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

Official title

Atopic Dermatitis Disease Registry of Adult and Adolescent Patients Initiating or Switching Systemic Treatments

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.

Primary outcome measures

• Number of Participants Utilizing Atopic Dermatitis (AD) Treatment [Time frame: Baseline to up to 60 months]
• Duration of Treatment [Time frame: Baseline to up to 60 months]
• AD Treatment Sequences [Time frame: Baseline to up to 60 months]
• Number of Participants Initiating AD Treatments with Reasons [Time frame: Baseline to up to 60 months]
• Number of Participants Interrupting AD Treatment [Time frame: Baseline to up to 60 months]
• Number of Participants Discontinuing AD Treatment [Time frame: Baseline to up to 60 months]
• Number of Participants Switching AD Treatments [Time frame: Baseline to up to 60 months]
• Number of Participants Augmenting AD treatment [Time frame: Baseline to up to 60 months]
• Number of Participants Modifying AD Treatment Dose [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) [Time frame: Baseline to up to 60 months]

Secondary outcome measures (12)

• Sociodemographic characteristics of Participants [Time frame: Baseline]
• Ethnic Origin in Combination with Fitzpatrick Scale [Time frame: Baseline]
• Disease characteristics of Participants [Time frame: Baseline]
• Change from Baseline in Dermatology-specific Quality of Life Measure with Dermatology Life Quality Index (DLQI) [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) [Time frame: Baseline to up to 60 months]
• Change from Baseline in Burden of Assessment Using Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline to up to 60 months]
• Change from Baseline in AD Specific Work and Classroom Productivity and Impairment Assessed Using WPAI+CIQ [Time frame: Baseline to up to 60 months]
• Change from Baseline in Treatment Satisfaction Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM-9) [Time frame: Baseline to up to 60 months]
• Visits with Specialty of Attending Healthcare Provider and Reason for Visit [Time frame: Baseline to up to 60 months]
• Hospitalizations for AD [Time frame: Baseline to up to 60 months]
• Prevalence of Comorbid Atopic Conditions [Time frame: Baseline to up to 60 months]
• Incidence of Comorbid Atopic Conditions [Time frame: Baseline to up to 60 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 46 centers

• Cahaba Dermatology & Skin Health Center- Site Number : 8400006 — Birmingham
• River Region Dermatology and Laser- Site Number : 8400041 — Montgomery
• San Tan Allergy & Asthma- Site Number : 8400031 — Gilbert
• Saguaro Dermatology- Site Number : 8400028 — Phoenix
• Kern Research, Inc.- Site Number : 8400047 — Bakersfield
• Center for Dermatology Clinical Research- Site Number : 8400014 — Fremont
• Dermatology Research Associates - Los Angeles- Site Number : 8400020 — Los Angeles
• Northridge Clinical Trials, LLC- Site Number : 8400009 — Northridge
• … and 38 more centers

China · 11 centers

• Peking University Third Hospital-Site Number: 1560008 — Beijing
• The Eighth Affiliated Hospital, Sun Yat-sen University-Site Number: 1560006 — Shenzhen
• Xiangya Hospital of Central South University-Site Number : 1560001 — Changsha
• The Second Xiangya Hospital of Central South University-Site Number: 1560014 — Changsha
• The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)-Site Number: — Xi’an
• West China Hospital, Sichuan University- Site Number: 1560003 — Chengdu
• Hangzhou First People's Hospital-Site Number: 1560004 — Hangzhou
• The Second Affiliated Hospital of Zhejiang University School of Medicine-Site Number: 1560 — Hangzhou
• … and 3 more centers

France · 7 centers

• CHU Besançon - Hôpital Jean Minjoz-Site Number: 2500010 — Besançon
• Centre Hospitalier de Valence-Site Number: 2500005 — Valence
• GHRMSA - Hospital Emile Muller-Site Number : 2500006 — Mulhouse
• CHU de La Reunion-Site Number: 2500007 — Saint-Pierre
• Hopitaux Drome Nord-Site Number : 2500002 — Romans-sur-Isère
• Centre Hospitalier William Morey-Site Number: 2500008 — Chalon-sur-Saône
• Centre Hospitalier du Mans-Site Number: 2500004 — Le Mans

Italy · 4 centers

• Azienda Ospedaliero Universitaria delle Marche-Site Number: 3800009 — Ancona
• Ospedale Maggiore di Novara-Site Number: 3800005 — Novara
• Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia-Site Number : 3800006 — Reggio Emilia
• Istituto San Gallicano IRCCS - Istituti Fisioterapici Ospitalieri-Site Number: 3800002 — Roma

Japan · 3 centers

• Takeoka Dermatology Clinic- Site Number : 3920005 — Marugame-shi
• Osaka Habikino Medical Center-Site Number : 3920001 — Habikino-shi
• JA-Shizuoka Enshu Hospital-Site Number: 3920003 — Hamamatsu

Spain · 3 centers

• Hospital Universitario de Canarias-Site Number: 7240008 — Santa Cruz de Tenerife
• Hospital General Universitario Dr. Balmis-Site Number: 7240005 — Alicante
• Investigational Site Number: 7240006 — Barcelona

Saudi Arabia · 2 centers

• King Saud University-Site Number: 6820004 — Riyadh
• King Fahad Medical City-Site Number : 6820001 — Riyadh

United Arab Emirates · 2 centers

• Mediclinic Hospital, AUH-Site Number: 7840004 — Abu Dhabi
• Dr Joseph Polyclinic Amber Clinic-Site Number: 7840005 — Al Karama

Canada · 1 center

• Origins Dermatology Centre-Site Number : 1240003 — Regina

Identifiers

NCT: NCT07290803 · OBS18388 · U1111-1311-1824

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗