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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05081557




Registration number
NCT05081557
Ethics application status
Date submitted
7/10/2021
Date registered
18/10/2021

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
Scientific title
Real World Utilization of Upadacitinib in Adult and Adolescent Patients Living With Moderate to Severe Atopic Dermatitis (AD-VISE)
Secondary ID [1] 0 0
P20-441
Universal Trial Number (UTN)
Trial acronym
AD-VISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants Receiving Upadacitinib - Participants receiving upadacitinib for atopic dermatitis.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Upadacitinib (UPA) Utilization Patterns
Timepoint [1] 0 0
Up to Approximately 24 Months
Primary outcome [2] 0 0
Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) 0/1
Timepoint [2] 0 0
Month 4
Primary outcome [3] 0 0
vIGA-AD 0/1 Among Participants Who Achieved vIGA-AD 0/1 at Month 4
Timepoint [3] 0 0
Month 24
Secondary outcome [1] 0 0
Modification of UPA or Concomitant AD Therapy and Associated Timing, Reasons
Timepoint [1] 0 0
Month 24
Secondary outcome [2] 0 0
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75
Timepoint [2] 0 0
Up to Approximately 24 months
Secondary outcome [3] 0 0
Percentage of Participants Achieving EASI 90
Timepoint [3] 0 0
Up to Approximately 24 Months
Secondary outcome [4] 0 0
Percentage of Participants Achieving EASI 100
Timepoint [4] 0 0
Up to Approximately 24 Months
Secondary outcome [5] 0 0
Percentage of Participants Achieving EASI <=1
Timepoint [5] 0 0
Up to Approximately 24 Months
Secondary outcome [6] 0 0
Percentage of Participants Achieving EASI <=5.9
Timepoint [6] 0 0
Up to Approximately 24 Months
Secondary outcome [7] 0 0
Percentage of Participants Achieving EASI <=7
Timepoint [7] 0 0
Up to Approximately 24 Months
Secondary outcome [8] 0 0
Percentage of Participants Achieving vIGA-AD 0/1
Timepoint [8] 0 0
Up to Approximately 24 Months (Excluding Month 4 - Primary Outcome)
Secondary outcome [9] 0 0
Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) 0/1
Timepoint [9] 0 0
Up to Approximately 24 Months
Secondary outcome [10] 0 0
Percentage of Participants Achieving WP-NRS <=3
Timepoint [10] 0 0
Up to Approximately 24 Months
Secondary outcome [11] 0 0
Percentage of Participants Achieving WP-NRS reduction >=4
Timepoint [11] 0 0
Up to Approximately 24 Months
Secondary outcome [12] 0 0
Percentage of Participants Achieving Patient Oriented Eczema Measurement (POEM) Score <=2
Timepoint [12] 0 0
Up to Approximately 24 Months
Secondary outcome [13] 0 0
Percentage of Participants Achieving POEM <=7
Timepoint [13] 0 0
Up to Approximately 24 Months
Secondary outcome [14] 0 0
Percentage of Participants Achieving POEM Reduction >=4
Timepoint [14] 0 0
Up to Approximately 24 Months
Secondary outcome [15] 0 0
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0/1
Timepoint [15] 0 0
Up to Approximately 24 Months
Secondary outcome [16] 0 0
Percentage of Participants Achieving DLQI Score <=5
Timepoint [16] 0 0
Up to Approximately 24 Months
Secondary outcome [17] 0 0
Percentage of Participants Achieving DLQI reduction >=4
Timepoint [17] 0 0
Up to Approximately 24 Months
Secondary outcome [18] 0 0
Percentage of Participants Achieving Atopic Dermatitis Control Tool (ADCT) <7 (control)
Timepoint [18] 0 0
Up to Approximately 24 Months
Secondary outcome [19] 0 0
Percentage of Participants Achieving ADCT reduction >=5
Timepoint [19] 0 0
Up to approximately 24 Months
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)
Timepoint [20] 0 0
Up to Approximately 24 Months
Secondary outcome [21] 0 0
Percentage of Participants Remaining on Upadacitinib Once Daily
Timepoint [21] 0 0
Up to Approximately 24 Months
Secondary outcome [22] 0 0
Percentage of Participants Achieving EASI 75 Among Participants Who Achieved EASI 75 at Month 4
Timepoint [22] 0 0
Up to Approximately 24 months
Secondary outcome [23] 0 0
Percentage of Participants Achieving EASI 90 Among Participants Who Achieved EASI 90 at Month 4
Timepoint [23] 0 0
Up to Approximately 24 months
Secondary outcome [24] 0 0
Percentage of Participants Achieving EASI 100 Among Participants Who Achieved EASI 100 at Month 4
Timepoint [24] 0 0
Up to Approximately 24 months
Secondary outcome [25] 0 0
Percentage of Participants Achieving vIGA-AD 0/1 Among Participants Who Achieved vIGA-AD at Month 4
Timepoint [25] 0 0
Up to Approximately 24 Months (Excluding Month 24 - Primary Outcome)
Secondary outcome [26] 0 0
Percentage of Participants Achieving WP-NRS 0/1 Among Participants Who Achieved WP-NRS 0/1 at Month 4
Timepoint [26] 0 0
Up to Approximately 24 Months
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
Timepoint [27] 0 0
Up to Approximately 24 Months
Secondary outcome [28] 0 0
Percentage of Participants Achieving ADCT Reduction <7 Among Participants Who Achieved ADCT Reduction <7 at Month 4
Timepoint [28] 0 0
Up to approximately 24 Months
Secondary outcome [29] 0 0
Absolute Score and Change from Baseline in EASI
Timepoint [29] 0 0
Up to Approximately 24 months
Secondary outcome [30] 0 0
Absolute Score and Change from Baseline in vIGA-AD
Timepoint [30] 0 0
Up to Approximately 24 months
Secondary outcome [31] 0 0
Absolute Score and Change from Baseline in Body Surface Area (BSA)
Timepoint [31] 0 0
Up to Approximately 24 Months
Secondary outcome [32] 0 0
Absolute Score and Change from Baseline in WP-NRS
Timepoint [32] 0 0
Up to Approximately 24 Months
Secondary outcome [33] 0 0
Absolute Score and Change from Baseline in POEM
Timepoint [33] 0 0
Up to Approximately 24 Months
Secondary outcome [34] 0 0
Absolute Score and Change from Baseline in DLQI
Timepoint [34] 0 0
Up to Approximately 24 Months
Secondary outcome [35] 0 0
Absolute Score and Change from Baseline in ADCT
Timepoint [35] 0 0
Up to Approximately 24 months
Secondary outcome [36] 0 0
Absolute Score and Change from Baseline in PGIT-AD
Timepoint [36] 0 0
Up to Approximately 24 Months
Secondary outcome [37] 0 0
Change from Baseline in Flare Frequency and Duration
Timepoint [37] 0 0
Up to Approximately 24 Months
Secondary outcome [38] 0 0
Change from Baseline in the Number of AD-Related Physician Office or Hospital Visits
Timepoint [38] 0 0
Up to Approximately 24 Months
Secondary outcome [39] 0 0
Absolute Score and Change from Baseline in Work Productivity and Activity Impairment Index for Atopic Dermatitis (WPAI-AD)
Timepoint [39] 0 0
Up to Approximately 24 Months
Secondary outcome [40] 0 0
Time to Achieve EASI 75
Timepoint [40] 0 0
Up to Approximately 24 months
Secondary outcome [41] 0 0
Time to Achieve EASI 90
Timepoint [41] 0 0
Up to Approximately 24 months
Secondary outcome [42] 0 0
Time to Achieve EASI 100
Timepoint [42] 0 0
Up to Approximately 24 months
Secondary outcome [43] 0 0
Time to Achieve vIGA-AD 0/1
Timepoint [43] 0 0
Up to Approximately 24 Months
Secondary outcome [44] 0 0
Time to Achieve WP-NRS 0/1
Timepoint [44] 0 0
Up to Approximately 24 Months
Secondary outcome [45] 0 0
Time to Achieve DLQI Score of 0/1
Timepoint [45] 0 0
Up to Approximately 24 Months
Secondary outcome [46] 0 0
Time to Achieve POEM <=2
Timepoint [46] 0 0
Up to Approximately 24 Months
Secondary outcome [47] 0 0
Time to Achieve ADCT <7
Timepoint [47] 0 0
Up to Approximately 24 Months
Secondary outcome [48] 0 0
Time-Weighted EASI Score
Timepoint [48] 0 0
Up to Approximately 24 Months
Secondary outcome [49] 0 0
Time-Weighted vIGA-AD Score
Timepoint [49] 0 0
Up to Approximately 24 Months
Secondary outcome [50] 0 0
Time-Weighted WP-NRS Score
Timepoint [50] 0 0
Up to Approximately 24 Months
Secondary outcome [51] 0 0
Time-Weighted DLQI Score
Timepoint [51] 0 0
Up to Approximately 24 Months
Secondary outcome [52] 0 0
Percentage of Participants Achieving Treatment Target EASI <8
Timepoint [52] 0 0
Up to Approximately 24 Months
Secondary outcome [53] 0 0
Percentage of Participants Achieving Treatment Target DLQI <=5
Timepoint [53] 0 0
Up to Approximately 24 Months
Secondary outcome [54] 0 0
Percentage of Participants Achieving Treatment Target WP-NRS <=4
Timepoint [54] 0 0
Up to Approximately 24 Months
Secondary outcome [55] 0 0
Percentage of Participants Achieving Combined Treatment Targets of EASI <8, DLQI <=5, and WP-NRS <=4
Timepoint [55] 0 0
Up to Approximately 24 Months

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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants who are currently participating in interventional research (not including non-interventional study, post-marketing observational study, or registry participation).

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/10/2026
Actual
Sample size
Target
975
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Kingsway Dermatology & Aesthetics /ID# 242276 - Miranda
Recruitment hospital [2] 0 0
Veracity Clinical Research /ID# 242275 - Woolloongabba
Recruitment hospital [3] 0 0
Flinders Medical Centre /ID# 242162 - Bedford, Park
Recruitment hospital [4] 0 0
Sinclair Dermatology - Melbourne /ID# 242163 - East Melbourne
Recruitment hospital [5] 0 0
Burswood Dermatology /ID# 243767 - Victoria Park
Recruitment hospital [6] 0 0
Sydney Skin /ID# 242277 - Newtown
Recruitment postcode(s) [1] 0 0
2228 - Miranda
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5042 - Bedford, Park
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
6100 - Victoria Park
Recruitment postcode(s) [6] 0 0
2042 - Newtown
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad Autonoma De Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Santa Fe
Country [4] 0 0
Argentina
State/province [4] 0 0
Caba
Country [5] 0 0
Austria
State/province [5] 0 0
Oberoesterreich
Country [6] 0 0
Austria
State/province [6] 0 0
Vorarlberg
Country [7] 0 0
Austria
State/province [7] 0 0
Wien
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
Manitoba
Country [10] 0 0
Canada
State/province [10] 0 0
New Brunswick
Country [11] 0 0
Canada
State/province [11] 0 0
Newfoundland and Labrador
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Czechia
State/province [14] 0 0
Praha 17
Country [15] 0 0
Czechia
State/province [15] 0 0
Stredocesky Kraj
Country [16] 0 0
Czechia
State/province [16] 0 0
Olomouc
Country [17] 0 0
Czechia
State/province [17] 0 0
Prague
Country [18] 0 0
Czechia
State/province [18] 0 0
Praha
Country [19] 0 0
Greece
State/province [19] 0 0
Achaia
Country [20] 0 0
Greece
State/province [20] 0 0
Attiki
Country [21] 0 0
Greece
State/province [21] 0 0
Evrytania
Country [22] 0 0
Greece
State/province [22] 0 0
Athens
Country [23] 0 0
Greece
State/province [23] 0 0
Larissa
Country [24] 0 0
Hungary
State/province [24] 0 0
Hajdu-Bihar
Country [25] 0 0
Hungary
State/province [25] 0 0
Nograd
Country [26] 0 0
Hungary
State/province [26] 0 0
Vas
Country [27] 0 0
Hungary
State/province [27] 0 0
Budapest
Country [28] 0 0
Hungary
State/province [28] 0 0
Szeged
Country [29] 0 0
Israel
State/province [29] 0 0
H_efa
Country [30] 0 0
Israel
State/province [30] 0 0
HaDarom
Country [31] 0 0
Israel
State/province [31] 0 0
HaMerkaz
Country [32] 0 0
Israel
State/province [32] 0 0
HaTsafon
Country [33] 0 0
Israel
State/province [33] 0 0
Tel-Aviv
Country [34] 0 0
Israel
State/province [34] 0 0
Yerushalayim
Country [35] 0 0
Italy
State/province [35] 0 0
Genova
Country [36] 0 0
Italy
State/province [36] 0 0
Milano
Country [37] 0 0
Italy
State/province [37] 0 0
Piemonte
Country [38] 0 0
Italy
State/province [38] 0 0
Roma
Country [39] 0 0
Italy
State/province [39] 0 0
Salerno
Country [40] 0 0
Italy
State/province [40] 0 0
Bari
Country [41] 0 0
Italy
State/province [41] 0 0
Catania
Country [42] 0 0
Italy
State/province [42] 0 0
Messina
Country [43] 0 0
Italy
State/province [43] 0 0
Novara
Country [44] 0 0
Italy
State/province [44] 0 0
Vicenza
Country [45] 0 0
Mexico
State/province [45] 0 0
Jalisco
Country [46] 0 0
Mexico
State/province [46] 0 0
Nuevo Leon
Country [47] 0 0
Mexico
State/province [47] 0 0
Oaxaca
Country [48] 0 0
Mexico
State/province [48] 0 0
Puebla
Country [49] 0 0
Mexico
State/province [49] 0 0
Yucatan
Country [50] 0 0
Mexico
State/province [50] 0 0
Ciudad de Mexico
Country [51] 0 0
Mexico
State/province [51] 0 0
Mexico City
Country [52] 0 0
Mexico
State/province [52] 0 0
Toluca
Country [53] 0 0
Poland
State/province [53] 0 0
Lodzkie
Country [54] 0 0
Poland
State/province [54] 0 0
Lubelskie
Country [55] 0 0
Poland
State/province [55] 0 0
Malopolskie
Country [56] 0 0
Poland
State/province [56] 0 0
Mazowieckie
Country [57] 0 0
Poland
State/province [57] 0 0
Podkarpackie
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Chelyabinskaya Oblast
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Krasnodarskiy Kray
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Kurskaya Oblast
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Moskva
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Ryazanskaya Oblast
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Stavropol Skiy Kray
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Tatarstan, Respublika
Country [65] 0 0
Spain
State/province [65] 0 0
Barcelona
Country [66] 0 0
Spain
State/province [66] 0 0
La Rioja
Country [67] 0 0
Spain
State/province [67] 0 0
Las Palmas
Country [68] 0 0
Spain
State/province [68] 0 0
Murcia
Country [69] 0 0
Spain
State/province [69] 0 0
Santa Cruz De Tenerife
Country [70] 0 0
Spain
State/province [70] 0 0
Vizcaya
Country [71] 0 0
Spain
State/province [71] 0 0
Granada
Country [72] 0 0
Spain
State/province [72] 0 0
Huelva
Country [73] 0 0
Spain
State/province [73] 0 0
Jaen
Country [74] 0 0
Spain
State/province [74] 0 0
Lugo
Country [75] 0 0
Spain
State/province [75] 0 0
Malaga
Country [76] 0 0
Spain
State/province [76] 0 0
Salamanca
Country [77] 0 0
Spain
State/province [77] 0 0
Santa Cruz de Tenerife
Country [78] 0 0
Spain
State/province [78] 0 0
Sevilla
Country [79] 0 0
Spain
State/province [79] 0 0
Valladolid
Country [80] 0 0
Switzerland
State/province [80] 0 0
Aargau
Country [81] 0 0
Switzerland
State/province [81] 0 0
Nidwalden
Country [82] 0 0
Switzerland
State/province [82] 0 0
Sankt Gallen
Country [83] 0 0
Switzerland
State/province [83] 0 0
Telangana
Country [84] 0 0
Switzerland
State/province [84] 0 0
Ticino
Country [85] 0 0
Switzerland
State/province [85] 0 0
Valais
Country [86] 0 0
Switzerland
State/province [86] 0 0
Zuerich
Country [87] 0 0
Taiwan
State/province [87] 0 0
Keelung
Country [88] 0 0
Taiwan
State/province [88] 0 0
Taipei
Country [89] 0 0
Taiwan
State/province [89] 0 0
Taipei City
Country [90] 0 0
Taiwan
State/province [90] 0 0
Taoyuan City
Country [91] 0 0
United Arab Emirates
State/province [91] 0 0
Abu Dhabi
Country [92] 0 0
United Arab Emirates
State/province [92] 0 0
Dubai

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05081557