Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD) (GLOBOSTAD)

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ClinicalTrials.gov Identifier: NCT03992417

Recruitment Status : Active, not recruiting

First Posted : June 20, 2019

Last Update Posted : May 9, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Regeneron Pharmaceuticals

Information provided by (Responsible Party):

Sanofi

Tracking Information

First Submitted Date

June 18, 2019

First Posted Date

June 20, 2019

Last Update Posted Date

May 9, 2022

Actual Study Start Date

June 11, 2019

Estimated Primary Completion Date

March 31, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

Baseline Characteristics: Medical history [ Time Frame: Baseline to Month 60 ]
Baseline Characteristics: Socio-demographics [ Time Frame: Baseline to Month 60 ]
Baseline Characteristics: Disease characteristics [ Time Frame: Baseline to Month 60 ]

Original Primary Outcome Measures

Baseline Characteristics [ Time Frame: At baseline (day when Duplixent® treatment is initiated) ]
Medical history
Baseline Characteristics [ Time Frame: At baseline (day when Duplixent® treatment is initiated) ]
Socio-demographics

Change History

Current Secondary Outcome Measures

Physician Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis [ Time Frame: Baseline to Month 60 ]
Percentage of BSA affected by AD assessed for each major section of the body
Physician Assessment: Eczema Area and Severity Index (EASI) [ Time Frame: Baseline to Month 60 ]
Measure used in clinical practice and clinical trials to assess the severity and extent of AD
Physician Assessment: Scoring of Atopic Dermatitis (SCORAD) [ Time Frame: Baseline to Month 60 ]
Measure used in clinical practice and clinical trials to standardize the evaluation of the severity and extent of AD
Participant Assessment: Patient Oriented Eczema Measure (POEM) [ Time Frame: Baseline to Month 60 ]
Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults
Participant Assessment: Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline to Month 60 ]
Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale
Participant Assessment: Skin Pain or Soreness NRS [ Time Frame: Baseline to Month 60 ]
Individual NRS used to rate skin pain and soreness using a 0 to 10 NRS
Participant Assessment: Skin Feeling Hot NRS [ Time Frame: Baseline to Month 60 ]
Individual NRS used to rate the sensation of skin feeling hot (burning sensation) using a 0 to 10 NRS
Participant Assessment: Skin Sensitivity NRS [ Time Frame: Baseline to Month 60 ]
Individual NRS used to rate skin sensitivity using a 0 to 10 NRS
Participant Assessment: Sleep Disturbance NRS [ Time Frame: Baseline to Month 60 ]
Individual NRS used to report the severity of their sleep disturbance using a 0 to 10 NRS
Participant Assessment: Dermatology Life Quality Index (DLQI) for adults and Children Dermatology Life Quality Index (CDLQI) for adolescents [ Time Frame: Baseline to Month 60 ]
Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL)
Participant Assessment: Juniper Asthma Control Questionnaire (ACQ-5) [ Time Frame: Baseline to Month 60 ]
Questionnaire to evaluate asthma control in participants with comorbid asthma
Participant Assessment: Allergic Rhinitis-Visual Analog Scale (AR-VAS) [ Time Frame: Baseline to Month 60 ]
Instrument for the documentation of symptoms and therapy monitoring in allergic rhinitis
Participant Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD) for adults and Work Productivity and Activity Impairment Questionnaire+Classroom Impairment Questions for AD (WPAI-CIQ-AD) for adolescents [ Time Frame: Baseline to Month 60 ]
Questionnaire to assess the impact of AD on productivity
Participant Assessment: Health Care Resource Utilization Questionnaire [ Time Frame: Baseline to Month 60 ]
Questionnaire regarding hospitalization, or emergency room/urgent care center visits due to AD
Participant Assessment: 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9) [ Time Frame: Baseline to Month 60 ]
Instrument to measure treatment satisfaction
Adverse events (AEs) [ Time Frame: Baseline to Month 60 ]
Number of participants with at least 1 AE
Participant Assessment: Atopic Dermatitis Control Tool (ADCT) to be collected optionally [ Time Frame: Baseline to Month 60 ]
Questionnaire related with Atopic dermatitis control

Original Secondary Outcome Measures

Physician Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis [ Time Frame: Baseline to Month 60 ]
Percentage of BSA affected by AD assessed for each major section of the body
Physician Assessment: Eczema Area and Severity Index (EASI) [ Time Frame: Baseline to Month 60 ]
Measure used in clinical practice and clinical trials to assess the severity and extent of AD
Physician Assessment: Scoring of Atopic Dermatitis (SCORAD) [ Time Frame: Baseline to Month 60 ]
Measure used in clinical practice and clinical trials to standardize the evaluation of the severity and extent of AD
Participant Assessment: Patient Oriented Eczema Measure (POEM) [ Time Frame: Baseline to Month 60 ]
Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults
Participant Assessment: Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline to Month 60 ]
Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale
Participant Assessment: Skin Pain or Soreness NRS [ Time Frame: Baseline to Month 60 ]
Individual NRS used to rate skin pain and soreness using a 0 to 10 NRS
Participant Assessment: Skin Feeling Hot NRS [ Time Frame: Baseline to Month 60 ]
Individual NRS used to rate the sensation of skin feeling hot (burning sensation) using a 0 to 10 NRS
Participant Assessment: Skin Sensitivity NRS [ Time Frame: Baseline to Month 60 ]
Individual NRS used to rate skin sensitivity using a 0 to 10 NRS
Participant Assessment: Sleep Disturbance NRS [ Time Frame: Baseline to Month 60 ]
Individual NRS used to report the severity of their sleep disturbance using a 0 to 10 NRS
Participant Assessment: Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline to Month 60 ]
Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL)
Participant Assessment: Juniper Asthma Control Questionnaire (ACQ-5) [ Time Frame: Baseline to Month 60 ]
Questionnaire to evaluate asthma control in participants with comorbid asthma
Participant Assessment: Allergic Rhinitis-Visual Analog Scale (AR-VAS) [ Time Frame: Baseline to Month 60 ]
Instrument for the documentation of symptoms and therapy monitoring in allergic rhinitis
Participant Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD) [ Time Frame: Baseline to Month 60 ]
Questionnaire to assess the impact of AD on productivity
Participant Assessment: Health Care Resource Utilization Questionnaire [ Time Frame: Baseline to Month 60 ]
Questionnaire regarding hospitalization, or emergency room/urgent care center visits due to AD
Participant Assessment: 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9) [ Time Frame: Baseline to Month 60 ]
Instrument to measure treatment satisfaction
Adverse events (AEs) [ Time Frame: Baseline to Month 60 ]
Number of participants with at least 1 AE

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD)

Official Title

A Prospective Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis

Brief Summary

Primary Objective:

To characterize the patients who receive Dupixent® (dupilumab) 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

Secondary Objectives:

To characterize real-world use patterns of Dupixent® for AD (eg, used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching)
To assess the long-term effectiveness of Dupixent® in AD patients in a real-world setting
To assess comorbid atopic conditions and effects of treatment in comorbid atopic conditions in patients who receive Dupixent® for AD
To collect safety data on study participants

Detailed Description

Participants enrolled in the study will be followed for 5 years.

Study Type

Observational [Patient Registry]

Study Design

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

60 Months

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

The target population is 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.

Condition

Dermatitis Atopic

Intervention

Drug: Dupilumab SAR231893 (REGN668)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Other Name: Dupixent®

Study Groups/Cohorts

Participants with AD

Adult and adolescent participants with AD initiating treatment with Dupixent® for AD according to the country-specific prescribing information, as part of their usual care as determined by their physician

Intervention: Drug: Dupilumab SAR231893 (REGN668)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Active, not recruiting

Actual Enrollment

897

Original Estimated Enrollment

1000

Estimated Study Completion Date

March 31, 2027

Estimated Primary Completion Date

March 31, 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Male or female, 12 years or older at the baseline visit. Note: Adolescent participants (at least 12 years old, but less than 18 years) are eligible only after Dupixent® receives the respective country's regulatory approval for use in this age group;
Initiating treatment with Dupixent® for AD according to the country-specific prescribing information. Note: Participants may be eligible if they have already initiated treatment with Dupixent® for AD within 6 months before their enrollment in the registry, provided that all core baseline data required (Eczema Area and Severity Index [EASI], Scoring of Atopic Dermatitis [SCORAD], body surface area [of AD involvement] [BSA], Patient-Oriented Eczema Measure [POEM], and Dermatology Life Quality Index [DLQI]) by the registry protocol were captured at the time of initiating Dupixent® treatment and are available for entry in the registry database
Able to understand and complete study-related questionnaires
Provide signed informed consent or parental/legally acceptable representative consent and/or patient assent where applicable

Exclusion Criteria:

Participants 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 participant patient from adequately completing the schedule of visits and assessments
Patients currently participating in any interventional clinical trial which modifies patient care
Prior use of Dupixent® within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sex/Gender

Sexes Eligible for Study:

All

Ages

12 Years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

Argentina, Australia, Austria, Belgium, Colombia, Czechia, Finland, France, Greece, Israel, Italy, Japan, Kuwait, Mexico, Netherlands, Norway, Portugal, Russian Federation, Saudi Arabia, Spain, Taiwan, United Arab Emirates

Removed Location Countries

Administrative Information

NCT Number

NCT03992417

Other Study ID Numbers

OBS15990

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Plan to Share IPD:

Yes

Plan Description:

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Current Responsible Party

Sanofi

Original Responsible Party

Same as current

Current Study Sponsor

Sanofi

Original Study Sponsor

Same as current

Collaborators

Regeneron Pharmaceuticals

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi

PRS Account

Sanofi

Verification Date

May 2022

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