A Prospective Observational Study of Patients Receiving Dupilumab for Prurigo Nodularis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Sanofi
- 入组人数
- 100
- 试验地点
- 49
- 主要终点
- Frequency of reasons for dupilumab treatment initiation with the description of dosing, frequency and duration of treatment
研究概览
简要总结
This study is a prospective, multinational, observational investigation designed to elucidate the real-world effectiveness and treatment patterns of dupilumab therapy in adult patients diagnosed with prurigo nodularis (PN).
The primary objective of this study is to comprehensively characterize the real-world usage of dupilumab for the management of PN.
In addition to this, the study aims to achieve several secondary objectives, including a detailed assessment of the medical history, socio-demographic and disease characteristics of dupilumab-treated PN patients, as well as the evaluation of the long-term real-world effectiveness of dupilumab therapy for PN.
详细描述
The follow-up period will be 18 months or until death, loss to follow-up, or withdrawal, whichever comes first.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 aged 18 years or older at the time of informed consent.
- •Physician decision to treat the patient with dupilumab for prurigo nodularis (according to the country-specific prescribing information) made prior to and independently of the patient's participation in the study.
- •Patients able to understand and complete study-related questionnaires.
- •Patients provide voluntary informed consent to participate in the study before inclusion in the study.
排除标准
- •Patients who have a contraindication to dupilumab according to the country-specific prescribing information label.
- •Any condition that, in the opinion of the Investigator, may interfere with the patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from completing the schedule of visits and assessments.
- •Patients currently participating in any interventional clinical trial.
- •Prior use of dupilumab within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day.
研究组 & 干预措施
Patient with prurigo nodularis
Participants aged 18 years or older who start receiving dupilumab for prurigo nodularis (according to the country-specific prescribing information) prior to and independently of their participation in the study
干预措施: Dupilumab (Drug)
结局指标
主要结局
Frequency of reasons for dupilumab treatment initiation with the description of dosing, frequency and duration of treatment
时间窗: At baseline
Frequency of reasons for dupilumab treatment modifications with the description of the modified treatment
时间窗: From baseline up to month 18
Proportion of patients who discontinued dupilumab
时间窗: From baseline up to month 18
Frequency of reasons for dupilumab treatment discontinuation
时间窗: From baseline up to month 18
Proportion of patients hospitalized due to PN
时间窗: From baseline up to month 18
次要结局
- Proportion of patients with PGIC score of "Very much better (improved)" or "Moderately better (improved)"(From baseline up to month 18)
- Baseline Characteristics: PN-related medical history(At baseline)
- Baseline Characteristics: Socio-demographics of PN patients(At baseline)
- Baseline Characteristics: Type of PN therapies received prior to initiation of dupilumab treatment(At baseline)
- Proportion of patients using concomitant medication(At baseline)
- Proportion of patients with a ≥ four-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS)(From baseline up to month 18)
- Mean change in WI-NRS(From baseline up to month 18)
- Proportion of patients with a ≥ four-point improvement (reduction) in Skin Pain Numeric Rating Scale (NRS)(From baseline up to month 18)
- Mean change in Skin Pain NRS(From baseline up to month 18)
- Proportion of patients with a ≥ two-point improvement (reduction) in Sleep Disturbance Numeric Rating Scale (NRS)(From baseline up to month 18)
- Mean change in Sleep Disturbance NRS(From baseline up to month 18)
- Proportion of patients with Patient Global Impression of Change of PN Disease (PGIC) score of "Very much better (improved)"(From baseline up to month 18)
- Mean change in PGIC(From baseline up to month 18)
- Proportion of patients with Patient Global Impression of Severity of PN Disease (PGIS) score of "None"(From baseline up to month 18)
- Proportion of patients with PGIS score of "None" or "Mild"(From baseline up to month 18)
- Mean change in PGIS(From baseline up to month 18)
- Mean change in Dermatology Life Quality Index (DLQI)(From baseline up to month 18)
- Mean change in Pruritus Activity Score (PAS)(From baseline up to month 18)
- Proportion of patients with Investigator's Global Assessment-chronic prurigo Activity (IGA-CPG Activity) score of 0 or 1(From baseline up to month 18)
- Mean change in IGA-CPG Activity(From baseline up to month 18)
- Proportion of patients with Investigator's Global Assessment-chronic prurigo Stage (IGA-CPG Stage) score of 0 or 1(From baseline up to month 18)
- Mean change in IGA-CPG Stage(From baseline up to month 18)
- Mean change in EQ-5D-5L(From baseline up to month 18)
- Mean change in Hospital Anxiety and Depression Scale (HADS) total score(From baseline up to month 18)
- Proportion of patients reported working, absenteeism score, presenteeism score, and overall impairment working score using the Work Productivity and Activity Impairment (WPAI) questionnaire(From baseline up to month 18)
- Percentage of patients experiencing AEs and SAEs(From baseline up to month 18)