Observational Evaluation of Atopic Dermatitis in Pediatric Patients

Dermatitis Atopic Clinical Trial

— PEDISTAD  

Official title:

Prospective, Observational, Longitudinal Study in Pediatric Patients With Moderate to Severe Atopic Dermatitis Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03687359
• Other study ID #: OBS15333
• Secondary ID: U1111-1211-9437
• Status: Recruiting
• Start date: August 15, 2019
• Est. completion date: April 21, 2036

Study information

• Verified date: December 2023
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free number for US &
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Primary Objectives:

• To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable.

• To evaluate the time-course of AD and selected atopic comorbidities.

Secondary Objectives:

• To characterize disease burden and unmet need.

• To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching).

• To document the real-world effectiveness and safety of treatments.

Description:

The study duration is 60 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1856
• Est. completion date: April 21, 2036
• Est. primary completion date: April 21, 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 11 Years

Eligibility

Inclusion criteria:

• Patients with moderate to severe AD, according to the Investigator's assessment;

• Currently receiving systemic treatment (including phototherapy) for atopic dermatitis or currently on topical treatment, but otherwise candidates for systemic treatment.

Exclusion criteria:

• Concurrent participation in an interventional clinical trial which modifies patient care.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis Atopic
• Dermatitis, Atopic

Intervention

Other:
• Standard of care
Treatment as per standard practice

Locations

Country	Name	City	State
Argentina	Investigational Site Number : 0320003	Buenos Aires
Argentina	Investigational Site Number : 0320001	Ciudad Autonoma Bs As
Argentina	Investigational Site Number : 0320005	Ciudad Autonoma Buenos Aires
Argentina	Investigational Site Number : 0320006	Ciudad Autonoma de Buenos Aire	Buenos Aires
Argentina	Investigational Site Number : 0320002	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Investigational Site Number : 0320004	Rosario	Santa Fe
Argentina	Investigational Site Number : 0320007	San Miguel de Tucuman
Australia	Investigational Site Number : 0360010	Box Hill	Victoria
Australia	Investigational Site Number : 0360009	Campbelltown	New South Wales
Australia	Investigational Site Number : 0360004	Fremantle	Western Australia
Australia	Investigational Site Number : 0360008	Kogarah	New South Wales
Australia	Investigational Site Number : 0360003	Parkville	Victoria
Australia	Investigational Site Number : 0360007	Richmond	Victoria
Australia	Investigational Site Number : 0360001	Westmead	New South Wales
Brazil	HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760004	Curitiba	Paraná
Brazil	HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760005	Curitiba	Paraná
Brazil	Universidade Federal do Paraná Site Number : 0760003	Curitiba	Paraná
Brazil	Irmandade da Santa Casa de Misericórdia de Porto Alegre Site Number : 0760002	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Sao Paulo Site Number : 0760006	São Paulo	São Paulo
Brazil	Clínica de Alergia Martti Antila Site Number : 0760001	Sorocaba
Canada	Investigational Site Number : 1240004	Calgary	Alberta
Canada	Investigational Site Number : 1240007	Calgary	Alberta
Canada	Investigational Site Number : 1240001	Markham	Ontario
Canada	Investigational Site Number : 1240006	Montreal	Quebec
Canada	Investigational Site Number : 1240009	Regina	Saskatchewan
Canada	Investigational Site Number : 1240008	Toronto	Ontario
Canada	Investigational Site Number : 1240005	Winnipeg	Manitoba
China	Investigational Site Number : 1560004	Beijing
China	Investigational Site Number : 1560006	Changsha
China	Investigational Site Number : 1560001	Chongqing
China	Investigational Site Number : 1560012	Guangzhou
China	Investigational Site Number : 1560007	Harbin
China	Investigational Site Number : 1560003	Kunming
China	Investigational Site Number : 1560011	Shenzhen
China	Investigational Site Number : 1560002	Suzhou
China	Investigational Site Number : 1560008	Xuzhou
Colombia	Investigational Site Number : 1700006	Barranquilla
Colombia	Investigational Site Number : 1700001	Bogota
Colombia	Investigational Site Number : 1700004	Bogota
Colombia	Investigational Site Number : 1700007	Bogota
Denmark	Investigational Site Number : 2080002	Kobenhavn Nv
France	Investigational Site Number : 2500008	Argenteuil Cedex
France	Investigational Site Number : 2500001	Bordeaux
France	Investigational Site Number : 2500010	Lille cedex
France	Investigational Site Number : 2500006	Marseille cedex 5
France	Investigational Site Number : 2500005	Martigues
France	Investigational Site Number : 2500002	Nantes Cedex 1
France	Investigational Site Number : 2500003	Paris Cedex 15
France	Investigational Site Number : 2500004	Saint-Etienne Cedex 2
Greece	Investigational Site Number : 3000001	Athens
Greece	Investigational Site Number : 3000004	Larissa
Greece	Investigational Site Number : 3000002	Thessaloniki
Greece	Investigational Site Number : 3000003	Thessaloniki
Israel	Investigational Site Number : 3760003	Beer Sheva
Israel	Investigational Site Number : 3760004	Haifa
Israel	Investigational Site Number : 3760005	Kfar-Saba
Israel	Investigational Site Number : 3760001	Ramat Gan
Israel	Investigational Site Number : 3760002	Rehovot
Italy	Investigational Site Number : 3800012	Bari
Italy	Investigational Site Number : 3800003	Bologna
Italy	Investigational Site Number : 3800010	Catania
Italy	Investigational Site Number : 3800001	Milano
Italy	Investigational Site Number : 3800008	Naples	Napoli
Italy	Investigational Site Number : 3800005	Napoli
Italy	Investigational Site Number : 3800011	Padova
Italy	Investigational Site Number : 3800006	Padua	Veneto
Italy	Investigational Site Number : 3800009	Perugia
Italy	Investigational Site Number : 3800004	Terracina	Latina
Italy	Investigational Site Number : 3800007	Trieste
Japan	Investigational Site Number : 3920011	Fuchu-shi	Tokyo
Japan	Investigational Site Number : 3920018	Fukuoka-shi
Japan	Investigational Site Number : 3920017	Fukuyama-shi
Japan	Investigational Site Number : 3920003	Habikino-shi	Osaka-Fu
Japan	Investigational Site Number : 3920002	Hiroshima-shi	Hiroshima
Japan	Investigational Site Number : 3920015	Kumagaya-shi
Japan	Investigational Site Number : 3920004	Kyoto-shi
Japan	Investigational Site Number : 3920012	Nagasaki-shi	Nagasaki
Japan	Investigational Site Number : 3920020	Nagoya-shi
Japan	Investigational Site Number : 3920008	Obu-shi
Japan	Investigational Site Number : 3920005	Osakasayama-shi
Japan	Investigational Site Number : 3920009	Sagamihara-shi	Kanagawa
Japan	Investigational Site Number : 3920014	Sendai-shi
Japan	Investigational Site Number : 3920019	Sendai-shi
Japan	Investigational Site Number : 3920001	Setagaya-ku	Tokyo
Japan	Investigational Site Number : 3920010	Tsu-shi
Japan	Investigational Site Number : 3920016	Yokohama-Shi	Kanagawa
Korea, Republic of	Investigational Site Number : 4100008	Ansan-si	Gyeonggi-do
Korea, Republic of	Investigational Site Number : 4100001	Gumi-city	Gyeongsangbuk-do
Korea, Republic of	Investigational Site Number : 4100007	Incheon	Gyeonggi-do
Korea, Republic of	Investigational Site Number : 4100003	Seoul
Korea, Republic of	Investigational Site Number : 4100004	Seoul
Korea, Republic of	Investigational Site Number : 4100005	Seoul
Korea, Republic of	Investigational Site Number : 4100002	Suwon	Gyeonggi-do
Mexico	Investigational Site Number : 4840001	Mexico
Mexico	Investigational Site Number : 4840006	Mexico
Mexico	Investigational Site Number : 4840003	Monterrey	Nuevo León
Mexico	Investigational Site Number : 4840004	Puebla
Mexico	Investigational Site Number : 4840005	Tlalnepantla
Netherlands	Investigational Site Number : 5280001	Amsterdam
Netherlands	Investigational Site Number : 5280006	Den Haag
Netherlands	Investigational Site Number : 5280005	Groningen
Netherlands	Investigational Site Number : 5280002	Rotterdam
Netherlands	Investigational Site Number : 5280003	Utrecht
Norway	Investigational Site Number : 5780001	Bergen
Norway	Investigational Site Number : 5780002	Oslo
Portugal	Investigational Site Number : 6200003	Braga
Portugal	Investigational Site Number : 6200001	Lisboa
Portugal	Investigational Site Number : 6200005	Lisboa
Russian Federation	Investigational Site Number : 6430001	Moscow
Russian Federation	Investigational Site Number : 6430002	Moscow
Russian Federation	Investigational Site Number : 6430003	Moscow
Russian Federation	Investigational Site Number : 6430004	Moscow
Russian Federation	Investigational Site Number : 6430005	Moscow
Spain	Investigational Site Number : 7240001	Alicante
Spain	Investigational Site Number : 7240002	Barcelona
Spain	Investigational Site Number : 7240005	Barcelona	Catalunya [Cataluña]
Spain	Investigational Site Number : 7240008	Comunidad Valenciana	Valencia
Spain	Investigational Site Number : 7240003	Madrid
Spain	Investigational Site Number : 7240009	Santullano De Mieres	Asturias
United States	Georgia Pollens Clinical Research Centers, Inc. Site Number : 8400057	Albany	Georgia
United States	Amarillo Center for Clinical Research Site Number : 8400055	Amarillo	Texas
United States	Orange County Research Institute Site Number : 8400028	Anaheim	California
United States	Allervie Clinical Research Site Number : 8400012	Birmingham	Alabama
United States	C Squared Research Center Site Number : 8400068	Birmingham	Alabama
United States	Cahaba Dermatology Site Number : 8400046	Birmingham	Alabama
United States	Daxia Trials Site Number : 8400082	Boca Raton	Florida
United States	Philip Fried, M.D., PLLC Site Number : 8400029	Bronx	New York
United States	Tiga Pediatrics, PC Site Number : 8400037	Bronx	New York
United States	Immunoe Research Centers Site Number : 8400026	Centennial	Colorado
United States	UNC Hospitals Site Number : 8400016	Chapel Hill	North Carolina
United States	MUSC Site Number : 8400013	Charleston	South Carolina
United States	Northwestern University Feinberg School of Medicine Site Number : 8400001	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center Site Number : 8400017	Cincinnati	Ohio
United States	Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400056	Columbus	Georgia
United States	Pediatric Center Of Excellence Site Number : 8400072	Coral Gables	Florida
United States	Green Dermatology and Cosmetic Center. Site Number : 8400078	Deerfield Beach	Florida
United States	2G Clinical Research Services Site Number : 8400031	Durham	North Carolina
United States	Clinical Research of Gastonia Site Number : 8400041	Gastonia	North Carolina
United States	Pediatric Dermatology of North Texas Site Number : 8400003	Grapevine	Texas
United States	Allergic Disease and Asthma Research Center, PA Site Number : 8400048	Greenville	South Carolina
United States	Cyn3rgy Research & Development Site Number : 8400023	Gresham	Oregon
United States	Amedica Research Institute, Inc. Site Number : 8400067	Hialeah	Florida
United States	Eastern Research, Inc. Site Number : 8400032	Hialeah	Florida
United States	Heights Dermatology and Aesthetic Center Site Number : 8400065	Houston	Texas
United States	Tokunbo T. Dada, MD PA Site Number : 8400079	Irvington	New Jersey
United States	Children's Mercy Hospital and Clinics Site Number : 8400020	Kansas City	Missouri
United States	Viable Research Management Site Number : 8400027	Las Vegas	Nevada
United States	Michael W. Simon, M.D., PSC Site Number : 8400073	Lexington	Kentucky
United States	Axis Clinical Trials Site Number : 8400025	Los Angeles	California
United States	Family Allergy and Asthma Research Site Number : 8400060	Louisville	Kentucky
United States	Madera Family Medical Group Site Number : 8400054	Madera	California
United States	Dermatology Associates of Mid-Ohio Site Number : 8400052	Marion	Ohio
United States	The Dermatology Institute of South Texas Site Number : 8400076	McAllen	Texas
United States	Ciocca, Giovanna Site Number : 8400018	Miami	Florida
United States	Premier Dermatology Partners Site Number : 8400075	Miami	Florida
United States	Vista Health Research, LLC Site Number : 8400034	Miami	Florida
United States	Medical College Of Wisconsin Site Number : 8400008	Milwaukee	Wisconsin
United States	C2 Research Center, LLC Site Number : 8400071	Montgomery	Alabama
United States	Family Pediatrics Iwuozo L Obilo Md Site Number : 8400077	Newark	New Jersey
United States	Providence Medical Center Site Number : 8400081	North Plainfield	New Jersey
United States	Pediatric & Adult Research Center Site Number : 8400040	Orlando	Florida
United States	Phoenix Children's Hospital, Inc. Site Number : 8400015	Phoenix	Arizona
United States	The Indiana Clinical Trials Center, PC Site Number : 8400007	Plainfield	Indiana
United States	AIM Trials Site Number : 8400035	Plano	Texas
United States	Dermatology Associates PC Site Number : 8400049	Rockville	Maryland
United States	NorthShore University HealthSystem Site Number : 8400064	Skokie	Illinois
United States	VAMA Medical Health Center Site Number : 8400083	Union	New Jersey
United States	Carey Chronis, MD, FAAP Site Number : 8400033	Ventura	California
United States	Michigan Dermatology Institute Site Number : 8400059	Waterford	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  China,  Colombia,  Denmark,  France,  Greece,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Portugal,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographics	Age, sex, race, ethnicity, body weight and height	Baseline
Primary	Age at AD onset	Age of study patients at time of AD onset	Baseline
Primary	Time from AD onset to initiation of therapy	Duration from onset of AD to start of AD therapy	Baseline
Primary	Type of current AD therapy	Type of therapy administered to treat AD (e.g., systemic, topical, other)	Baseline
Primary	Presence of AD and selected comorbid conditions	Percentage of patients with AD and selected comorbidities (e.g., asthma and allergic rhinitis) at baseline and during study	Baseline to Month 60
Secondary	Percentage of patients using specific AD therapies and initiating new therapies	Percentage of patients using specific AD therapies and initiating new therapies	Baseline to Month 60
Secondary	Eczema Area and Severity Index (EASI)	EASI score as assessed by physician	Baseline to Month 60
Secondary	Body Surface Area (BSA) percentage affected by AD	BSA score as assessed by physician	Baseline to Month 60
Secondary	Patient Oriented Eczema Measure (POEM) questionnaire	POEM score as reported by the participant's caregiver	Baseline to Month 60
Secondary	Children's Dermatology Life Quality Index (CDLQI)	CDLQI score as reported by the participant	Baseline to Month 60
Secondary	Infant's Dermatitis Quality of Life (IDQOL)	IDQOL score as reported by the participant's caregiver	Baseline to Month 60
Secondary	Dermatitis Family Impact (DFI) questionnaires	DFI score as reported by the participant's caregiver	Baseline to Month 60
Secondary	Peak Pruritus Numerical Rating Scale (NRS)	Peak Pruritus NRS score as reported by the participant	Baseline to Month 60
Secondary	Worst scratching NRS questionnaires	Worst scratching NRS score as reported by the participant's caregiver	Baseline to Month 60
Secondary	Caregiver Global Assessment of Disease (CGAD) questionnaire	CGAD score as reported by the participant's caregiver	Baseline to Month 60
Secondary	Total Nasal Symptom Score (TNSS) questionnaire	TNSS score as reported by the participant's caregiver	Baseline to Month 60
Secondary	Days missed from school for the patient and days missed from work for the primary caregiver due to AD	Days missed from school for the patient and days missed from work for the primary caregiver due to AD	Baseline to Month 60
Secondary	Number of visits to healthcare professionals	Number of visits to healthcare professionals for evaluation of healthcare utilization	Baseline to Month 60
Secondary	Incidence of adverse events	Frequency of patients with at least one event, the number of events, and the incidence rate will be summarized by System Organ Class and Preferred Term	Baseline to Month 60