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Trial record 2 of 72 for:    regeneron | Recruiting, Not yet recruiting, Available Studies

Study of Adult Patients Receiving DUPIXENT® for Atopic Dermatitis (AD) (PROSE)

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ClinicalTrials.gov Identifier: NCT03428646
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
A long-term observational registry in patients with atopic dermatitis initiating treatment with DUPIXENT® (dupilumab)

Condition or disease Intervention/treatment
Dermatitis, Atopic Drug: Dupilumab

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 adult AD patients in a real world setting; (4) assess comorbid atopic conditions, patterns of use and effects of treatment in comorbid atopic conditions in adult patients who receive DUPIXENT® for AD; and (6) collect safety data on study participants

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 60 Months
Official Title: A Prospective Observational Study of Adult Patients Receiving DUPIXENT® for Atopic Dermatitis
Actual Study Start Date : April 6, 2018
Estimated Primary Completion Date : December 2, 2023
Estimated Study Completion Date : December 2, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Dupilumab
U.S. FDA Resources


Intervention Details:
    Drug: Dupilumab
    In addition to (or substituting for) DUPIXENT®, participants may receive marketed drugs as deemed necessary by their physicians for the treatment of AD or comorbid conditions.
    Other Names:
    • DUPIXENT®
    • REGN668


Primary Outcome Measures :
  1. Registry Assessment: Baseline Characteristics [ Time Frame: At baseline (day when DUPIXENT treatment is initiated) ]
    Medical history

  2. Registry Assessment: Baseline Characteristic [ Time Frame: At baseline (day when DUPIXENT treatment is initiated) ]
    Socio-demographics


Secondary Outcome Measures :
  1. Registry (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

  2. Registry (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

  3. Registry (Physician) Assessment: Overall Disease Severity scale [ Time Frame: Baseline to month 60 ]
    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)

  4. Registry (Participant) Assessment: Patient Oriented Eczema Measure [ Time Frame: Baseline to month 60 ]
    Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults

  5. Registry (Participant) Assessment: Pruritus Numerical Rating Scales (NRS) [ Time Frame: Baseline to month 60 ]
    Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale

  6. Registry (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

  7. Registry (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

  8. Registry (Participant) Assessment: Skin Sensitivity NRS [ Time Frame: Baseline to month 60 ]
    Individual NRS used to rate skin sensitivity using a 0 to 10 NRS

  9. Registry (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

  10. Registry (Participant) Assessment: Global Assessment of Atopic Dermatitis scale [ Time Frame: Baseline to month 60 ]
    Rate of overall well-being on a 5-point scale

  11. Registry (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)

  12. Registry (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

  13. Registry (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


Biospecimen Retention:   Samples With DNA
Optional sub-study: Blood samples will be collected at the scheduled visits and stored up to 10 years for future use in bio-marker research. Participants who agree to provide blood samples for future research will be required to sign a separate informed consent form (ICF) before collection of the samples.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population is adult patients (male or female, ≥18 years old), who are initiating treatment with DUPIXENT® for AD according to the country-specific prescribing information.
Criteria

Inclusion Criteria:

  1. Initiating treatment with DUPIXENT® for AD according to the country-specific prescribing information (Note: Participants will be screened when they received their initial prescription for DUPIXENT®)
  2. Willing and able to comply with the study-related activities
  3. Able to understand and complete study-related questionnaires
  4. Provide signed informed consent

Exclusion Criteria:

  1. Patients who have a contraindication to the drug according to the country-specific prescribing information label.
  2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428646


Contacts
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
United States, Maryland
Regeneron Investigational Site Recruiting
Rockville, Maryland, United States, 20850
United States, Texas
Regeneron Investigational Site Recruiting
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Medical Affairs Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03428646     History of Changes
Other Study ID Numbers: R668-AD-1762
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Regeneron Pharmaceuticals:
Eczema

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases