A Study to Assess Real-World Use, Safety, and Effectiveness of Oral Upadacitinib in Adult and Adolescent (>=12 Years Old) Participants With Atopic Dermatitis
AD-VISE
Real World Utilization of Upadacitinib in Adult and Adolescent Patients Living With Moderate to Severe Atopic Dermatitis (AD-VISE)
1 other identifier
observational
873
15 countries
135
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Longer than P75 for all trials
135 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2021
CompletedFirst Posted
Study publicly available on registry
October 18, 2021
CompletedStudy Start
First participant enrolled
November 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
August 14, 2025
August 1, 2025
4.9 years
October 7, 2021
August 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Upadacitinib (UPA) Utilization Patterns
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.
Up to Approximately 24 Months
Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) 0/1
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.
Month 4
vIGA-AD 0/1 Among Participants Who Achieved vIGA-AD 0/1 at Month 4
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.
Month 24
Secondary Outcomes (55)
Modification of UPA or Concomitant AD Therapy and Associated Timing, Reasons
Month 24
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75
Up to Approximately 24 months
Percentage of Participants Achieving EASI 90
Up to Approximately 24 Months
Percentage of Participants Achieving EASI 100
Up to Approximately 24 Months
Percentage of Participants Achieving EASI <=1
Up to Approximately 24 Months
- +50 more secondary outcomes
Study Arms (1)
Participants Receiving Upadacitinib
Participants receiving upadacitinib for atopic dermatitis.
Eligibility Criteria
Adolescents (12-17 years of age at baseline) and adults (\>=18 years of age at baseline), with a physician-confirmed diagnosis of atopic dermatitis (AD), who are prescribed upadacitinib according to the local label and local practice.
You may qualify if:
- 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.
You may not qualify if:
- \- Participants who are currently participating in interventional research (not including non-interventional study, post-marketing observational study, or registry participation).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (140)
Hospital Universitario Austral /ID# 241607
Pilar, Buenos Aires, 1629, Argentina
Buenos Aires Skin /ID# 241606
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1055, Argentina
CEDIC Centro de Investigaciones Clinicas /ID# 241605
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425, Argentina
Instituto de Neumonologia y Dermatologia /ID# 241604
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425, Argentina
Centro Respiratorio Infantil /ID# 241609
Rosario, Santa Fe Province, 2000, Argentina
Hospital Italiano /ID# 241608
CABA, C1199ABB, Argentina
Kingsway Dermatology & Aesthetics /ID# 242276
Miranda, New South Wales, 2228, Australia
Veracity Clinical Research /ID# 242275
Woolloongabba, Queensland, 4102, Australia
Flinders Medical Centre /ID# 242162
Bedford Park, South Australia, 5042, Australia
Sinclair Dermatology - Melbourne /ID# 242163
East Melbourne, Victoria, 3002, Australia
Burswood Dermatology /ID# 243767
Victoria Park, Western Australia, 6100, Australia
Sydney Skin /ID# 242277
Newtown, 2042, Australia
Ordensklinikum Linz GmbH Elisabethinen /ID# 246565
Linz, Upper Austria, 4010, Austria
Klinikum Wels-Grieskirchen GmbH /ID# 247369
Wels, Upper Austria, 4600, Austria
Medizin am Hauptbahnhof /ID# 246567
Vienna, Vienna, 1100, Austria
EZW HAUT Entzuendungszentrum Wien /ID# 246566
Vienna, Vienna, 1130, Austria
Dr. Achim Schneeberger /ID# 247370
Nenzing, Vorarlberg, 6710, Austria
Rejuvenation Dermatology - Edmonton Downtown /ID# 240377
Edmonton, Alberta, T5J 3S9, Canada
Winnipeg Clinic /ID# 239603
Winnipeg, Manitoba, R3C 0N2, Canada
Dr. Irina Turchin PC Inc. /ID# 240358
Fredericton, New Brunswick, E3B 1G9, Canada
Karma Clinical Trials /ID# 239602
St. John's, Newfoundland and Labrador, A1A 4Y3, Canada
NewLab Clinical Research Inc. /ID# 239600
St. John's, Newfoundland and Labrador, A1C 2H5, Canada
Dr Melinda Gooderham Medicine Profession /ID# 239745
Cobourg, Ontario, K9A 0Z4, Canada
Dr. Lyne Giroux Medicine Professional Corporation /ID# 240084
Greater Sudbury, Ontario, P3C 1X3, Canada
Lima's Excellence in Allergy and Dermatology Research Inc /ID# 239854
Hamilton, Ontario, L8L 3C3, Canada
Lynde Institute for Dermatology /ID# 240025
Markham, Ontario, L3P 1X2, Canada
Gordon Sussman Medicine Professional Corporation /ID# 243383
North York, Ontario, M3B 3S6, Canada
JRB Research /ID# 241862
Ottawa, Ontario, K1H 7X3, Canada
Dr. Michael Cecchini Medicine Professional Corporation /ID# 239605
Richmond Hill, Ontario, L4B 1L1, Canada
North York Research Inc /ID# 253191
Toronto, Ontario, M2N 3A6, Canada
Canadian Dermatology Centre /ID# 240585
Toronto, Ontario, M3B 0A7, Canada
Centricity Research - Toronto Dermatology /ID# 241019
Toronto, Ontario, M4C 1L1, Canada
Dr Maksym Breslavets Medicine Professional Corporation /ID# 239741
Whitby, Ontario, L1N 8M7, Canada
Clinique D /ID# 239601
Laval, Quebec, H7N 6L2, Canada
Roula Rassi MD Inc /ID# 252562
Laval, Quebec, H7P 4K7, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 239604
Saint-Jérôme, Quebec, J7Z 7E2, Canada
Clinique de Dermatologie du Haut-Richelieu /ID# 239742
St-Jean Sur Le Richelieu, Quebec, J3A 1B5, Canada
Nemocnice Na Bulovce /ID# 246482
Prague, Central Bohemia, 180 81, Czechia
Nemocnice Ceske Budejovice a.s. /ID# 246479
České Budějovice, Praha 17, 370 01, Czechia
Fakultni nemocnice Olomouc /ID# 251177
Olomouc, 779 00, Czechia
Fakultni nemocnice Kralovske Vinohrady /ID# 250792
Prague, 100 34, Czechia
Duplicate_Fakultni Nemocnice v Motole /ID# 246480
Prague, 150 00, Czechia
Olympion General Clinic /ID# 261694
Pátrai, Achaia, 25443, Greece
Hygeia Hospital /ID# 254188
Amaroussio, Attica, 15123, Greece
401 GSNA - 401 Army General Hospital /ID# 253222
Athens, Attica, 11527, Greece
401 GSNA - 401 Army General Hospital /ID# 253228
Athens, Attica, 11527, Greece
University General Hospital Attikon /ID# 253221
Athens, Attica, 12462, Greece
General Hospital Andreas Syggros /ID# 253220
Athens, Attica, 16121, Greece
Tzaneio general hospital of Piraeus /ID# 253223
Piraeus, Attica, 18536, Greece
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 253225
Thessaloniki, Evrytania, 54643, Greece
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 253230
Thessaloniki, Evrytania, 54643, Greece
Papageorgiou General Hospital /ID# 253226
Thessaloniki, Evrytania, 56429, Greece
Naval Hospital of Athens /ID# 253229
Athens, 11521, Greece
University General Hospital of Larissa /ID# 254216
Larissa, 41110, Greece
Semmelweis Egyetem /ID# 239948
Budapest, Budapest, 1085, Hungary
Debreceni Egyetem-Klinikai Kozpont /ID# 239949
Debrecen, Hajdú-Bihar, 4032, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 239950
Pecs, Nógrád megye, 7624, Hungary
Szegedi Tudományegyetem /ID# 239947
Szeged, Szeged, 6720, Hungary
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 239951
Szombathely, Vas County, 9700, Hungary
Duplicate_Kaplan Medical Center /ID# 244903
Rehovot, Central District, 7661041, Israel
Leumit /ID# 260022
Rehovot, Central District, 9458414, Israel
HaEmek Medical Center /ID# 247834
Afula, H_efa, 1834111, Israel
Rambam Health Care Campus /ID# 244904
Haifa, H_efa, 3109601, Israel
Maccabi /ID# 252598
Haifa, H_efa, 7176250, Israel
Shaare Zedek Medical Center /ID# 247833
Jerusalem, Jerusalem, 91031, Israel
ZIV Medical Center /ID# 244908
Safed, Northern District, 13100, Israel
The Edith Wolfson Medical Center /ID# 244902
Ashkelon, Southern District, 5822000, Israel
Sheba Medical Center /ID# 244905
Ramat Gan, Tel Aviv, 52621, Israel
Tel Aviv Sourasky Medical Center /ID# 244907
Tel Aviv, Tel Aviv, 6423906, Israel
A.O.U. Consorziale Policlinico di Bari /ID# 254612
Bari, Bari, 70124, Italy
AOU Policlinico G. Rodolico - San Marco /ID# 255707
Catania, Catania, 95123, Italy
Ospedale San Martino /ID# 255081
Genoa, Genova, 16132, Italy
AOU Gaetano Martino /ID# 255080
Messina, Messina, 98122, Italy
IRCCS Ospedale San Raffaele /ID# 255285
Milan, Milano, 20132, Italy
AOU Citta della Salute e della Scienza di Torino /ID# 254615
Turin, Piedmont, 10126, Italy
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 255283
Roma, Roma, 00128, Italy
AOU San Giovanni e Ruggi Salerno - Presidio Ospedaliero S.M.I. dell'Olmo /ID# 254689
Cava de' Tirreni, Salerno, 84013, Italy
Azienda ULSS 8 Berica /ID# 255011
Vicenza, Vicenza, 36100, Italy
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 254613
Novara, 28100, Italy
Centro de Investigacion Biologica y Terapia Avanzada SC (CIMBYTA) /ID# 243820
Guadalajara, Jalisco, 44130, Mexico
Centro Dermatologico Del Country S de Rl de Cv /Id# 243818
Guadalajara, Jalisco, 44610, Mexico
Grupo Clinico Catei Sociedad Civil /Id# 243809
Guadalajara, Jalisco, 44657, Mexico
Consultorio Medico Privado Desiree Larenas Linnemann /Id# 244150
Mexico City, Mexico City, 14050, Mexico
Welsh Derm Centro de Especialidades Medicas /Id# 268403
Monterrey, Nuevo León, 64060, Mexico
Consultorio Medico Privado Alejandra Macias Weinmann /Id# 244159
Monterrey, Nuevo León, 64623, Mexico
Clinica Dermassad /Id# 264048
San Pedro Garza García, Nuevo León, 66220, Mexico
Consultorio Medico Privado Cipactli Ariel Navarro Hernandez /Id# 244165
Oaxaca City, Oaxaca, 68000, Mexico
Consultorio Medico Privado Yuri Igor Lopez Carrera /Id# 244164
San Andrés Cholula, Puebla, 72820, Mexico
Neki Servicios Medicos Profesionales S D Rl de Cv /Id# 243817
Toluca, State of Mexico, 50120, Mexico
Consultorio Privado Leslie Lourdes Rodriguez /Id# 243819
Mérida, Yucatán, 97203, Mexico
Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiova /ID# 243856
Mexico City, 11650, Mexico
Maciej Pastuszczak Indywidualna Praktyka Lekarska /ID# 253105
Krakow, Lesser Poland Voivodeship, 30-383, Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny, /ID# 253106
Lublin, Lublin Voivodeship, 20-573, Poland
Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 252447
Warsaw, Masovian Voivodeship, 02-507, Poland
Prywatna Praktyka Lekarska Witold Owczarek /ID# 252448
Warsaw, Masovian Voivodeship, 02-962, Poland
KSW nr1 w Rzeszowie /ID# 251251
Rzeszów, Podkarpackie Voivodeship, 35-055, Poland
Dermoklinika Medical Center /ID# 251249
Lodz, Łódź Voivodeship, 90-436, Poland
Chelyabinsk Regional Clinical Dermatovenerologic Dispensary /ID# 248262
Chelyabinsk, Chelyabinsk Oblast, 454048, Russia
Clinical Dermatovenerology Dispensary /ID# 245225
Krasnodar, Krasnodarskiy Kray, 350020, Russia
Republican hospital named after V.A. Baranov /ID# 245230
Petrozavodsk, Kursk Oblast, 185019, Russia
National Research Center Institute of Immunology of the FMBA of Russia /ID# 245221
Moscow, Moscow, 115522, Russia
Research and Clinical Center for Hematology, Oncology and Immunology, Ryazan Sta /ID# 245220
Ryazan, Ryazan Oblast, 390029, Russia
LLC Scientific Medical Center for General Therapy and Pharmacology /ID# 245229
Stavropol, Stavropol Kray, 355000, Russia
LLC Medical Center ABC of Health /ID# 244816
Kazan', Tatarstan, Respublika, 420111, Russia
Hospital Universitario Germans Trias i Pujol /ID# 248512
Badalona, Barcelona, 08916, Spain
Hospital Parc de Salut del Mar /ID# 258675
Barcelona, Barcelona, 08003, Spain
Hospital Santa Creu i Sant Pau /ID# 248511
Barcelona, Barcelona, 08041, Spain
Hospital Universitari de Bellvitge /ID# 248513
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitari Mútua Terrassa /ID# 254292
Terrassa, Barcelona, 08221, Spain
Hospital Universitario Virgen de las Nieves /ID# 248528
Granada, Granada, 18014, Spain
Hospital Universitario Clinico San Cecilio /ID# 248530
Granada, Granada, 18016, Spain
Hospital Juan Ramon Jimenez /ID# 251960
Huelva, Huelva, 21005, Spain
Hospital Universitario de Jaen /ID# 251959
Jaén, Jaen, 23007, Spain
Hospital San Pedro /ID# 248538
Logroño, La Rioja, 26006, Spain
Hospital Universitario Dr. Negrin /ID# 248533
Las Palmas de Gran Canaria, Las Palmas, 35019, Spain
Hospital Universitario Lucus Augusti /ID# 248507
Lugo, Lugo, 27003, Spain
Hospital Universitario Virgen de la Victoria /ID# 248531
Málaga, Malaga, 29010, Spain
Hospital Santa María del Rosell /ID# 251956
Cartagena, Murcia, 30203, Spain
Hospital Universitario de Salamanca /ID# 253356
Salamanca, Salamanca, 37711, Spain
Hospital Universitario Canarias /ID# 251957
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain
Hospital Universitario Nuestra Señora de Candelaria /ID# 251961
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010, Spain
Hospital Universitario Virgen del Rocio /ID# 248527
Seville, Sevilla, 41013, Spain
Hospital Clinico Universitario de Valladolid /ID# 253355
Valladolid, Valladolid, 47003, Spain
Hospital Universitario Basurto /ID# 248508
Bilbao, Vizcaya, 48013, Spain
Kantonsspital Aarau AG /ID# 245517
Aarau, Canton of Aargau, 5001, Switzerland
Dermatology & Skin Care Clinic /ID# 238348
Buochs, Canton of Nidwalden, 6374, Switzerland
Kantonsspital St. Gallen /ID# 239244
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
University Hospital Zurich /ID# 240076
Zurich, Canton of Zurich, 8006, Switzerland
EOC Ospedale Regionale di Bellinzona e Valli /ID# 239246
Bellinzona, Canton Ticino, 6500, Switzerland
Haut- und Laserzentrum Weinfelden /ID# 239248
Weinfelden, Telangana, 8570, Switzerland
Basile Darbellay SA /ID# 239245
Orsières, Valais, 1937, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 244758
Kaohsiung City, Keelung, 807, Taiwan
Chung Shan Medical University Hospital /ID# 244757
Taichung, Keelung, 40201, Taiwan
National Taiwan University Hospital /ID# 244754
Taipei City, Taipei, 100, Taiwan
Chang Gung Memorial Foundation-Taipei Branch /ID# 244760
Taipei, 05406, Taiwan
Taipei Veterans General Hosp /ID# 244759
Taipei, 11217, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 244756
Taoyuan, 333, Taiwan
New Medical Center Hospital /ID# 245106
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
Safa Clinic /ID# 248492
Dubai, Dubai, United Arab Emirates
Tawam Hospital /ID# 249696
Abu Dhabi, United Arab Emirates
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2021
First Posted
October 18, 2021
Study Start
November 17, 2021
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
August 14, 2025
Record last verified: 2025-08