Brief Summary
A long-term observational registry in patients with atopic dermatitis (AD) initiating treatment with DUPIXENT® (dupilumab)
Brief Title
Study of Patients Receiving DUPIXENT® for Atopic Dermatitis (AD)
Detailed Description
This is a prospective observational study conducted to (1) characterize the patients who receive DUPIXENT® for AD in a real world setting with respect to their medical history, socio-demographic and disease characteristics, and prior and concomitant treatments of AD; (2) characterize real world use patterns of DUPIXENT® for AD (eg, most commonly used regimens by line of therapy, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching); (3) assess the long-term effectiveness of DUPIXENT® in AD patients in a real world setting; (4) assess comorbid atopic conditions, patterns of use and effects of treatment in comorbid atopic conditions in patients who receive DUPIXENT® for AD; and (5) collect safety data on study participants
Completion Date
Completion Date Type
Estimated
Conditions
Dermatitis, Atopic
Eligibility Criteria
Key Inclusion Criteria:
* Male or female, 12 years of age or older at the baseline visit. NOTE: Adolescent patients (at least 12 years old, but less than 18 years) are eligible in the US or Canada only after DUPIXENT receives the respective country's regulatory approval for use in this age group.
* Initiating treatment with DUPIXENT® as standard-of-care for AD according to the country-specific prescribing information (Note: Participants will be screened when they received their initial prescription for DUPIXENT®).
* Willing and able to comply with study-related activities.
* Able to understand and complete study-related questionnaires.
* Provide signed informed consent or parental/legal guardian consent plus patient assent, where applicable.
Key Exclusion Criteria:
* Patients who have a contraindication to the drug according to the country-specific prescribing information label.
* Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other co-morbidities that can predictably prevent the patient from adequately completing the schedule of visits and assessments.
* 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.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
* Male or female, 12 years of age or older at the baseline visit. NOTE: Adolescent patients (at least 12 years old, but less than 18 years) are eligible in the US or Canada only after DUPIXENT receives the respective country's regulatory approval for use in this age group.
* Initiating treatment with DUPIXENT® as standard-of-care for AD according to the country-specific prescribing information (Note: Participants will be screened when they received their initial prescription for DUPIXENT®).
* Willing and able to comply with study-related activities.
* Able to understand and complete study-related questionnaires.
* Provide signed informed consent or parental/legal guardian consent plus patient assent, where applicable.
Key Exclusion Criteria:
* Patients who have a contraindication to the drug according to the country-specific prescribing information label.
* Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other co-morbidities that can predictably prevent the patient from adequately completing the schedule of visits and assessments.
* 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.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Inclusion Criteria
Inclusion Criteria:
* Male or female, 12 years of age or older at the baseline visit. NOTE: Adolescent patients (at least 12 years old, but less than 18 years) are eligible in the US or Canada only after DUPIXENT receives the respective country's regulatory approval for use in this age group.
* Initiating treatment with DUPIXENT® as standard-of-care for AD according to the country-specific prescribing information (Note: Participants will be screened when they received their initial prescription for DUPIXENT®).
* Willing and able to comply with study-related activities.
* Able to understand and complete study-related questionnaires.
* Provide signed informed consent or parental/legal guardian consent plus patient assent, where applicable.
Inclusion/
* Male or female, 12 years of age or older at the baseline visit. NOTE: Adolescent patients (at least 12 years old, but less than 18 years) are eligible in the US or Canada only after DUPIXENT receives the respective country's regulatory approval for use in this age group.
* Initiating treatment with DUPIXENT® as standard-of-care for AD according to the country-specific prescribing information (Note: Participants will be screened when they received their initial prescription for DUPIXENT®).
* Willing and able to comply with study-related activities.
* Able to understand and complete study-related questionnaires.
* Provide signed informed consent or parental/legal guardian consent plus patient assent, where applicable.
Inclusion/
Gender
All
Gender Based
false
Keywords
Eczema
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
12 Years
NCT Id
NCT03428646
Org Class
Industry
Org Full Name
Regeneron Pharmaceuticals
Org Study Id
R668-AD-1762
Overall Status
Active, not recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Prospective Observational Study of Patients Receiving DUPIXENT® for Atopic Dermatitis
Primary Outcomes
Outcome Description
Medical history
Outcome Measure
Registry Assessment: Baseline Characteristics
Outcome Time Frame
At baseline (day when DUPIXENT treatment is initiated)
Outcome Description
Socio-demographics
Outcome Measure
Registry Assessment: Baseline Characteristic
Outcome Time Frame
At baseline (day when DUPIXENT treatment is initiated)
Secondary Outcomes
Outcome Description
Percentage of BSA affected by AD assessed for each major section of the body
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Physician) Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis
Outcome Description
Measure used in clinical practice and clinical trials to assess the severity and extent of AD
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Physician) Assessment: Eczema Area and Severity Index (EASI)
Outcome Description
Questionnaire used to characterizing the severity of AD on a 4-point scale (0=No disease, 1=Minimal disease, 2=Mild disease, 3=Moderate disease, 4=Severe disease)
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Physician) Assessment: Overall Disease Severity scale
Outcome Description
Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Participant) Assessment: Patient Oriented Eczema Measure
Outcome Description
Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale.
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Participant) Assessment: Pruritus Numerical Rating Scales (NRS)
Outcome Description
Individual NRS used to rate skin pain and soreness using a 0 to 10 NRS
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Participant) Assessment: Skin Pain or Soreness NRS
Outcome Description
Individual NRS used to rate the sensation of skin feeling hot (burning sensation) using a 0 to 10 NRS
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Participant) Assessment: Skin Feeling Hot NRS
Outcome Description
Individual NRS used to rate skin sensitivity using a 0 to 10 NRS
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Participant) Assessment: Skin Sensitivity NRS
Outcome Description
Individual NRS used to report the severity of their sleep disturbance using a 0 to 10 NRS
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Participant) Assessment: Sleep Disturbance NRS
Outcome Description
Rate of overall well-being on a 5-point scale.
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Participant) Assessment: Global Assessment of Atopic Dermatitis scale
Outcome Description
Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL) in adults
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Participant) Assessment: Dermatology Life Quality Index (DLQI)
Outcome Description
Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on QOL in pediatrics.
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Participant) Assessment: Children's Dermatology Life Quality Index (CDLQI)
Outcome Description
Questionnaire to assess the impact of AD on productivity.
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Participant) Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD)
Outcome Description
Questionnaire regarding hospitalization, or emergency room/ urgent care center visits due to AD.
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Participant) Assessment: Health Care Resource Utilization Questionnaire
Outcome Description
Questionnaire to assess the impact of atopic eczema on the QOL of the parents and family members of affected children.
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Participant) Assessment: Dermatitis Family Impact Questionnaire
Outcome Description
Questionnaire to assess the number of missed school days since the last study assessment of adolescent patients (aged ≥ 12 to \< 18 years) who are enrolled in school.
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Participant) Assessment: Missed School Days
Outcome Description
5-question version of questionnaire to evaluate asthma control in registry patients with comorbid asthma.
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Participant) Assessment: Juniper Asthma Control Questionnaire (ACQ-5)
Outcome Description
Questionnaire used as a validated measuring instrument for the documentation of symptoms and therapy monitoring in AR.
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Participant) Assessment: Allergic Rhinitis Visual Analog Scale (AR-VAS)
Outcome Description
Rate of change in any other condition(s) (other than eczema, asthma, and allergic symptoms) on a 2-point scale (Better or Worse).
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Participant) Assessment: Changes in Concurrent Conditions
Outcome Description
Rate of overall state of health on a 5-point scale (Poor, Fair, Good, Very Good or Excellent).
Outcome Time Frame
Baseline to month 60
Outcome Measure
Registry (Participant) Assessment: Overall Health State
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
The target population comprises adult and adolescent patients (male or female, ≥12 years old), who are initiating treatment with DUPIXENT® for AD according to the country-specific prescribing information.
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Holly Kanavy
Investigator Email
HKanavy@montefiore.org
Investigator Phone
866-633-8255 / 718-230-2997 / 510-996-0741