NCT04287621已完成不适用
Registry of Asthma Patients Initiating DUPIXENT® (RAPID)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 718
- 试验地点
- 256
- 主要终点
- Demography
研究概览
简要总结
The primary objective of the study is to characterize the patients who initiate treatment for asthma with DUPIXENT® in a real-world setting to understand the attributes of treated patients in real life.
This includes characterization of:
- Patient demographics (eg, gender, age, and race)
- Patient baseline characteristics (eg, prior medications and procedures, medical history, asthma history, weight, height)
The secondary objectives of the study are:
- To characterize real-world use patterns of DUPIXENT® for asthma
- To assess the long-term effectiveness of DUPIXENT® in asthma patients in a real-world setting
- To assess effectiveness on comorbid type 2 inflammatory conditions in asthma patients treated with DUPIXENT®
- To collect long-term safety data on study participants in the real-world setting
详细描述
3-year registry of real-world use of DUPIXENT® for asthma in patients age 12 and over
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to comply with the required clinic visits, study procedures and assessments
- •Able to understand and complete study-related questionnaires
- •Provide signed informed consent; for patients under the age of 18, both parental (legal guardian) consent and patient assent are required
- •Initiating treatment with DUPIXENT® for a primary indication of asthma according to the country-specific prescribing information
排除标准
- •Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information
- •Treatment with dupilumab within 6 months before the screening visit, or within 6 months of the baseline visit if the screening and baseline occur on the same day
- •Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study or personal conditions and circumstances that can predictably prevent the patient from adequately completing the schedule of visits and assessments.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
结局指标
主要结局
Demography
时间窗: At Baseline
Including gender, age, race
Baseline Characteristics
时间窗: At Baseline
Including prior medications and procedures, medical history, asthma history, weight, height
次要结局
- Physician Assessment: - Spirometry(Baseline up to 3 years)
- Patient Reported Outcome: Asthma Control Questionnaire, 6-item (ACQ-6)(Baseline up to 3 Years)
- Baseline Treatment Characteristics(At Baseline)
- Incidence of adverse events (AEs)(Baseline up to 3 years)
- Physician Assessment: Fractional exhaled Nitric Oxide (FeNO)(Baseline up to 3 Years)
- Patient Reported Outcome in patients with chronic (rhino) sinusitis and/or nasal polyps: Sino-Nasal Outcome Test (SNOT-22)(Baseline up to 3 Years)
- Patient Reported Outcome: Mini Asthma Quality of Life Questionnaire (MiniAQLQ)(Baseline up to 3 Years)
- Patient Reported Outcome: Global Patient Assessment(Baseline up to 3 Years)
- Patient Reported Outcome: Physical Activity Limitation Questionnaire (PALQ)(Baseline up to 3 Years)
- Patient Reported Outcome in patients with allergic rhinitis: Allergic Rhinitis Visual Analog Scale (AR-VAS)(Baseline up to 3 Years)
- Patient Reported Outcome in patients with allergic rhinitis: Standardized Rhinoconjunctivitis Quality of Life Questionnaire for patients 12 years of age and older (RQLQ[S]+12)(Baseline up to 3 Years)
- Patient Reported Outcome: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-asthma)(Baseline up to 3 Years)
- Patient Reported Outcome in patients with atopic dermatitis: Patient Oriented Eczema Measure (POEM)(Baseline up to 3 Years)
- Healthcare Utilization: Healthcare Resource Utilization Questionnaire (HCRUQ)(Baseline up to 3 years)
研究者
研究点 (256)
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