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

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ClinicalTrials.gov Identifier: NCT03992417
Recruitment Status : Recruiting
First Posted : June 20, 2019
Last Update Posted : July 7, 2021
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 July 7, 2021
Actual Study Start Date June 11, 2019
Estimated Primary Completion Date April 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 19, 2021)
  • 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
 (submitted: June 18, 2019)
  • 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
 (submitted: May 19, 2021)
  • 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
 (submitted: June 18, 2019)
  • 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 Recruiting
Estimated Enrollment
 (submitted: June 18, 2019)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2026
Estimated Primary Completion Date April 2026   (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 No
Contacts
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-Us@sanofi.com
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 No
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://www.clinicalstudydatarequest.com/
Responsible Party Sanofi
Study Sponsor Sanofi
Collaborators Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date June 2021