Clinical trial NCT03687359: Observational Evaluation of Atopic Dermatitis in Pediatric Patients
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dermatitis Atopic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-09-27
Enrollment: 1845
Sex: ALL
Minimum age (years): 0
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients with moderate to severe AD whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable.

Brief 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.

Detailed description: The study duration is 120 months.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient demographics
timeFrame: Baseline (Month 0)
measure: Medical history of selected atopic diseases and comorbidities
timeFrame: Baseline (Month 0)
measure: Age at onset of atopic dermatitis (AD)
timeFrame: Baseline (Month 0)
measure: Personal and family history of AD and selected atopic diseases
timeFrame: Baseline (Month 0)
measure: All prior and current systemic AD treatment
timeFrame: Baseline (Month 0)
measure: All prior and current topical therapy and phototherapy for AD (including dose, route and frequency of administration for all AD treatment)
timeFrame: Baseline (Month 0)
measure: Presence/severity of AD and selected atopic comorbid conditions
timeFrame: Baseline to Month 120
measure: Therapy for selected atopic comorbid conditions
timeFrame: Baseline to Month 120
Secondary outcomes:
measure: Days missed from school for the patient and days missed from work for the primary caregiver due to AD
timeFrame: Baseline to Month 120
measure: Visits to healthcare professionals (HCPs)
timeFrame: Baseline to Month 120
measure: Treatments and prescribing patterns for pediatric AD
timeFrame: Baseline to Month 120
measure: Changes in physician assessment of disease burden (Eczema Area and Severity Index [EASI])
timeFrame: Baseline to Month 120
measure: Changes in physician assessment of disease burden (Body Surface Area [BSA])
timeFrame: Baseline to Month 120
measure: Changes in patient/caregiver-reported outcome (PRO): Patient-Oriented Eczema Measure (POEM)
timeFrame: Baseline to Month 120
measure: Change in PRO: Children's Dermatology Life Quality Index (CDLQI)/ Infant's Dermatitis Quality of Life (IDQOL)
timeFrame: Baseline to Month 120
measure: Change in PRO: Dermatitis Family Impact (DFI)
timeFrame: Baseline to Month 120
measure: Change in PRO: Peak Pruritus Numerical Rating Scale (NRS)/ Pruritus (Itch) NRS/ Worst scratching NRS
timeFrame: Baseline to Month 120
measure: Change in PRO: Caregiver Global Assessment of Disease (CGAD)
timeFrame: Baseline to Month 120
measure: Change in PRO: Days missed from school for the patient and days missed from work for the primary caregiver due to AD since last visit
timeFrame: Baseline to Month 120
measure: Change in PRO: Total Nasal Symptom Score (TNSS)
timeFrame: Baseline to Month 120
measure: Change in PRO: Pediatric Asthma Questionnaire (PAQ)
timeFrame: Baseline to Month 120
measure: Change in PRO: Juniper Asthma Control Questionnaire-5 (ACQ-5)
timeFrame: Baseline to Month 120
measure: Adverse event (AE) reporting
timeFrame: Baseline to Month 120
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: C Squared Research Center- Site Number : 8400068
state: Alabama
city: Birmingham
country: United States
facility: Cahaba Dermatology & Skin Health Center- Site Number : 8400046
state: Alabama
city: Montgomery
country: United States
facility: C2 Research Center, LLC- Site Number : 8400071
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Children's Hospital, Inc.- Site Number : 8400015
state: Arizona
city: Anaheim
country: United States
facility: Orange County Research Institute- Site Number : 8400028
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials- Site Number : 8400025
state: California
city: Madera
country: United States
facility: Madera Family Medical Group- Site Number : 8400054
state: California
city: Ventura
country: United States
facility: Carey Chronis, MD, FAAP- Site Number : 8400033
state: California
city: Boca Raton
country: United States
facility: Daxia Trials- Site Number : 8400082
state: Florida
city: Boca Raton
country: United States
facility: Frieder Dermatology- Site Number : 8400085
state: Florida
city: Coral Gables
country: United States
facility: Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology- Site Number : 8400072
state: Florida
city: Deerfield Beach
country: United States
facility: Green Dermatology and Cosmetic Center. Site Number : 8400078
state: Florida
city: Hialeah
country: United States
facility: Amedica Research Institute, Inc.- Site Number : 8400067
state: Florida
city: Hialeah
country: United States
facility: Eastern Research, Inc.- Site Number : 8400032
state: Florida
city: Miami
country: United States
facility: Premier Dermatology Partners- Site Number : 8400075
state: Florida
city: Miami
country: United States
facility: Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400074
state: Florida
city: Miami
country: United States
facility: Ciocca, Giovanna- Site Number : 8400018
state: Florida
city: Miami
country: United States
facility: Vista Health Research, LLC- Site Number : 8400034
state: Florida
city: Orlando
country: United States
facility: Pediatric & Adult Research Center- Site Number : 8400040
state: Florida
city: Pembroke Pines
country: United States
facility: Elias Dermatology LLC- Site Number : 8400086
state: Florida
city: Pembroke Pines
country: United States
facility: Elias Dermatology LLC- Site Number : 8400087
state: Florida
city: Columbus
country: United States
facility: Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400056
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine- Site Number : 8400001
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem - Skokie- Site Number : 8400064
state: Illinois
city: Plainfield
country: United States
facility: The Indiana Clinical Trial Center- Site Number : 8400007
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC Site Number : 8400007
state: Indiana
city: Lexington
country: United States
facility: Michael W. Simon, M.D., PSC- Site Number : 8400073
state: Kentucky
city: Rockville
country: United States
facility: Dermatology Associates PC- Site Number : 8400049
state: Maryland
city: Waterford
country: United States
facility: Michigan Dermatology Institute Site Number : 8400059
state: Michigan
city: Irvington
country: United States
facility: Tokunbo T. Dada, MD PA- Site Number : 8400079
state: New Jersey
city: Newark
country: United States
facility: Family Pediatrics Iwuozo L Obilo Md- Site Number : 8400077
state: New Jersey
city: North Plainfield
country: United States
facility: Providence Medical Center- Site Number : 8400081
state: New Jersey
city: Union
country: United States
facility: VAMA Medical Health Center- Site Number : 8400083
state: New Jersey
city: Bronx
country: United States
facility: Philip Fried, M.D., PLLC- Site Number : 8400029
state: New York
city: Bronx
country: United States
facility: Tiga Pediatrics, PC- Site Number : 8400037
state: New York
city: New York
country: United States
facility: Park Plaza Dermatology- Site Number : 8400080
state: New York
city: Chapel Hill
country: United States
facility: UNC Hospitals- Site Number : 8400016
state: North Carolina
city: Durham
country: United States
facility: 2G Clinical Research Services- Site Number : 8400031
state: North Carolina
city: Gastonia
country: United States
facility: Clinical Research Of Gastonia- Site Number : 8400041
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center- Site Number : 8400017
state: Ohio
city: Marion
country: United States
facility: Dermatology Associates of Mid-Ohio- Site Number : 8400052
state: Ohio
city: Charleston
country: United States
facility: MUSC- Site Number : 8400013
state: South Carolina
city: Greenville
country: United States
facility: ADAC Research- Site Number : 8400048
state: South Carolina
city: Amarillo
country: United States
facility: Amarillo Center for Clinical Research- Site Number : 8400055
state: Texas
city: Grapevine
country: United States
facility: ACRC Trials - Pediatric Dermatology of North Texas- Site Number : 8400003
state: Texas
city: Houston
country: United States
facility: Heights Dermatology & Aesthetic Center- Site Number : 8400065
state: Texas
city: McAllen
country: United States
facility: The Dermatology Institute of South Texas- Site Number : 8400076
state: Texas
city: Milwaukee
country: United States
facility: Medical College Of Wisconsin- Site Number : 8400008
state: Wisconsin
city: Bahía Blanca
country: Argentina
facility: Investigational Site Number : 0320009
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320003
state: Buenos Aires
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320004
state: Santa Fe
city: San Miguel de Tucumán
country: Argentina
facility: Investigational Site Number : 0320007
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320002
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320008
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320006
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320005
city: Cordoba
country: Argentina
facility: Investigational Site Number : 0320010
city: Salta
country: Argentina
facility: Investigational Site Number : 0320013
city: San Miguel de Tucuman
country: Argentina
facility: Investigational Site Number : 0320007
city: Kogarah
country: Australia
facility: Investigational Site Number : 0360008
state: New South Wales
city: Sydney
country: Australia
facility: Investigational Site Number : 0360011
state: New South Wales
city: Sydney
country: Australia
facility: Investigational Site Number : 0360009
state: New South Wales
city: Melbourne
country: Australia
facility: Investigational Site Number : 0360010
state: Victoria
city: Parkville
country: Australia
facility: Investigational Site Number : 0360003
state: Victoria
city: Richmond
country: Australia
facility: Investigational Site Number : 0360007
state: Victoria
city: Curitiba
country: Brazil
facility: Universidade Federal do Paraná- Site Number : 0760003
state: Paraná
city: Curitiba
country: Brazil
facility: Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760004
state: Paraná
city: Curitiba
country: Brazil
facility: Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760005
state: Paraná
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760002
state: Rio Grande Do Sul
city: Sorocaba
country: Brazil
facility: Clinica de Alergia Martti Antila- Site Number : 0760001
state: São Paulo
city: São Paulo
country: Brazil
facility: Hospital Sao Paulo- Site Number : 0760006
city: Calgary
country: Canada
facility: Investigational Site Number : 1240004
state: Alberta
city: Calgary
country: Canada
facility: Investigational Site Number : 1240007
state: Alberta
city: Winnipeg
country: Canada
facility: Investigational Site Number : 1240005
state: Manitoba
city: Halifax
country: Canada
facility: Investigational Site Number : 1240010
state: Nova Scotia
city: Markham
country: Canada
facility: Investigational Site Number : 1240001
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240008
state: Ontario
city: Montreal
country: Canada
facility: Investigational Site Number : 1240006
state: Quebec
city: Regina
country: Canada
facility: Investigational Site Number : 1240009
state: Saskatchewan
city: Beijing
country: China
facility: Investigational Site Number : 1560004
city: Changsha
country: China
facility: Investigational Site Number : 1560006
city: Chongqing
country: China
facility: Investigational Site Number : 1560001
city: Guangzhou
country: China
facility: Investigational Site Number : 1560012
city: Harbin
country: China
facility: Investigational Site Number : 1560007
city: Shanghai
country: China
facility: Investigational Site Number : 1560005
city: Shenzhen
country: China
facility: Investigational Site Number : 1560011
city: Suzhou
country: China
facility: Investigational Site Number : 1560002
city: Xuzhou
country: China
facility: Investigational Site Number : 1560008
city: Barranquilla
country: Colombia
facility: Investigational Site Number : 1700006
city: Bogota
country: Colombia
facility: Investigational Site Number : 1700001
city: Bogota
country: Colombia
facility: Investigational Site Number : 1700004
city: Kobenhavn Nv
country: Denmark
facility: Investigational Site Number : 2080002
city: Argenteuil Cedex
country: France
facility: Investigational Site Number : 2500008
city: Bordeaux
country: France
facility: Investigational Site Number : 2500001
city: Lille cedex
country: France
facility: Investigational Site Number : 2500010
city: Marseille cedex 5
country: France
facility: Investigational Site Number : 2500006
city: Martigues
country: France
facility: Investigational Site Number : 2500005
city: Nantes
country: France
facility: Investigational Site Number : 2500002
city: Paris cedex 15
country: France
facility: Investigational Site Number : 2500003
city: Toulouse Cedex 9
country: France
facility: Investigational Site Number : 2500011
city: Larissa
country: Greece
facility: Investigational Site Number : 3000004
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000005
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000003
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000002
city: Be'er Sheva
country: Israel
facility: Investigational Site Number : 3760003
city: Haifa
country: Israel
facility: Investigational Site Number : 3760004
city: Kefar Sava
country: Israel
facility: Investigational Site Number : 3760005
city: Ramat Gan
country: Israel
facility: Investigational Site Number : 3760001
city: Rehovot
country: Israel
facility: Investigational Site Number : 3760002
city: Terracina
country: Italy
facility: Investigational Site Number : 3800004
state: Latina
city: Padua
country: Italy
facility: Investigational Site Number : 3800011
state: Padova
city: Padua
country: Italy
facility: Investigational Site Number : 3800006
state: Veneto
city: Bari
country: Italy
facility: Investigational Site Number : 3800012
city: Bologna
country: Italy
facility: Investigational Site Number : 3800003
city: Brescia
country: Italy
facility: Investigational Site Number : 3800014
city: Caserta
country: Italy
facility: Investigational Site Number : 3800008
city: Catania
country: Italy
facility: Investigational Site Number : 3800010
city: Milano
country: Italy
facility: Investigational Site Number : 3800001
city: Napoli
country: Italy
facility: Investigational Site Number : 3800005
city: Perugia
country: Italy
facility: Investigational Site Number : 3800009
city: Reggio Emilia
country: Italy
facility: Investigational Site Number : 3800013
city: Roma
country: Italy
facility: Investigational Site Number : 3800018
city: Trieste
country: Italy
facility: Investigational Site Number : 3800007
city: Sagamihara
country: Japan
facility: Investigational Site Number : 3920009
state: Kanagawa
city: Yokohama
country: Japan
facility: Investigational Site Number : 3920016
state: Kanagawa
city: TSU
country: Japan
facility: Investigational Site Number : 3920010
state: Mie
city: Habikino
country: Japan
facility: Investigational Site Number : 3920003
state: Osaka
city: Fuchu
country: Japan
facility: Investigational Site Number : 3920011
state: Tokyo
city: Fukuoka-shi
country: Japan
facility: Investigational Site Number : 3920018
city: Fukuyama-shi
country: Japan
facility: Investigational Site Number : 3920017
city: Hiroshima
country: Japan
facility: Investigational Site Number : 3920002
city: Kumagaya-shi
country: Japan
facility: Investigational Site Number : 3920015
city: Kyoto
country: Japan
facility: Investigational Site Number : 3920004
city: Nagasaki
country: Japan
facility: Investigational Site Number : 3920012
city: Nagoya-shi
country: Japan
facility: Investigational Site Number : 3920020
city: Obu-shi
country: Japan
facility: Investigational Site Number : 3920008
city: Osakasayama-shi
country: Japan
facility: Investigational Site Number : 3920005
city: Sendai-shi
country: Japan
facility: Investigational Site Number : 3920014
city: Sendai-shi
country: Japan
facility: Investigational Site Number : 3920019
city: Tokyo
country: Japan
facility: Investigational Site Number : 3920001
city: Yokohama-shi
country: Japan
facility: Investigational Site Number : 3920016
city: Ansan-si
country: Korea, Republic of
facility: Investigational Site Number : 4100008
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Investigational Site Number : 4100002
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Investigational Site Number : 4100007
state: Incheon-gwangyeoksi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100001
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100003
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100005
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100004
city: Cuernavaca
country: Mexico
facility: Investigational Site Number : 4840010
state: Morelos
city: Monterrey
country: Mexico
facility: Investigational Site Number : 4840003
state: Nuevo León
city: Monterrey
country: Mexico
facility: Investigational Site Number : 4840009
state: Nuevo León
city: Monterrey
country: Mexico
facility: Investigational Site Number : 4840008
state: Nuevo León
city: Mexico
country: Mexico
facility: Investigational Site Number : 4840001
city: Mexico
country: Mexico
facility: Investigational Site Number : 4840006
city: Puebla
country: Mexico
facility: Investigational Site Number : 4840004
city: Tlalnepantla de Baz
country: Mexico
facility: Investigational Site Number : 4840005
city: Amsterdam
country: Netherlands
facility: Investigational Site Number : 5280001
city: Den Haag
country: Netherlands
facility: Investigational Site Number : 5280006
city: Groningen
country: Netherlands
facility: Investigational Site Number : 5280005
city: Rotterdam
country: Netherlands
facility: Investigational Site Number : 5280002
city: Utrecht
country: Netherlands
facility: Investigational Site Number : 5280003
city: Bergen
country: Norway
facility: Investigational Site Number : 5780001
city: Oslo
country: Norway
facility: Investigational Site Number : 5780002
city: Stavanger
country: Norway
facility: Investigational Site Number : 5780003
city: Braga
country: Portugal
facility: Investigational Site Number : 6200003
city: Lisboa
country: Portugal
facility: Investigational Site Number : 6200005
city: Lisboa
country: Portugal
facility: Investigational Site Number : 6200001
city: Porto
country: Portugal
facility: Investigational Site Number : 6200006
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430005
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430002
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430003
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430001
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430004
city: Mieres
country: Spain
facility: Investigational Site Number : 7240009
state: Asturias
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240005
state: Catalunya [Cataluña]
city: Pozuelo de Alarcón
country: Spain
facility: Investigational Site Number : 7240012
state: Madrid
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240011
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240002
city: Madrid
country: Spain
facility: Investigational Site Number : 7240003
city: Madrid
country: Spain
facility: Investigational Site Number : 7240010
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Paller AS, Guttman-Yassky E, Irvine AD, Baselga E, de Bruin-Weller M, Jayawardena S, Zhang A, Mina-Osorio P, Rizova E, Ozturk ZE. Protocol for a prospective, observational, longitudinal study in paediatric patients with moderate-to-severe atopic dermatitis (PEDISTAD): study objectives, design and methodology. BMJ Open. 2020 Mar 24;10(3):e033507. doi: 10.1136/bmjopen-2019-033507.