions (IRRs) in subjects receiving ocrelizumab(OCR) for multiple sclerosis (MS).
详细描述
Ocrelizumab was approved by the US Food and Drug administration in March 2017 for the indication of Relapsing Remitting Multiple Sclerosis (RRMS) and Primary Progressive Multiple Sclerosis (PPMS). The landmark studies used to gain approval found ocrelizumab (OCR) to be well tolerated, but that at least one Infusion-Related Reaction (IRR) occurred in about one-third of patients. Because of this, neurologists typically prescribe prophylactic premedication with 100mg of methylprednisolone, 1 gram of acetaminophen, and 50 mg of IV diphenhydramine. However, many patients experience extreme sedation that interferes with their lifestyle considerably.
This 6-month randomized controlled pilot study will determine whether there is some evidence that cetirizine is better tolerated than diphenhydramine without an increase in IRRs. Fifty-two patients, 26 patients per arm, will be randomized in a 1:1 ratio to receive cetirizine or diphenhydramine as premedication prior to OCR infusions on day 0 (1st half dose of 300mg), day 14 (2nd half dose of 300mg) and week 24 (1st full dose of 600mg).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient with relapsing or progressive forms of Multiple Sclerosis (MS), age 18 to 70 inclusive at the time of consent.
- •Able to understand the purpose, responsibilities and risks of the study and provide signed informed consent.
- •Naïve to ocrelizumab (OCR) and will receive OCR as part of standard of care for MS treatment.
- •No evidence, in the opinion of the investigators of significant cognitive limitation or psychiatric disorder that would interfere with the conduct of the study.
- •Estimated Expanded Disability Status Scale (EDSS) of ≤ 6.5 at screening.
- •Female patients of childbearing potential must practice effective contraception and continue contraception during the study.
排除标准
- •Any mental condition of such that patient is unable to understand the nature, scope, and possible consequences of the study.
- •Evidence of active hepatitis B infection at screening.
- •Patients with untreated hepatitis C, or tuberculosis. Patients who have history of Progressive multifocal leukoencephalopathy (PML) or known to be Human Immunodeficiency Virus (HIV) positive, per standard care.
- •Any persistent or severe infection.
- •Pregnancy or lactation.
- •Significant, uncontrolled somatic disease or severe depression in the last year.
- •Current use of immunosuppressive medication, lymphocyte-depleting agents, or lymphocyte-trafficking blockers.
- •Patients with any significant comorbidity that in the opinion of the investigator, would interfere with participation in the study.
- •Any known allergy or inability to tolerate diphenhydramine or cetirizine.
研究组 & 干预措施
diphenhydramine
25 mg diphenhydramine capsule, generic, sourced from Major Pharmaceuticals will be give orally 30-60 minutes prior to ocrelizumab infusion.
干预措施: diphenhydramine (Drug)
cetirizine
10 mg cetirizine tablet, generic, sourced from Mylan Pharmaceuticals will be give orally 30-60 minutes prior to ocrelizumab infusion.
干预措施: cetrizine (Drug)
结局指标
主要结局
Proportion of Participants With Infusion-related Reaction (IRR) on Day 0
时间窗: During or after the first-half dose of the first infusion on day 0
The proportion of patients having an infusion-related reaction (IRR), as defined by Common Terminology Criteria (CTCAE), version 4 during or after the first-half dose of the first infusion on day 0. IRRs are documented at the infusion clinic on the day of infusion and reported by the patient at the follow-up phone call the next business day after the infusion.
次要结局
- Proportion of Participants With Infusion-related Reaction (IRR) on Day 14(during or after receiving the second half dose infusion on day 14.)
- Proportion of Participants With an Infusion-related Reaction (IRR) on Day 168(during or after receiving the first full 600mg dose infusion on day 168.)
- Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168(After the infusions on day 0, day 14, and day 168.)
- Stanford Sleepiness Scale (SSS) Score on Days 0, 14, and 168(after the infusions on day 0, day 14, and day 168.)
- Visual Analog Scale for Fatigue (VAS-F) Score on Days 0, 14 and 168(after the infusions on day 0, day 14, and day 168.)
- Modified Fatigue Impact Scale (MFIS) Score on Day 168(at day 168.)
- Multiple Sclerosis Impact Scale (MSIS-29) Score on Day168(at day 168.)