Real-World Effectiveness of Dupilumab in Patients With Prurigo Nodularis: An Observational Study
Investigation of Investigational Medication Effectiveness in Prurigo Nodularis
Study Overview
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.
Study Details
The follow-up period will be 18 months or until death, loss to follow-up, or withdrawal, whichever comes first.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Prurigo Nodularis
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
This study investigates the effectiveness of an investigational medication in adults with prurigo nodularis (PN). The purpose of this observational study is to gather real-world data on how the medication is used and its impact on patients with PN. An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment, which may focus on people using specific medications or having certain conditions to better understand how treatments work.
Participants in the study will be observed over time to assess the long-term effectiveness of the investigational medication. The study will also collect information on the medical history and demographic details of the participants. This will help in understanding the treatment patterns and outcomes for patients with PN receiving this medication.
- Who can participate: Adults aged 18 years and older who have been prescribed the investigational medication for prurigo nodularis can participate. Participants must be able to understand and complete study-related questionnaires and provide informed consent. Those with a contraindication to the medication or involved in other clinical trials are excluded.
- Study details: Participants will continue with their prescribed treatment for prurigo nodularis while their progress is observed. They will complete questionnaires to provide data on their condition and treatment outcomes. This study does not involve any changes to their prescribed treatment.
- Study timelines: The study will last 18 months.
