Observational Evaluation of Atopic Dermatitis in Pediatric Patients (PEDISTAD)

• ClinicalTrials.gov Identifier: NCT03687359
• Recruitment Status: Recruiting
• First Posted: September 27, 2018
• Last Update Posted: December 15, 2023
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Tracking Information

• First Submitted Date: September 6, 2018
• First Posted Date: September 27, 2018
• Last Update Posted Date: December 15, 2023
• Actual Study Start Date: August 15, 2019
• Estimated Primary Completion Date: April 21, 2036 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 25, 2018)

• Demographics [ Time Frame: Baseline ]
  Age, sex, race, ethnicity, body weight and height
• Age at AD onset [ Time Frame: Baseline ]
  Age of study patients at time of AD onset
• Time from AD onset to initiation of therapy [ Time Frame: Baseline ]
  Duration from onset of AD to start of AD therapy
• Type of current AD therapy [ Time Frame: Baseline ]
  Type of therapy administered to treat AD (e.g., systemic, topical, other)
• Presence of AD and selected comorbid conditions [ Time Frame: Baseline to Month 60 ]
  Percentage of patients with AD and selected comorbidities (e.g., asthma and allergic rhinitis) at baseline and during study

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 25, 2018)

• Percentage of patients using specific AD therapies and initiating new therapies [ Time Frame: Baseline to Month 60 ]
  Percentage of patients using specific AD therapies and initiating new therapies
• Eczema Area and Severity Index (EASI) [ Time Frame: Baseline to Month 60 ]
  EASI score as assessed by physician
• Body Surface Area (BSA) percentage affected by AD [ Time Frame: Baseline to Month 60 ]
  BSA score as assessed by physician
• Patient Oriented Eczema Measure (POEM) questionnaire [ Time Frame: Baseline to Month 60 ]
  POEM score as reported by the participant's caregiver
• Children's Dermatology Life Quality Index (CDLQI) [ Time Frame: Baseline to Month 60 ]
  CDLQI score as reported by the participant
• Infant's Dermatitis Quality of Life (IDQOL) [ Time Frame: Baseline to Month 60 ]
  IDQOL score as reported by the participant's caregiver
• Dermatitis Family Impact (DFI) questionnaires [ Time Frame: Baseline to Month 60 ]
  DFI score as reported by the participant's caregiver
• Peak Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline to Month 60 ]
  Peak Pruritus NRS score as reported by the participant
• Worst scratching NRS questionnaires [ Time Frame: Baseline to Month 60 ]
  Worst scratching NRS score as reported by the participant's caregiver
• Caregiver Global Assessment of Disease (CGAD) questionnaire [ Time Frame: Baseline to Month 60 ]
  CGAD score as reported by the participant's caregiver
• Total Nasal Symptom Score (TNSS) questionnaire [ Time Frame: Baseline to Month 60 ]
  TNSS score as reported by the participant's caregiver
• Days missed from school for the patient and days missed from work for the primary caregiver due to AD [ Time Frame: Baseline to Month 60 ]
  Days missed from school for the patient and days missed from work for the primary caregiver due to AD
• Number of visits to healthcare professionals [ Time Frame: Baseline to Month 60 ]
  Number of visits to healthcare professionals for evaluation of healthcare utilization
• Incidence of adverse events [ Time Frame: Baseline to Month 60 ]
  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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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 60 months.
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Biospecimen: Not Provided
• 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.
• Condition: Dermatitis Atopic

Intervention

Other: Standard of care

Treatment as per standard practice

Study Groups/Cohorts

Participants with atopic dermatitis (AD)

Participants receive AD therapy as part of their usual care as determined by their physician independent of decision to enroll in the study.

Intervention: Other: Standard of care

• Publications *: 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 8, 2023): 1856
• Original Estimated Enrollment (submitted: September 25, 2018): 1300
• Estimated Study Completion Date: April 21, 2036
• Estimated Primary Completion Date: April 21, 2036 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 0 Years to 11 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: Trial Transparency email recommended (Toll free number for US & Canada); 800-633-1610 ext 1 then #; Contact-US@sanofi.com

• Listed Location Countries: Argentina, Australia, Brazil, Canada, China, Colombia, Denmark, France, Greece, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Portugal, Russian Federation, Spain, United States
• Removed Location Countries: Belgium

Administrative Information

• NCT Number: NCT03687359
• Other Study ID Numbers: OBS15333; U1111-1211-9437 ( Registry Identifier: ICTRP )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Sanofi
• Original Responsible Party: Same as current
• Current Study Sponsor: Sanofi
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

• PRS Account: Sanofi
• Verification Date: December 2023