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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05081557
Registration number
NCT05081557
Ethics application status
Date submitted
7/10/2021
Date registered
18/10/2021
Date last updated
4/06/2024
Titles & IDs
Public title
A Study to Assess Real-World Use, Safety, and Effectiveness of Oral Upadacitinib in Adult and Adolescent (>=12 Years Old) Participants With Atopic Dermatitis
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Scientific title
Real World Utilization of Upadacitinib in Adult and Adolescent Patients Living With Moderate to Severe Atopic Dermatitis (AD-VISE)
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Secondary ID [1]
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P20-441
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Universal Trial Number (UTN)
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Trial acronym
AD-VISE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
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Condition category
Condition code
Skin
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0
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Dermatological conditions
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Skin
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0
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0
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Other skin conditions
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Inflammatory and Immune System
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0
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Participants Receiving Upadacitinib - Participants receiving upadacitinib for atopic dermatitis.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Upadacitinib (UPA) Utilization Patterns
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Assessment method [1]
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UPA utilization patterns will be achieved by (i) providing descriptive statistics of patient demographics and disease characteristics for patients who starting UPA 15 mg at baseline and patients who starting UPA 30 mg at baseline, respectively; (ii) calculating number and proportion of patients with different UPA and concomitant therapy changes throughout the observation period, and the rationale for any changes.
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Timepoint [1]
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Up to Approximately 24 Months
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Primary outcome [2]
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Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) 0/1
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Assessment method [2]
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vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.
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Timepoint [2]
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Month 4
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Primary outcome [3]
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vIGA-AD 0/1 Among Participants Who Achieved vIGA-AD 0/1 at Month 4
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Assessment method [3]
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vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.
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Timepoint [3]
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Month 24
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Secondary outcome [1]
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Modification of UPA or Concomitant AD Therapy and Associated Timing, Reasons
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Assessment method [1]
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This includes UPA dose change, temporary or permanent discontinuation, switching, add or remove TCS.
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Timepoint [1]
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Month 24
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Secondary outcome [2]
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Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75
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Assessment method [2]
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The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).
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Timepoint [2]
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Up to Approximately 24 months
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Secondary outcome [3]
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Percentage of Participants Achieving EASI 90
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Assessment method [3]
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0
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).
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Timepoint [3]
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Up to Approximately 24 Months
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Secondary outcome [4]
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Percentage of Participants Achieving EASI 100
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Assessment method [4]
0
0
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).
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Timepoint [4]
0
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Up to Approximately 24 Months
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Secondary outcome [5]
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Percentage of Participants Achieving EASI <=1
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Assessment method [5]
0
0
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).
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Timepoint [5]
0
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Up to Approximately 24 Months
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Secondary outcome [6]
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Percentage of Participants Achieving EASI <=5.9
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Assessment method [6]
0
0
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).
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Timepoint [6]
0
0
Up to Approximately 24 Months
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Secondary outcome [7]
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0
Percentage of Participants Achieving EASI <=7
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Assessment method [7]
0
0
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).
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Timepoint [7]
0
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Up to Approximately 24 Months
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Secondary outcome [8]
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Percentage of Participants Achieving vIGA-AD 0/1
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Assessment method [8]
0
0
vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.
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Timepoint [8]
0
0
Up to Approximately 24 Months (Excluding Month 4 - Primary Outcome)
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Secondary outcome [9]
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0
Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) 0/1
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Assessment method [9]
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Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
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Timepoint [9]
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0
Up to Approximately 24 Months
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Secondary outcome [10]
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Percentage of Participants Achieving WP-NRS <=3
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Assessment method [10]
0
0
WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
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Timepoint [10]
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0
Up to Approximately 24 Months
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Secondary outcome [11]
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Percentage of Participants Achieving WP-NRS reduction >=4
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Assessment method [11]
0
0
WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
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Timepoint [11]
0
0
Up to Approximately 24 Months
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Secondary outcome [12]
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0
Percentage of Participants Achieving Patient Oriented Eczema Measurement (POEM) Score <=2
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Assessment method [12]
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0
The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID.
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Timepoint [12]
0
0
Up to Approximately 24 Months
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Secondary outcome [13]
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0
Percentage of Participants Achieving POEM <=7
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Assessment method [13]
0
0
The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID
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Timepoint [13]
0
0
Up to Approximately 24 Months
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Secondary outcome [14]
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0
Percentage of Participants Achieving POEM Reduction >=4
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Assessment method [14]
0
0
The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID
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Timepoint [14]
0
0
Up to Approximately 24 Months
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Secondary outcome [15]
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Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0/1
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Assessment method [15]
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0
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
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Timepoint [15]
0
0
Up to Approximately 24 Months
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Secondary outcome [16]
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Percentage of Participants Achieving DLQI Score <=5
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Assessment method [16]
0
0
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
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Timepoint [16]
0
0
Up to Approximately 24 Months
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Secondary outcome [17]
0
0
Percentage of Participants Achieving DLQI reduction >=4
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Assessment method [17]
0
0
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
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Timepoint [17]
0
0
Up to Approximately 24 Months
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Secondary outcome [18]
0
0
Percentage of Participants Achieving Atopic Dermatitis Control Tool (ADCT) <7 (control)
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Assessment method [18]
0
0
The ADCT is a validated patient self-administered instrument designed to assess AD control status in adult and adolescent patients (12 years and older). Six AD symptoms and impacts are evaluated over the past week including overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep, impact on daily activities, and impact on mood or emotions. Each item is scored 0-4. The sum of the 6 item scores form the ADCT total score (range 0-24). A higher score indicates lower AD control. A score of =7 indicates that the patient is not in control. The threshold for meaningful within-person change is estimated to be 5 points.
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Timepoint [18]
0
0
Up to Approximately 24 Months
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Secondary outcome [19]
0
0
Percentage of Participants Achieving ADCT reduction >=5
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Assessment method [19]
0
0
The ADCT is a validated patient self-administered instrument designed to assess AD control status in adult and adolescent patients (12 years and older). Six AD symptoms and impacts are evaluated over the past week including overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep, impact on daily activities, and impact on mood or emotions. Each item is scored 0-4. The sum of the 6 item scores form the ADCT total score (range 0-24). A higher score indicates lower AD control. A score of =7 indicates that the patient is not in control. The threshold for meaningful within-person change is estimated to be 5 points.
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Timepoint [19]
0
0
Up to approximately 24 Months
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Secondary outcome [20]
0
0
Percentage of Participants who are "Extremely Satisfied" or "Very Satisfied" with their AD Treatment using the Patient Global Impression of Treatment for Atopic Dermatitis (PGIT-AD)
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Assessment method [20]
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0
PGIT-AD is a single item patient self-administered instrument designed to assess patient satisfaction or dissatisfaction with their current treatment for atopic dermatitis based on the following question: "Overall, how satisfied or dissatisfied are you with your current treatment for atopic dermatitis?". Response options range from 1 (extremely dissatisfied) to 7 (extremely satisfied).
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Timepoint [20]
0
0
Up to Approximately 24 Months
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Secondary outcome [21]
0
0
Percentage of Participants Remaining on Upadacitinib Once Daily
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Assessment method [21]
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0
Percentage of participants remaining on upadacitinib once daily at all applicable time points.
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Timepoint [21]
0
0
Up to Approximately 24 Months
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Secondary outcome [22]
0
0
Percentage of Participants Achieving EASI 75 Among Participants Who Achieved EASI 75 at Month 4
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Assessment method [22]
0
0
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).
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Timepoint [22]
0
0
Up to Approximately 24 months
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Secondary outcome [23]
0
0
Percentage of Participants Achieving EASI 90 Among Participants Who Achieved EASI 90 at Month 4
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Assessment method [23]
0
0
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).
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Timepoint [23]
0
0
Up to Approximately 24 months
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Secondary outcome [24]
0
0
Percentage of Participants Achieving EASI 100 Among Participants Who Achieved EASI 100 at Month 4
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Assessment method [24]
0
0
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).
Query!
Timepoint [24]
0
0
Up to Approximately 24 months
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Secondary outcome [25]
0
0
Percentage of Participants Achieving vIGA-AD 0/1 Among Participants Who Achieved vIGA-AD at Month 4
Query!
Assessment method [25]
0
0
vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.
Query!
Timepoint [25]
0
0
Up to Approximately 24 Months (Excluding Month 24 - Primary Outcome)
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Secondary outcome [26]
0
0
Percentage of Participants Achieving WP-NRS 0/1 Among Participants Who Achieved WP-NRS 0/1 at Month 4
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Assessment method [26]
0
0
WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
Query!
Timepoint [26]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [27]
0
0
Percentage of Participants Achieving DLQI Score of 0/1 Among Participants Achieving DLQI Score of 0/1 at Month 4
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Assessment method [27]
0
0
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
Query!
Timepoint [27]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [28]
0
0
Percentage of Participants Achieving ADCT Reduction <7 Among Participants Who Achieved ADCT Reduction <7 at Month 4
Query!
Assessment method [28]
0
0
The ADCT is a validated patient self-administered instrument designed to assess AD control status in adult and adolescent patients (12 years and older). Six AD symptoms and impacts are evaluated over the past week including overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep, impact on daily activities, and impact on mood or emotions. Each item is scored 0-4. The sum of the 6 item scores form the ADCT total score (range 0-24). A higher score indicates lower AD control. A score of =7 indicates that the patient is not in control. The threshold for meaningful within-person change is estimated to be 5 points.
Query!
Timepoint [28]
0
0
Up to approximately 24 Months
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Secondary outcome [29]
0
0
Absolute Score and Change from Baseline in EASI
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Assessment method [29]
0
0
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).
Query!
Timepoint [29]
0
0
Up to Approximately 24 months
Query!
Secondary outcome [30]
0
0
Absolute Score and Change from Baseline in vIGA-AD
Query!
Assessment method [30]
0
0
vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.
Query!
Timepoint [30]
0
0
Up to Approximately 24 months
Query!
Secondary outcome [31]
0
0
Absolute Score and Change from Baseline in Body Surface Area (BSA)
Query!
Assessment method [31]
0
0
The investigator selects the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus five digits is assumed to be approximately equivalent to 1%. Measurement of the total area of involvement by the investigator is aided by imagining if scattered plaques were moved so that they were next to each other and then estimating the total area involved. Published score bands: 0% (clear), 0.1-15.9% (mild), 16.0-39.9% (moderate), 40-100% (severe).
Query!
Timepoint [31]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [32]
0
0
Absolute Score and Change from Baseline in WP-NRS
Query!
Assessment method [32]
0
0
WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
Query!
Timepoint [32]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [33]
0
0
Absolute Score and Change from Baseline in POEM
Query!
Assessment method [33]
0
0
The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID.
Query!
Timepoint [33]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [34]
0
0
Absolute Score and Change from Baseline in DLQI
Query!
Assessment method [34]
0
0
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
Query!
Timepoint [34]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [35]
0
0
Absolute Score and Change from Baseline in ADCT
Query!
Assessment method [35]
0
0
The ADCT is a validated patient self-administered instrument designed to assess AD control status in adult and adolescent patients (12 years and older). Six AD symptoms and impacts are evaluated over the past week including overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep, impact on daily activities, and impact on mood or emotions. Each item is scored 0-4. The sum of the 6 item scores form the ADCT total score (range 0-24). A higher score indicates lower AD control. A score of =7 indicates that the patient is not in control. The threshold for meaningful within-person change is estimated to be 5 points.
Query!
Timepoint [35]
0
0
Up to Approximately 24 months
Query!
Secondary outcome [36]
0
0
Absolute Score and Change from Baseline in PGIT-AD
Query!
Assessment method [36]
0
0
PGIT-AD is a single item patient self-administered instrument designed to assess patient satisfaction or dissatisfaction with their current treatment for atopic dermatitis based on the following question: "Overall, how satisfied or dissatisfied are you with your current treatment for atopic dermatitis?". Response options range from 1 (extremely dissatisfied) to 7 (extremely satisfied).
Query!
Timepoint [36]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [37]
0
0
Change from Baseline in Flare Frequency and Duration
Query!
Assessment method [37]
0
0
Participants are asked to provide the number of flares in the previous 6 months, and the average duration of flares in the previous 6 months. Participants are asked if currently experiencing an atopic dermatitis flare. Flare is defined as a sudden worsening of AD requiring treatment escalation and/or additional medical advice.
Query!
Timepoint [37]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [38]
0
0
Change from Baseline in the Number of AD-Related Physician Office or Hospital Visits
Query!
Assessment method [38]
0
0
Participants are asked the number of AD-related physician office visits in the previous 6 months and the number of AD-related hospital visits in the previous 6 months.
Query!
Timepoint [38]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [39]
0
0
Absolute Score and Change from Baseline in Work Productivity and Activity Impairment Index for Atopic Dermatitis (WPAI-AD)
Query!
Assessment method [39]
0
0
The Work Productivity and Activity Impairment Index for Atopic Dermatitis (WPAI-AD) is a validated instrument used to measure loss of productivity at work and impairment in daily activities over the past 7 days. The questionnaire includes four items: absenteeism, presenteeism, overall work impairment, and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment. While absenteeism represents the percentage of work time missed due to AD, presenteeism represents the percentage of impairment while at work due to AD. Overall work impairment represents the total percentage of work time missed due to either absenteeism or presenteeism (since those are mutually exclusive). Activity impairment represents the percentage of impairment during daily activities other than work. The 4 items are all evaluated using an 11-point Likert-type scale from 0 (no effect) to 10 (completely prevented), and the scores are multiplied by ten to arrive at a percentage.
Query!
Timepoint [39]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [40]
0
0
Time to Achieve EASI 75
Query!
Assessment method [40]
0
0
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).
Query!
Timepoint [40]
0
0
Up to Approximately 24 months
Query!
Secondary outcome [41]
0
0
Time to Achieve EASI 90
Query!
Assessment method [41]
0
0
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).
Query!
Timepoint [41]
0
0
Up to Approximately 24 months
Query!
Secondary outcome [42]
0
0
Time to Achieve EASI 100
Query!
Assessment method [42]
0
0
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).
Query!
Timepoint [42]
0
0
Up to Approximately 24 months
Query!
Secondary outcome [43]
0
0
Time to Achieve vIGA-AD 0/1
Query!
Assessment method [43]
0
0
vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.
Query!
Timepoint [43]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [44]
0
0
Time to Achieve WP-NRS 0/1
Query!
Assessment method [44]
0
0
WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
Query!
Timepoint [44]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [45]
0
0
Time to Achieve DLQI Score of 0/1
Query!
Assessment method [45]
0
0
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
Query!
Timepoint [45]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [46]
0
0
Time to Achieve POEM <=2
Query!
Assessment method [46]
0
0
The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in both children and adults. Subjects respond to 7 items, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency over the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores (0 to 4) are added to provide a total score range of 0 to 28. The total score reflects disease-related morbidity, and differentiates between "clear/almost clear" (0-2 points), "mild" (3-7 points), "moderate" (8-16 points), "severe" (17-24 points) and "very severe" (25-28 points) AD. A change in POEM score of 3.4 points is considered the MCID.
Query!
Timepoint [46]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [47]
0
0
Time to Achieve ADCT <7
Query!
Assessment method [47]
0
0
The ADCT is a validated patient self-administered instrument designed to assess AD control status in adult and adolescent patients (12 years and older). Six AD symptoms and impacts are evaluated over the past week including overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep, impact on daily activities, and impact on mood or emotions. Each item is scored 0-4. The sum of the 6 item scores form the ADCT total score (range 0-24). A higher score indicates lower AD control. A score of =7 indicates that the patient is not in control. The threshold for meaningful within-person change is estimated to be 5 points.
Query!
Timepoint [47]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [48]
0
0
Time-Weighted EASI Score
Query!
Assessment method [48]
0
0
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).
Query!
Timepoint [48]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [49]
0
0
Time-Weighted vIGA-AD Score
Query!
Assessment method [49]
0
0
vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.
Query!
Timepoint [49]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [50]
0
0
Time-Weighted WP-NRS Score
Query!
Assessment method [50]
0
0
WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
Query!
Timepoint [50]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [51]
0
0
Time-Weighted DLQI Score
Query!
Assessment method [51]
0
0
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
Query!
Timepoint [51]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [52]
0
0
Percentage of Participants Achieving Treatment Target EASI <8
Query!
Assessment method [52]
0
0
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).
Query!
Timepoint [52]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [53]
0
0
Percentage of Participants Achieving Treatment Target DLQI <=5
Query!
Assessment method [53]
0
0
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
Query!
Timepoint [53]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [54]
0
0
Percentage of Participants Achieving Treatment Target WP-NRS <=4
Query!
Assessment method [54]
0
0
WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.
Query!
Timepoint [54]
0
0
Up to Approximately 24 Months
Query!
Secondary outcome [55]
0
0
Percentage of Participants Achieving Combined Treatment Targets of EASI <8, DLQI <=5, and WP-NRS <=4
Query!
Assessment method [55]
0
0
EASI is a validated measure used to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). DLQI is a 10-item, validated questionnaire to assess the impact of AD disease symptoms and treatment on HRQoL. It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours.
Query!
Timepoint [55]
0
0
Up to Approximately 24 Months
Query!
Eligibility
Key inclusion criteria
- Physician confirmed diagnosis of atopic dermatitis (AD) or atopic eczema at baseline.
- Symptom onset >=1-year prior to baseline.
- Initiation of upadacitinib treatment for AD is indicated and prescribed per local
label.
- The decision to prescribe UPA is made prior to and independently of study
participation.
- Medical and medication history available for previous 6 months.
- Participants who can understand the questionnaires, with parental support as required
for adolescents.
- Participants who are able to understand and communicate with the investigator and
comply with the requirements of the study.
- Participants who are willing and able to participate in the collection of
patient-reported data via cloud-based mobile application using a smart device (i.e.,
tablet).
- Participants who are willing and able to complete the patient-reported questionnaires.
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Participants who are currently participating in interventional research (not including
non-interventional study, post-marketing observational study, or registry participation).
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
17/11/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
15/10/2026
Query!
Actual
Query!
Sample size
Target
975
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Kingsway Dermatology & Aesthetics /ID# 242276 - Miranda
Query!
Recruitment hospital [2]
0
0
Veracity Clinical Research /ID# 242275 - Woolloongabba
Query!
Recruitment hospital [3]
0
0
Flinders Medical Centre /ID# 242162 - Bedford, Park
Query!
Recruitment hospital [4]
0
0
Sinclair Dermatology - Melbourne /ID# 242163 - East Melbourne
Query!
Recruitment hospital [5]
0
0
Burswood Dermatology /ID# 243767 - Victoria Park
Query!
Recruitment hospital [6]
0
0
Sydney Skin /ID# 242277 - Newtown
Query!
Recruitment postcode(s) [1]
0
0
2228 - Miranda
Query!
Recruitment postcode(s) [2]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [3]
0
0
5042 - Bedford, Park
Query!
Recruitment postcode(s) [4]
0
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [5]
0
0
6100 - Victoria Park
Query!
Recruitment postcode(s) [6]
0
0
2042 - Newtown
Query!
Recruitment outside Australia
Country [1]
0
0
Argentina
Query!
State/province [1]
0
0
Buenos Aires
Query!
Country [2]
0
0
Argentina
Query!
State/province [2]
0
0
Ciudad Autonoma De Buenos Aires
Query!
Country [3]
0
0
Argentina
Query!
State/province [3]
0
0
Santa Fe
Query!
Country [4]
0
0
Argentina
Query!
State/province [4]
0
0
Caba
Query!
Country [5]
0
0
Austria
Query!
State/province [5]
0
0
Oberoesterreich
Query!
Country [6]
0
0
Austria
Query!
State/province [6]
0
0
Vorarlberg
Query!
Country [7]
0
0
Austria
Query!
State/province [7]
0
0
Wien
Query!
Country [8]
0
0
Canada
Query!
State/province [8]
0
0
Alberta
Query!
Country [9]
0
0
Canada
Query!
State/province [9]
0
0
Manitoba
Query!
Country [10]
0
0
Canada
Query!
State/province [10]
0
0
New Brunswick
Query!
Country [11]
0
0
Canada
Query!
State/province [11]
0
0
Newfoundland and Labrador
Query!
Country [12]
0
0
Canada
Query!
State/province [12]
0
0
Ontario
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
Quebec
Query!
Country [14]
0
0
Czechia
Query!
State/province [14]
0
0
Stredocesky Kraj
Query!
Country [15]
0
0
Czechia
Query!
State/province [15]
0
0
Ceske Budejovice
Query!
Country [16]
0
0
Czechia
Query!
State/province [16]
0
0
Olomouc
Query!
Country [17]
0
0
Czechia
Query!
State/province [17]
0
0
Prague
Query!
Country [18]
0
0
Czechia
Query!
State/province [18]
0
0
Praha
Query!
Country [19]
0
0
Greece
Query!
State/province [19]
0
0
Achaia
Query!
Country [20]
0
0
Greece
Query!
State/province [20]
0
0
Attiki
Query!
Country [21]
0
0
Greece
Query!
State/province [21]
0
0
Athens
Query!
Country [22]
0
0
Greece
Query!
State/province [22]
0
0
Larissa
Query!
Country [23]
0
0
Greece
Query!
State/province [23]
0
0
Thessaloniki
Query!
Country [24]
0
0
Hungary
Query!
State/province [24]
0
0
Hajdu-Bihar
Query!
Country [25]
0
0
Hungary
Query!
State/province [25]
0
0
Vas
Query!
Country [26]
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Hungary
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Budapest
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Hungary
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Pecs
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Hungary
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Szeged
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Israel
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H_efa
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Israel
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HaDarom
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Israel
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HaMerkaz
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Israel
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HaTsafon
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Israel
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Tel-Aviv
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Israel
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Italy
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Genova
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Italy
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Milano
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Italy
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Piemonte
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Italy
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Roma
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Italy
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Italy
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Italy
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Italy
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Italy
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Novara
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Italy
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Petrozavodsk
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Zuerich
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Taipei
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United Arab Emirates
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Abu Dhabi
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United Arab Emirates
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Dubai
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Ethics approval
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Summary
Brief summary
Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The
safety and effectiveness of upadacitinib for AD has been well-documented in previous studies,
however, important information is missing on the use patterns and outcomes with upadacitinib
in a real-world setting. Therefore, the purpose of this observational study is to help inform
real-world usage patterns regarding the safety and effectiveness and duration of response of
upadacitinib in adolescent and adult AD participants >=12 years old in the real-world
setting.
Upadacitinib is an approved drug being developed for the treatment of AD. Around 975
adolescent and adult participants who are prescribed upadacitinib for the treatment of AD in
routine clinical practice will be enrolled worldwide.
Participants will receive oral upadacitinib as prescribed by their physician. Data from these
participants will be collected for approximately 2 years.
There will be no additional burden for participants in this trial compared to their standard
of care. Participants will attend regular visits during the course of the study at a hospital
or clinic and will be asked to provide additional information by questionnaire at each visit.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05081557
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Public notes
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Contacts
Principal investigator
Name
0
0
ABBVIE INC.
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AbbVie
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Contact person for public queries
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0
0
ABBVIE CALL CENTER
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Phone
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0
844-663-3742
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05081557
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