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

Официальное название

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

Обзор

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.

Первичные конечные точки

• Number of Participants Utilizing Atopic Dermatitis (AD) Treatment [Срок оценки: Baseline to up to 60 months]
• Duration of Treatment [Срок оценки: Baseline to up to 60 months]
• AD Treatment Sequences [Срок оценки: Baseline to up to 60 months]
• Number of Participants Initiating AD Treatments with Reasons [Срок оценки: Baseline to up to 60 months]
• Number of Participants Interrupting AD Treatment [Срок оценки: Baseline to up to 60 months]
• Number of Participants Discontinuing AD Treatment [Срок оценки: Baseline to up to 60 months]
• Number of Participants Switching AD Treatments [Срок оценки: Baseline to up to 60 months]
• Number of Participants Augmenting AD treatment [Срок оценки: Baseline to up to 60 months]
• Number of Participants Modifying AD Treatment Dose [Срок оценки: Baseline to up to 60 months]
• Change from Baseline in Extent and Severity of AD Measured with Eczema Area and Severity Index (EASI) [Срок оценки: Baseline to up to 60 months]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 46 центров

• 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
• … и ещё 38 центров

Китай · 11 центров

• Peking University Third Hospital-Site Number: 1560008 — Пекин
• The Eighth Affiliated Hospital, Sun Yat-sen University-Site Number: 1560006 — Шэньчжэнь
• Xiangya Hospital of Central South University-Site Number : 1560001 — Чанша
• The Second Xiangya Hospital of Central South University-Site Number: 1560014 — Чанша
• The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)-Site Number: — Xi’an
• West China Hospital, Sichuan University- Site Number: 1560003 — Чэнду
• Hangzhou First People's Hospital-Site Number: 1560004 — Ханчжоу
• The Second Affiliated Hospital of Zhejiang University School of Medicine-Site Number: 1560 — Ханчжоу
• … и ещё 3 центра

Франция · 7 центров

• 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

Италия · 4 центра

• 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

Япония · 3 центра

• 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

Испания · 3 центра

• 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

Саудовская Аравия · 2 центра

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

ОАЭ · 2 центра

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

Канада · 1 центр

• Origins Dermatology Centre-Site Number : 1240003 — Regina

Идентификаторы

NCT: NCT07290803 · OBS18388 · U1111-1311-1824

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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