Clinical trial NCT03849716: Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients (PEDISTAD BIOMARKER STUDY)
Official title: Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dermatitis Atopic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2019-02-21
Enrollment: 266
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: NON_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, who are included in observational study OBS15333 and consent to enter this companion study LPS15496.

Brief summary: Primary Objective:

To explore associations between biomarkers of atopic dermatitis (AD) and:

* Disease state and time course of AD,
* Disease state and evolution of selected atopic comorbid conditions,
* Effectiveness of specific AD treatments.

Detailed description: The estimated enrollment duration is approximately 2 years, while duration of observation is approximately 5 years.

Eligibility criteria: Inclusion criteria:

* Participation in the OBS15333 pediatric atopic dermatitis (AD) registry.
* Signed informed consent by the parent/legally acceptable representative and assent by the participant appropriate to the participant's age.

Exclusion criteria:

Not applicable.

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

Primary outcomes:
measure: Biomarker identification: Demographics
timeFrame: Baseline
measure: Biomarker identification: Baseline disease characteristics
timeFrame: Baseline
measure: Biomarker identification: Changes in disease severity
timeFrame: Up to 5 years
measure: Biomarker evaluation: High versus low disease severity across participants
timeFrame: Up to 5 years
measure: Biomarker identification: New presentation or resolution of atopic comorbidity
timeFrame: Up to 5 years
measure: Biomarker identification: Introduction of new systemic treatment
timeFrame: Up to 5 years
measure: Biomarker identification: Response to systemic treatment
timeFrame: Up to 5 years
measure: Biomarker identification: Loss of response to systemic treatment
timeFrame: Up to 5 years
measure: Biomarker evaluation: Start of systemic therapy early in life versus later in life
timeFrame: Up to 5 years
Secondary outcomes:
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 Site Number : 8400046
state: Alabama
city: Montgomery
country: United States
facility: C2 Research Center, LLC Site Number : 8400071
state: Alabama
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: Oxnard
country: United States
facility: Fomat Medical Research, Inc. Site Number : 8400033
state: California
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: 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: Albany
country: United States
facility: Georgia Pollens Clinical Research Centers, Inc. Site Number : 8400057
state: Georgia
city: Columbus
country: United States
facility: IACT Health 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 Site Number : 8400064
state: Illinois
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: 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: Allergic Disease and Asthma Research Center, PA Site Number : 8400048
state: South Carolina
city: Amarillo
country: United States
facility: Amarillo Center for Clinical Research Site Number : 8400055
state: Texas
city: Houston
country: United States
facility: Heights Dermatology and Aesthetic Center Site Number : 8400065
state: Texas
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320002
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Investigational Site Number : 0320006
state: Buenos Aires
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320004
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320003
city: Ciudad Autonoma Bs As
country: Argentina
facility: Investigational Site Number : 0320001
city: Westmead
country: Australia
facility: Investigational Site Number : 0360001
state: New South Wales
city: Melbourne
country: Australia
facility: Investigational Site Number : 0360003
state: Victoria
city: Curitiba
country: Brazil
facility: Universidade Federal do Paraná Site Number : 0760003
state: Paraná
city: Curitiba
country: Brazil
facility: HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760004
state: Paraná
city: Curitiba
country: Brazil
facility: HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná 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: SÃ£o Paulo
country: Brazil
facility: Hospital Sao Paulo Site Number : 0760006
state: São Paulo
city: Sorocaba
country: Brazil
facility: Clínica de Alergia Martti Antila Site Number : 0760001
city: Calgary
country: Canada
facility: Investigational Site Number : 1240007
state: Alberta
city: Winnipeg
country: Canada
facility: Investigational Site Number : 1240005
state: Manitoba
city: Toronto
country: Canada
facility: Investigational Site Number : 1240008
state: Ontario
city: Montreal
country: Canada
facility: Investigational Site Number : 1240006
state: Quebec
city: Bogota
country: Colombia
facility: Investigational Site Number : 1700001
city: Bogota
country: Colombia
facility: Investigational Site Number : 1700004
city: Marseille cedex 5
country: France
facility: Investigational Site Number : 2500006
city: Paris Cedex 15
country: France
facility: Investigational Site Number : 2500003
city: Monterrey
country: Mexico
facility: Investigational Site Number : 4840003
state: Nuevo León
city: Mexico
country: Mexico
facility: Investigational Site Number : 4840006
city: Tlalnepantla
country: Mexico
facility: Investigational Site Number : 4840005
city: Groningen
country: Netherlands
facility: Investigational Site Number : 5280005
city: Utrecht
country: Netherlands
facility: Investigational Site Number : 5280003
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: