NCT05689151招募中不适用
Treating Atopic Dermatitis With Abrocitinib and Its Impact in Real Life: An Observational Cohort Study To Describe the Effectiveness of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 183
- 试验地点
- 56
- 主要终点
- Proportion of patients with an Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5- point scale) and a reduction from baseline of ≥2 points
研究概览
简要总结
The purpose of this study is to learn about the safety and effects of Abrocitinib in the real-life clinical setting given for the treatment of moderate to severe atopic dermatitis. Atopic dermatitis, or AD, is a long-lasting disease that causes inflammation, redness, and irritation of the skin.
This study is seeking participant who are older than 18 years with moderate-to-severe chronic AD. Participants must have no underlying medical conditions that prevent them from taking Abrocitinib.
All participants in this study will receive Abrocitinib as a tablet once daily. They can take Abrocitinib and use medicated topical treatment for AD at the same time.
We will examine the experiences of patients receiving the study medicine. This will help us determine if the study medicine is safe and helps in treating AD.
Participants will take part in this study for 24 months. During this time, they will visit the study clinic about 5 times (about 1 time every 4 to 6 months).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years of age at inclusion.
- •Patients with clinical diagnosis of moderate-to-severe chronic atopic dermatitis (also referred to as atopic eczema) at inclusion according to the investigator and eligible for abrocitinib according to its marketing approval.
- •Patients that have been informed of the study procedures and have signed the consent.
排除标准
- •Patients for whom abrocitinib is contraindicated.
- •Patients unable to follow and respect the study procedures and judged inapt to respond to the questions required for the study due to linguistical, psychological, social, or geographical reasons.
- •Patients not affiliated to the French social security system.
- •Patients deprived of liberty, under guardianship, or unable to provide oral consent.
- •Patients participating in a clinical study assessing a medicinal treatment (patients can participate in registries and observatories).
结局指标
主要结局
Proportion of patients with an Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5- point scale) and a reduction from baseline of ≥2 points
时间窗: 16 weeks
次要结局
- Disease Characteristics of Participants: IGA score(Baseline)
- Proportion of patients with an Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5- point scale) and a reduction from baseline of ≥2 points(12, 18 and 24 months)
- Absolute change from baseline Atopic Dermatitis Control Test (ADCT) score(at 16 and 24 weeks, and at 12, 18, and 24 months)
- Proportion of patients with ≤2 days per week of topical therapies applications, on average, in the last 4 weeks(at 24 weeks and at 12 months)
- Change in Eczema Area and Severity Index (EASI) score from baseline(16 weeks and at 12, 18, and 24 months)
- Proportion of patients with an EASI75 and EASI90(at 16 weeks and at 12, 18, and 24 months)
- Absolute changes from baseline score of Epworth sleepiness scale(at 2, 16, and 24 weeks, and at 12 months)
- Time to Peak Pruritis-Numerical Rate Scale (PP-NRS) response (improvement of ≥2 points from baseline)(at 2, 16 weeks)
- PP-NRS (response improvement of ≥2 points or ≥4 points from baseline)(at 2, 16, 24 weeks and at 12 months)
- Absolute change from baseline in PP-NRS score(at 2, 16, and 24 weeks, and at 12 months)
- Proportion of patient with temporary treatment discontinuation(Baseline to 24 months)
- Duration of each dosage(Baseline to 24 months)
- Duration of Drug Therapy(Baseline to 24 months)
- Proportion of patients with each regimen and changes over the treatment period(Baseline to 24 months)
- Proportion of patient with permanent treatment discontinuation with reason(Baseline up to 24 months)
- Number of Participants With Any Changes in Dosing(Baseline to 24 months)
- Demographic Characteristic of Participants: Comorbidities(Baseline)
- Proportion of Participants Receiving Subsequent Treatment(Baseline to 24 months)
- Proportion of patient with temporary treatment discontinuation with reason(Baseline to 24 months)
- Proportion of responders by items of Treatment Physician Satisfaction Questionnaire score (5-points Likert scale)(16 and 24 weeks, and at 12 months)
- Demographic Characteristic of Participants: Age(Baseline)
- Demographical Characteristics of Participants:sex(Baseline)
- Disease Characteristics of Participants: history of the disease(baseline)
- Hematological and lipid biological parameters(At baseline and 16 weeks)
- Proportion of patients with serious events(at 16 weeks, 12,18,24 months)
- Proportion of patients with non-serious adverse events(at 16 weeks, 12,18,24 months)
- Demographic Characteristic of Participants: Body Mass Index(Baseline)
- Disease Characteristics of Participants: EASI score(Baseline)
- Demographic Characteristics of Participants: history of treatment for atopic dermatitis(Baseline)
- Disease Characteristics of Participants: % of BSA involvement(Baseline)
- Disease Characteristics of Participants: PRO data(Baseline)
- Number of scratching episodes during the evening sleep period that occur pre treatment versus on treatment(At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib)
- Duration of time scratching during the evening sleep period that occur pre treatment versus on treatment(At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib)
- Compare change from pre-treatment to on-treatment measures of Total time asleep(At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib)
- Compare change from pre-treatment to on-treatment measures of Sleep onset latency(At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib)
- Compare change from pre-treatment to on-treatment measures of Wake after sleep onset and Number of wake bouts(At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib)
- Compare change from pre-treatment to on-treatment measures of sleep quantity(At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib)
- Compare change from pre-treatment to on-treatment measures of Sleep efficiency(At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib)
- Compare change from pre-treatment to on-treatment measures of Total sleep opportunity(At most 1 week before initiating abrocitinib and for 2 weeks on abrocitinib)
研究者
研究点 (56)
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