This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment

Sanofi1,000 enrolled

Overview

The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions. The study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Atopic Dermatitis

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged more than or equal to (≥) 12 years at the time of consent. * Confirmed diagnosis of AD, of any severity, according to the Investigator's assessment as aligned with International Classification of Diseases 10th revision (ICD-10) code of L20. * Prescribed and scheduled to initiate any systemic treatment for AD (including but not limited to biologics, oral Janus kinase (JAK) inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil) * Signed informed consent for registry participation by the patient or parent/legal representative and assent by the patient appropriate to the patient's age, including willingness to participate in long-term follow-up. Exclusion Criteria: * Concurrent participation in an interventional clinical trial that administers an investigational drug that modifies patient care. * Insufficient understanding of the study by the patient and/or parent/guardian. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (37)

Cahaba Dermatology & Skin Health Center- Site Number : 8400006

Birmingham, Alabama, United States

RECRUITING

River Region Dermatology and Laser- Site Number : 8400041

Montgomery, Alabama, United States

RECRUITING

San Tan Allergy & Asthma- Site Number : 8400031

Gilbert, Arizona, United States

RECRUITING

Kern Research, Inc.- Site Number : 8400047

Bakersfield, California, United States

Outcomes

Primary Outcomes

Number of Participants Utilizing Atopic Dermatitis (AD) Treatment

The number (and percentage) of participants taking AD treatments and treatments per patient will be described.

Time frame: Baseline to up to 60 months

Duration of Treatment

The duration of AD treatments will be summarized descriptively.

Time frame: Baseline to up to 60 months

AD Treatment Sequences

The ordering of AD treatments will be summarized descriptively.

Time frame: Baseline to up to 60 months

Number of Participants Initiating AD Treatments with Reasons

The number (and percentage) of patients initiating AD treatment and reasons for initiation will be summarized descriptively.

Time frame: Baseline to up to 60 months

Number of Participants Interrupting AD Treatment

The number (and percentage) of patients interrupting AD treatment and reasons for treatment interruption will be summarized descriptively.

Time frame: Baseline to up to 60 months

Number of Participants Discontinuing AD Treatment

The number (and percentage) of patients discontinuing AD treatment and reasons for treatment discontinuation will be summarized descriptively.

Time frame: Baseline to up to 60 months

Number of Participants Switching AD Treatments

The number (and percentage) of patients switching AD treatment and reasons for treatment switch will be summarized descriptively.

Time frame: Baseline to up to 60 months

Number of Participants Augmenting AD treatment

The number (and percentage) of patients augmenting AD treatment will be summarized descriptively.

Time frame: Baseline to up to 60 months

Number of Participants Modifying AD Treatment Dose

The number (and percentage) of patients modifying AD treatment dose, reasons for dose modification, and dosing will be summarized descriptively.

Time frame: Baseline to up to 60 months

Change from Baseline in Extent and Severity of AD Measured with Eczema Area and Severity Index (EASI)

Clinical outcomes measured using EASI will be summarized at the start of a treatment episode and each follow-up time point.

Time frame: Baseline to up to 60 months

Change from Baseline in Extent and Severity of AD Measured with Body Surface Area (BSA)

Clinical outcomes measured using BSA will be summarized at the start of a treatment episode and each follow-up time point.

Time frame: Baseline to up to 60 months

Change from Baseline in Extent and Severity of AD Measured with Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD)

Clinical outcomes measured using vIGA-AD will be summarized at the start of a treatment episode and each follow-up time point.

Time frame: Baseline to up to 60 months

Change from Baseline in Extent and Severity of AD Measured with Revised Investigator's Global Assessment for Atopic Dermatitis (rIGA-AD)

Clinical outcomes measured using rIGA-AD will be summarized at the start of a treatment episode and each follow-up time point.

Time frame: Baseline to up to 60 months

Change in Atopic Dermatitis Control Test (ADCT) from Baseline

The ADCT is a 6-item patient-reported outcomes instrument with a 7-day recall period to measure AD disease control. Total score ranges from 0 to 24.

Time frame: Baseline to up to 60 months

Change in Patient Global Impression of Severity (PGIS) from Baseline

The PGIS is a single item tool used to assess current severity of eczema symptoms, scored on a 5-point scale from 1 = no symptoms to 5 = very severe symptoms.

Time frame: Baseline to up to 60 months

Change in Itch severity as Measured with the Peak Pruritus Numeric Rating Scale (PP-NRS) from Baseline

The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.

Time frame: Baseline to up to 60 months

Change in Skin Pain as Measured with Skin Pain Numeric Rating Scale (SP-NRS) from Baseline

The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD during the past 24 hours, with 0 = no pain and 10 = worst possible pain imaginable.

Time frame: Baseline to up to 60 months

Change in Sleep Disturbance as Measured with Sleep Disturbance Numeric Rating Scale (SD-NRS) from Baseline

The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD, with 0 being 'no sleep loss related to the symptoms of atopic dermatitis' and 10 being 'I did not sleep at all' due to the symptoms of atopic dermatitis.

Time frame: Baseline to up to 60 months

Remission of AD

Total remission of all signs and symptoms of AD will be assessed.

Time frame: Baseline to up to 60 months

Secondary Outcomes

Sociodemographic characteristics of Participants

Demographics characteristics including age, sex, body weight, height, geographic region, education level, employment status, smoking and alcohol status will be collected.

Time frame: Baseline

Ethnic Origin in Combination with Fitzpatrick Scale

The Fitzpatrick Skin Type Scale was developed based on an individual's reaction to sun exposure and will be completed by the Investigator. Skin types range from I - VI, with scores of I indicating the palest skin tone with no inherent melanin pigmentation, and VI indicating the darkest skin tone with significant amount of melanin.

Time frame: Baseline

Disease characteristics of Participants

History of AD (including date of diagnosis, age of onset, specialty of provider who diagnosed condition), AD morphology, including but not limited to, patches, plaques, prurigo nodules, lichenoid papules, perifollicular papules, nummular lesions, and psoriasiform lesions and family history of AD and comorbidities will be collected.

Time frame: Baseline

Change from Baseline in Dermatology-specific Quality of Life Measure with Dermatology Life Quality Index (DLQI)

DLQI is calculated by summing the score of each question resulting in a maximum score of 30 and a minimum score of 0 (higher scores indicate quality of life is more impaired).

Time frame: Baseline to up to 60 months

Change from Baseline in Dermatology-specific Quality of Life Measure with Children's Dermatology Life Quality Index (CDLQI)

The CDLQI is calculated by summing the score of each question resulting in a maximum score of 30 and a minimum score of 0 (higher scores indicate quality of life is more impaired).

Time frame: Baseline to up to 60 months

Change from Baseline in Burden of Assessment Using Patient Health Questionnaire-9 (PHQ-9)

PHQ-9 is a 9-item, validated, patient-reported questionnaire to assess depression which scores each of the 9 Diagnostic and Statistical Manual of Mental Disorders-IV criteria as "0" (not at all) to "3" (nearly every day). Possible scores range from 0 to 27 and are classified as 1-4: "minimal depression"; 5-9: "mild depression"; 10-14: "moderate depression"; 15-19: "moderately severe depression"; and 20-27: "severe depression".

Central Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610 Contact-US@sanofi.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Center for Dermatology Clinical Research- Site Number : 8400014

Fremont, California, United States

RECRUITING

Dermatology Research Associates - Los Angeles- Site Number : 8400020

Los Angeles, California, United States

RECRUITING

Northridge Clinical Trials, LLC- Site Number : 8400009

Northridge, California, United States

RECRUITING

Sunwise Clinical Research, LLC.- Site Number : 8400010

Oakland, California, United States

RECRUITING

Empire Clinical Research, LLC- Site Number : 8400007

Pomona, California, United States

RECRUITING

University Clinical Trials- Site Number : 8400019

San Diego, California, United States

RECRUITING

...and 27 more locations

Time frame: Baseline to up to 60 months

Change from Baseline in AD Specific Work and Classroom Productivity and Impairment Assessed Using WPAI+CIQ

Work Productivity and Activity Impairment plus Classroom Impairment Questions (WPAI+CIQ) is a 10-item, patient-reported, validated questionnaire adapted for AD to measure impairments in work, classroom, and regular daily activities over a 7-day period.

Time frame: Baseline to up to 60 months

Change from Baseline in Treatment Satisfaction Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM-9)

The 14-item TSQM-9 is a generic measure of treatment satisfaction, assessing side effects, effectiveness, convenience and global satisfaction, over the last 2 to 3 weeks, or since the patient has last used it. A lower score indicates lower satisfaction with treatment.

Time frame: Baseline to up to 60 months

Visits with Specialty of Attending Healthcare Provider and Reason for Visit

Health care resource utilization including visits with specialty of attending health care provider and reason for visit (example, disease flare-up, regular visit, prescription change, adverse event \[AE\]) will be assessed.

Time frame: Baseline to up to 60 months

Hospitalizations for AD

Hospitalization for AD will be assessed.

Time frame: Baseline to up to 60 months

Prevalence of Comorbid Atopic Conditions

Prevalence of comorbid atopic conditions (including but not limited to, asthma, allergic conjunctivitis, allergic rhinitis, eosinophilic esophagitis, nasal polyposis, food allergy, prurigo nodularis, chronic spontaneous urticaria, and rhinoconjunctivitis) and non-atopic conditions (including but not limited to, insomnia, anxiety, attention deficit disorder, depression, major adverse cardiovascular event, cardiovascular disease, skin infection, pulmonary disease, osteoporosis, fractures, contact allergy, and inflammatory conditions) will be assessed.

Time frame: Baseline to up to 60 months

Incidence of Comorbid Atopic Conditions

Incidence of comorbid atopic conditions (including but not limited to, asthma, allergic conjunctivitis, allergic rhinitis, eosinophilic esophagitis, nasal polyposis, food allergy, prurigo nodularis, chronic spontaneous urticaria, and rhinoconjunctivitis) and non-atopic conditions (including but not limited to, insomnia, anxiety, attention deficit disorder, depression, major adverse cardiovascular event, cardiovascular disease, skin infection, pulmonary disease, osteoporosis, fractures, contact allergy, and inflammatory conditions) will be assessed.

Time frame: Baseline to up to 60 months

Change from Baseline in Asthma Control Assessed with Asthma Control Questionnaire-5 (ACQ-5)

ACQ-5 is a 5-item questionnaire used to assess asthma control \[33\]. Each question is rated on a 7-point scale (0=no impairment; 6=maximum impairment). The ACQ-5 score is calculated using the mean of the 5 items and ranges between 0 (well controlled asthma) to 6 (extremely poorly controlled asthma). The ACQ-5 will only be completed by patients with comorbid asthma.

Time frame: Baseline to up to 60 months

Occurrence of Concomitant Medication use for AD and Selected Comorbidities

The occurrence of concomitant medication use for AD and selected comorbidities at baseline and changes (including reason for change) will be summarized.

Time frame: Baseline to up to 60 months

Number of Adverse Events (SAEs)

Number of patients experiencing AEs.

Time frame: Baseline to up to 60 months

Number of Serious Adverse Events (SAEs)

Number of patients experiencing SAEs.

Time frame: Baseline to up to 60 months