Observational Evaluation of Atopic Dermatitis in Pediatric Patients (PEDISTAD)
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| ClinicalTrials.gov Identifier: NCT03687359 |
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Recruitment Status :
Active, not recruiting
First Posted : September 27, 2018
Last Update Posted : May 1, 2023
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Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
- Study Details
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- No Results Posted
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Dermatitis Atopic | Other: Standard of care |
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 1228 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 5 Years |
| 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 |
| Actual Study Start Date : | August 15, 2019 |
| Estimated Primary Completion Date : | March 14, 2036 |
| Estimated Study Completion Date : | March 14, 2036 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Atopic dermatitis
MedlinePlus related topics:
Eczema
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Other: Standard of care
Treatment as per standard practice |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 0 Years to 11 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687359
Locations
Show 21 study locations
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT03687359 |
| Other Study ID Numbers: |
OBS15333 U1111-1211-9437 ( Other Identifier: UTN ) |
| First Posted: | September 27, 2018 Key Record Dates |
| Last Update Posted: | May 1, 2023 |
| Last Verified: | April 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
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Dermatitis, Atopic Dermatitis Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn |
Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |