RELIEF: Remibrutinib in Chronic Spontaneous Urticaria: Early Real World Effectiveness and Satisfaction Survey
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Change From Baseline in Urticaria Control Test - 7 Day Recall (UCT-7) Score at Week 4 in Patients Initiating Remibrutinib
研究概览
简要总结
This is a United States (US) based, prospective, non-interventional, provider-referral study to evaluate the real-world effectiveness and patient-centered outcomes of remibrutinib in chronic spontaneous urticaria (CSU) patients using validated patient reported outcome (PRO) tools.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthcare provider (HCP) participants eligible to refer patients for inclusion in this study must meet all the following criteria:
- •Have an active medical license and be board certified/board eligible allergist or dermatologist in the US. Nurse practitioners and physician assistant practicing in allergy and dermatology are eligible.
- •Manage CSU patients within their practice.
- •Enrolled in the research network or are referred HCPs who agree to participate.
- •Have the requisite patient population based on study inclusion/
排除标准
- •Patients eligible for inclusion in this study must meet all of the following criteria:
- •≥ 18 years of age.
- •Diagnosed with CSU by an HCP.
- •Have received a prescription for remibrutinib or dupilumab and are expected to initiate treatment.
- •Have access to an electronic device with internet capabilities.
- •Able to read and understand English.
- •Willing and able to provide consent for study participation.
- •Exclusion criteria:
- •Patients will be excluded if they meet any of the following criteria:
- •Unable to procure remibrutinib or dupilumab (through samples, commercially or patient assistance program).
- •Exposure to oral corticosteroid treatment in 14 days prior to consent.
- •Exposure to oral corticosteroid treatment in 14 days prior to initiating treatment with remibrutinib or dupilumab.
- •Prior participation in a remibrutinib or dupilumab clinical trial.
- •Cognitive impairment that impacts the patient's ability to participate.
研究组 & 干预措施
Remibrutinib Cohort
Adult patients with CSU who are prescribed and initiating treatment with remibrutinib.
Dupilumab Cohort
Adult patients with CSU who are prescribed and initiating treatment with dupilumab.
结局指标
主要结局
Change From Baseline in Urticaria Control Test - 7 Day Recall (UCT-7) Score at Week 4 in Patients Initiating Remibrutinib
时间窗: Baseline and Week 4
UCT-7 is a validated PRO tool designed to assess disease control over a 7-day recall period. It evaluates symptom burden, quality of life impact, treatment adequacy, and overall disease control. It consists of 4 questions, each of which is scored 0-4, with a total score range of 0-16. A score of \<12 indicates poor disease control, 12-15 = partial control, and 16 indicates complete control.
次要结局
- Change From Baseline in UCT-7 Score at Week 1 in Patients Initiating Remibrutinib(Baseline and Week 1)
- Proportion of Patients With a UCT-7 Score ≥12 at Week 1 and Week 4 in Patients Initiating Remibrutinib(Week 1 and Week 4)
- Treatment Satisfaction Questionnaire for Medication - Version 9 (TSQM-9) Domain Scores at Week 4 in Patients Initiating Remibrutinib(Week 4)
- Change From Baseline in TSQM-9 Domain Scores at Week 4 in Patients Initiating Remibrutinib(Baseline and Week 4)
- Treatment Satisfaction Assessed by TSQM-9 Overall Score at Week 4 in Patients Initiating Remibrutinib(Week 4)
- Change From Baseline in TSQM-9 Overall Score at Week 4 in Patients Initiating Remibrutinib(Baseline and Week 4)