Atopic DermatitisADVISE MCOSNCT05081557
A Study to Assess Real-World Use, Safety, and Effectiveness of Oral Upadacitinib in Adult and Adolescent (>=12 Years Old) Participants With Atopic Dermatitis
An observational study of Atopic Dermatitis, run by AbbVie at 140 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 873 participants
- Where
- 140 sitesin 16 countries
- Study dates
- 17 Nov 2021to 2 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- Participants who are currently participating in interventional research (not including non-interventional study, post-marketing observational study, or registry participation).
Trial locations and contacts
140 sites in 16 countries.
140 sites in 16 countries
Canada20 sites
Dr Melinda Gooderham Medicine Profession /ID# 239745
Cobourg, Ontario, K9A 0Z4
Rejuvenation Dermatology - Edmonton Downtown /ID# 240377
Edmonton, Alberta, T5J 3S9
Dr. Irina Turchin PC Inc. /ID# 240358
Fredericton, New Brunswick, E3B 1G9
Dr. Lyne Giroux Medicine Professional Corporation /ID# 240084
Greater Sudbury, Ontario, P3C 1X3
Lima's Excellence in Allergy and Dermatology Research Inc /ID# 239854
Hamilton, Ontario, L8L 3C3
Clinique D /ID# 239601
Laval, Quebec, H7N 6L2
Roula Rassi MD Inc /ID# 252562
Laval, Quebec, H7P 4K7
Lynderm Research Inc /ID# 240025
Markham, Ontario, L3P 1X2
Gordon Sussman Medicine Professional Corporation /ID# 243383
North York, Ontario, M3B 3S6
JRB Research /ID# 241862
Ottawa, Ontario, K1H 7X3
Dr. Michael Cecchini Medicine Professional Corporation /ID# 239605
Richmond Hill, Ontario, L4B 1L1
Dre Angelique Gagne-Henley M.D. inc. /ID# 239604
Saint-Jérôme, Quebec, J7Z 7E2
Clinique de Dermatologie du Haut-Richelieu /ID# 239742
St-Jean Sur Le Richelieu, Quebec, J3A 1B5
Karma Clinical Trials /ID# 239602
St. John's, Newfoundland and Labrador, A1A 4Y3
NewLab Clinical Research Inc. /ID# 239600
St. John's, Newfoundland and Labrador, A1C 2H5
North York Research Inc /ID# 253191
Toronto, Ontario, M2N 3A6
Canadian Dermatology Centre /ID# 240585
Toronto, Ontario, M3B 0A7
Centricity Research - Toronto Dermatology /ID# 241019
Toronto, Ontario, M4C 1L1
Dr Maksym Breslavets Medicine Professional Corporation /ID# 239741
Whitby, Ontario, L1N 8M7
Winnipeg Clinic /ID# 239603
Winnipeg, Manitoba, R3C 0N2
Spain20 sites
Hospital Universitario Germans Trias i Pujol /ID# 248512
Badalona, Barcelona, 08916
Hospital Parc de Salut del Mar /ID# 258675
Barcelona, 08003
Hospital Santa Creu i Sant Pau /ID# 248511
Barcelona, 08041
Hospital Universitario Basurto /ID# 248508
Bilbao, Vizcaya, 48013
Hospital Santa María del Rosell /ID# 251956
Cartagena, Murcia, 30203
Hospital Universitario Virgen de las Nieves /ID# 248528
Granada, 18014
Duplicate_Hospital Universitario Clinico San Cecilio /ID# 248530
Granada, 18016
Hospital Juan Ramon Jimenez /ID# 251960
Huelva, 21005
Hospital Universitario de Jaen /ID# 251959
Jaén, 23007
Hospital Universitari de Bellvitge /ID# 248513
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario Dr. Negrin /ID# 248533
Las Palmas de Gran Canaria, Las Palmas, 35019
Hospital San Pedro /ID# 248538
Logroño, La Rioja, 26006
Hospital Universitario Lucus Augusti /ID# 248507
Lugo, 27003
Hospital Universitario Virgen de la Victoria /ID# 248531
Málaga, 29010
Hospital Universitario de Salamanca /ID# 253356
Salamanca, 37711
Hospital Universitario Canarias /ID# 251957
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Hospital Universitario Nuestra Señora de Candelaria /ID# 251961
Santa Cruz de Tenerife, 38010
Hospital Universitario Virgen del Rocio /ID# 248527
Seville, 41013
Hospital Universitari Mutua Terrassa /ID# 254292
Terrassa, Barcelona, 08221
Hospital Clinico Universitario de Valladolid /ID# 253355
Valladolid, 47003
Mexico13 sites
Centro de Investigacion Biologica y Terapia Avanzada SC (CIMBYTA) /ID# 243820
Guadalajara, Jalisco, 44130
Centro Dermatologico Del Country S de Rl de Cv /Id# 243818
Guadalajara, Jalisco, 44610
Grupo Clinico Catei Sociedad Civil /Id# 243809
Guadalajara, Jalisco, 44657
Consultorio Privado Leslie Lourdes Rodriguez /Id# 243819
Mérida, Yucatán, 97203
Duplicate_Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedade /ID# 243856
Mexico City, Mexico City, 11650
Consultorio Medico Privado Desiree Larenas Linnemann /Id# 244150
Mexico City, 14050
Welsh Derm Centro de Especialidades Medicas /Id# 268403
Monterrey, Nuevo León, 64060
Consultorio Medico Privado Alejandra Macias Weinmann /Id# 244159
Monterrey, Nuevo León, 64623
Consultorio Medico Privado Cipactli Ariel Navarro Hernandez /Id# 244165
Oaxaca City, Oaxaca, 68000
Consultorio Medico Privado Yuri Igor Lopez Carrera /Id# 244164
San Andrés Cholula, Puebla, 72820
Clinica Dermassad /Id# 264048
San Pedro Garza García, Nuevo León, 66220
L Derm Clinica Dermatologica /Id# 266909
Tijuana, Estado de Baja California, 22010
Neki Servicios Medicos Profesionales S D Rl de Cv /Id# 243817
Toluca, 50120
Greece12 sites
Hygeia Hospital /ID# 254188
Amaroussio, Attica, 15123
401 GSNA - 401 Army General Hospital /ID# 253222
Athens, Attica, 11527
401 GSNA - 401 Army General Hospital /ID# 253228
Athens, Attica, 11527
General Hospital Andreas Syggros /ID# 253220
Athens, Attica, 16121
Naval Hospital of Athens /ID# 253229
Athens, 11521
University General Hospital Attikon /ID# 253221
Chaïdári, Attica, 12462
University General Hospital of Larissa /ID# 254216
Larissa, 41110
Olympion General Clinic /ID# 261694
Pátrai, Achaia, 26443
Tzaneio general hospital of Piraeus /ID# 253223
Piraeus, Attica, 18536
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 253225
Thessaloniki, 54643
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 253230
Thessaloniki, 54643
Papageorgiou General Hospital /ID# 253226
Thessaloniki, 56429
Israel10 sites
Haemek Medical Center /ID# 247834
Afula, Haifa District, 1834111
Rambam Health Care Campus /ID# 244904
Haifa, 3109601
Maccabi /ID# 252598
Haifa, 7176250
The Edith Wolfson Medical Center /ID# 244902
Holon, Southern District, 5822000
Shaare Zedek Medical Center /ID# 247833
Jerusalem, Jerusalem, 91031
Sheba Medical Center /ID# 244905
Ramat Gan, Tel Aviv, 52621
Duplicate_Kaplan Medical Center /ID# 244903
Rehovot, Central District, 7661041
Leumit /ID# 260022
Rehovot, Central District, 9458414
ZIV Medical Center /ID# 244908
Safed, Northern District, 13100
Tel Aviv Sourasky Medical Center /ID# 244907
Tel Aviv, Tel Aviv, 6423906
Italy10 sites
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari /ID# 254612
Bari, 70124
AOU Policlinico G. Rodolico - San Marco /ID# 255707
Catania, 95123
AOU San Giovanni e Ruggi Salerno - Presidio Ospedaliero S.M.I. dell'Olmo /ID# 254689
Cava de' Tirreni, Salerno, 84013
Ospedale San Martino /ID# 255081
Genova, 16132
Azienda Ospedaliera Universitaria Gaetano Martino /ID# 255080
Messina, 98125
IRCCS Ospedale San Raffaele /ID# 255285
Milan, Milano, 20132
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 254613
Novara, 28100
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 255283
Roma, 00128
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 254615
Turin, Piedmont, 10126
Azienda ULSS 8 Berica /ID# 255011
Vicenza, 36100
Russia7 sites
Chelyabinsk Regional Clinical Dermatovenerologic Dispensary /ID# 248262
Chelyabinsk, Chelyabinsk Oblast, 454048
LLC Medical Center ABC of Health /ID# 244816
Kazan', Tatarstan, Respublika, 420111
Clinical Dermatovenerology Dispensary /ID# 245225
Krasnodar, Krasnodarskiy Kray, 350020
National Research Center Institute of Immunology of the FMBA of Russia /ID# 245221
Moscow, Moscow, 115522
Republican hospital named after V.A. Baranov /ID# 245230
Petrozavodsk, Murmansk Oblast, 185019
Research and Clinical Center for Hematology, Oncology and Immunology, Ryazan Sta /ID# 245220
Ryazan, Ryazan Oblast, 390029
LLC Scientific Medical Center for General Therapy and Pharmacology /ID# 245229
Stavropol, Stavropol Kray, 355000
Switzerland7 sites
Kantonsspital Aarau AG /ID# 245517
Aarau, Canton of Aargau, 5001
EOC Ospedale Regionale di Bellinzona e Valli /ID# 239246
Bellinzona, Canton Ticino, 6500
Dermatology & Skin Care Clinic /ID# 238348
Buochs, Canton of Nidwalden, 6374
Basile Darbellay SA /ID# 239245
Orsières, Valais, 1937
Kantonsspital St. Gallen /ID# 239244
Sankt Gallen, Canton of St. Gallen, 9007
Haut- und Laserzentrum Weinfelden /ID# 239248
Weinfelden, Telangana, 8570
University Hospital Zurich /ID# 240076
Zurich, Canton of Zurich, 8091
Argentina6 sites
Hospital Italiano /ID# 241608
CABA, C1199ABB
Buenos Aires Skin /ID# 241606
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1055
CEDIC Centro de Investigaciones Clinicas /ID# 241605
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425
Instituto de Neumonologia y Dermatologia /ID# 241604
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425
Hospital Universitario Austral /ID# 241607
Pilar, Buenos Aires, 1629
Centro Respiratorio Infantil /ID# 241609
Rosario, Santa Fe Province, 2000
Australia6 sites
Flinders Medical Centre /ID# 242162
Bedford Park, South Australia, 5042
Sinclair Dermatology - Melbourne /ID# 242163
East Melbourne, Victoria, 3002
Kingsway Dermatology & Aesthetics /ID# 242276
Miranda, New South Wales, 2228
Sydney Skin /ID# 242277
Newtown, 2042
Burswood Dermatology /ID# 243767
Victoria Park, Western Australia, 6100
Veracity Clinical Research /ID# 242275
Woolloongabba, Queensland, 4102
Taiwan6 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 244758
Kaohsiung City, 807
Chung Shan Medical University Hospital /ID# 244757
Taichung, 402
Chang Gung Memorial Foundation-Taipei Branch /ID# 244760
Taipei, 05406
National Taiwan University Hospital /ID# 244754
Taipei, 100
Taipei Veterans General Hosp /ID# 244759
Taipei, 11217
Linkou Chang Gung Memorial Hospital /ID# 244756
Taoyuan City, 333
Austria5 sites
Ordensklinikum Linz Elisabethinen /ID# 246565
Linz, Upper Austria, 4010
Dr. Achim Schneeberger /ID# 247370
Nenzing, Vorarlberg, 6710
Medizin am Hauptbahnhof /ID# 246567
Vienna, State of Vienna, 1100
EZW HAUT Entzuendungszentrum Wien /ID# 246566
Vienna, State of Vienna, 1130
Klinikum Wels-Grieskirchen Gmbh /ID# 247369
Wels, Upper Austria, 4600
Czechia5 sites
Nemocnice Ceske Budejovice a.s. /ID# 246479
České Budějovice, 370 01
Fakultni nemocnice Olomouc /ID# 251177
Olomouc, 779 00
Fakultni nemocnice Bulovka /ID# 246482
Prague, Central Bohemia, 180 81
Fakultni nemocnice Motol a Homolka /ID# 246480
Prague, Praha 5, 150 06
Fakultni nemocnice Kralovske Vinohrady /ID# 250792
Prague, 100 34
Hungary5 sites
Semmelweis Egyetem /ID# 239948
Budapest, 1085
Debreceni Egyetem-Klinikai Kozpont /ID# 239949
Debrecen, Hajdú-Bihar, 4032
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 239950
Pécs, Baranya, 7624
Szegedi Tudomanyegyetem /ID# 239947
Szeged, Csongrád megye, 6720
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 239951
Szombathely, Vas County, 9700
Poland5 sites
Dermoklinika Medical Center /ID# 251249
Lodz, Łódź Voivodeship, 90-436
Luxderm Specjalistyczny Gabinet Dermatologiczny, /ID# 253106
Lublin, Lublin Voivodeship, 20-573
KSW nr1 w Rzeszowie /ID# 251251
Rzeszów, Podkarpackie Voivodeship, 35-055
Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 252447
Warsaw, Masovian Voivodeship, 02-507
Prywatna Praktyka Lekarska Witold Owczarek /ID# 252448
Warsaw, Masovian Voivodeship, 02-962
United Arab Emirates3 sites
New Medical Center Hospital /ID# 245106
Abu Dhabi
Tawam Hospital - Abu Dhabi /ID# 249696
Abu Dhabi
Safa Clinic /ID# 248492
Dubai
About this study
Official title: Real World Utilization of Upadacitinib in Adult and Adolescent Patients Living With Moderate to Severe Atopic Dermatitis (AD-VISE)
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.
Read more
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.
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Atopic Eczema, Upadacitinib, RINVOQ
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants Receiving Upadacitinib | Participants receiving upadacitinib for atopic dermatitis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Month 24
Secondary outcomes (55)
Modification of UPA or Concomitant AD Therapy and Associated Timing, Reasons
This includes UPA dose change, temporary or permanent discontinuation, switching, add or remove TCS.
Measured: Month 24
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75
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).
Measured: Up to Approximately 24 months
Percentage of Participants Achieving EASI 90
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).
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving EASI 100
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).
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving EASI <=1
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).
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving EASI <=5.9
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).
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving EASI <=7
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).
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving 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.
Measured: Up to Approximately 24 Months (Excluding Month 4 - Primary Outcome)
Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) 0/1
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.
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving WP-NRS <=3
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.
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving WP-NRS reduction >=4
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.
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving Patient Oriented Eczema Measurement (POEM) Score <=2
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.
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving POEM <=7
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
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving POEM Reduction >=4
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
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0/1
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.
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving DLQI Score <=5
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.
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving DLQI reduction >=4
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.
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving Atopic Dermatitis Control Tool (ADCT) <7 (control)
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.
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving ADCT reduction >=5
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.
Measured: Up to approximately 24 Months
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)
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).
Measured: Up to Approximately 24 Months
Percentage of Participants Remaining on Upadacitinib Once Daily
Percentage of participants remaining on upadacitinib once daily at all applicable time points.
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving EASI 75 Among Participants Who Achieved EASI 75 at Month 4
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).
Measured: Up to Approximately 24 months
Percentage of Participants Achieving EASI 90 Among Participants Who Achieved EASI 90 at Month 4
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).
Measured: Up to Approximately 24 months
Percentage of Participants Achieving EASI 100 Among Participants Who Achieved EASI 100 at Month 4
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).
Measured: Up to Approximately 24 months
Percentage of Participants Achieving vIGA-AD 0/1 Among Participants Who Achieved vIGA-AD 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.
Measured: Up to Approximately 24 Months (Excluding Month 24 - Primary Outcome)
Percentage of Participants Achieving WP-NRS 0/1 Among Participants Who Achieved WP-NRS 0/1 at Month 4
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.
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving DLQI Score of 0/1 Among Participants Achieving DLQI Score of 0/1 at Month 4
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.
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving ADCT Reduction <7 Among Participants Who Achieved ADCT Reduction <7 at Month 4
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.
Measured: Up to approximately 24 Months
Absolute Score and Change from Baseline in EASI
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).
Measured: Up to Approximately 24 months
Absolute Score and Change from Baseline in vIGA-AD
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.
Measured: Up to Approximately 24 months
Absolute Score and Change from Baseline in Body Surface Area (BSA)
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).
Measured: Up to Approximately 24 Months
Absolute Score and Change from Baseline in WP-NRS
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.
Measured: Up to Approximately 24 Months
Absolute Score and Change from Baseline in POEM
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.
Measured: Up to Approximately 24 Months
Absolute Score and Change from Baseline in DLQI
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.
Measured: Up to Approximately 24 Months
Absolute Score and Change from Baseline in ADCT
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.
Measured: Up to Approximately 24 months
Absolute Score and Change from Baseline in PGIT-AD
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).
Measured: Up to Approximately 24 Months
Change from Baseline in Flare Frequency and Duration
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.
Measured: Up to Approximately 24 Months
Change from Baseline in the Number of AD-Related Physician Office or Hospital Visits
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.
Measured: Up to Approximately 24 Months
Absolute Score and Change from Baseline in Work Productivity and Activity Impairment Index for Atopic Dermatitis (WPAI-AD)
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.
Measured: Up to Approximately 24 Months
Time to Achieve EASI 75
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).
Measured: Up to Approximately 24 months
Time to Achieve EASI 90
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).
Measured: Up to Approximately 24 months
Time to Achieve EASI 100
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).
Measured: Up to Approximately 24 months
Time to Achieve 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.
Measured: Up to Approximately 24 Months
Time to Achieve WP-NRS 0/1
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.
Measured: Up to Approximately 24 Months
Time to Achieve DLQI Score of 0/1
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.
Measured: Up to Approximately 24 Months
Time to Achieve POEM <=2
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.
Measured: Up to Approximately 24 Months
Time to Achieve ADCT <7
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.
Measured: Up to Approximately 24 Months
Time-Weighted EASI Score
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).
Measured: Up to Approximately 24 Months
Time-Weighted vIGA-AD Score
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.
Measured: Up to Approximately 24 Months
Time-Weighted WP-NRS Score
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.
Measured: Up to Approximately 24 Months
Time-Weighted DLQI Score
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.
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving Treatment Target EASI <8
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).
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving Treatment Target DLQI <=5
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.
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving Treatment Target WP-NRS <=4
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.
Measured: Up to Approximately 24 Months
Percentage of Participants Achieving Combined Treatment Targets of EASI <8, DLQI <=5, and WP-NRS <=4
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.
Measured: Up to Approximately 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start17 Nov 2021
- Primary completion2 Sep 2026
- Study completion2 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 873 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081557
- Sponsor's protocol ID
- P20-441
- Acronym
- ADVISE MCOS
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Utilization of Upadacitinib in Adult and Adolescent Patients Living With Moderate to Severe Atopic Dermatitis (AD-VISE)
- ClinicalTrials.gov ID
- NCT05081557
- Acronym / sponsor ID
- ADVISE MCOS / P20-441
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Atopic Eczema, Upadacitinib, RINVOQ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 873 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 2 Sep 2026 (actual)
- Study completion
- 2 Sep 2026 (actual)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving Upadacitinib | – | –Participants receiving upadacitinib for atopic dermatitis. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who are currently participating in interventional research (not including non-interventional study, post-marketing observational study, or registry participation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Upadacitinib (UPA) Utilization Patterns
Time frame: Up to Approximately 24 Months
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.
Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) 0/1
Time frame: 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.
vIGA-AD 0/1 Among Participants Who Achieved vIGA-AD 0/1 at Month 4
Time frame: Month 24
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.
55 secondary outcomes
Modification of UPA or Concomitant AD Therapy and Associated Timing, Reasons
Time frame: Month 24
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75
Time frame: Up to Approximately 24 months
Percentage of Participants Achieving EASI 90
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving EASI 100
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving EASI <=1
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving EASI <=5.9
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving EASI <=7
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving vIGA-AD 0/1
Time frame: Up to Approximately 24 Months (Excluding Month 4 - Primary Outcome)
Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) 0/1
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving WP-NRS <=3
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving WP-NRS reduction >=4
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving Patient Oriented Eczema Measurement (POEM) Score <=2
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving POEM <=7
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving POEM Reduction >=4
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0/1
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving DLQI Score <=5
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving DLQI reduction >=4
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving Atopic Dermatitis Control Tool (ADCT) <7 (control)
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving ADCT reduction >=5
Time frame: Up to approximately 24 Months
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)
Time frame: Up to Approximately 24 Months
Percentage of Participants Remaining on Upadacitinib Once Daily
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving EASI 75 Among Participants Who Achieved EASI 75 at Month 4
Time frame: Up to Approximately 24 months
Percentage of Participants Achieving EASI 90 Among Participants Who Achieved EASI 90 at Month 4
Time frame: Up to Approximately 24 months
Percentage of Participants Achieving EASI 100 Among Participants Who Achieved EASI 100 at Month 4
Time frame: Up to Approximately 24 months
Percentage of Participants Achieving vIGA-AD 0/1 Among Participants Who Achieved vIGA-AD at Month 4
Time frame: Up to Approximately 24 Months (Excluding Month 24 - Primary Outcome)
Percentage of Participants Achieving WP-NRS 0/1 Among Participants Who Achieved WP-NRS 0/1 at Month 4
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving DLQI Score of 0/1 Among Participants Achieving DLQI Score of 0/1 at Month 4
Time frame: Up to Approximately 24 Months
Percentage of Participants Achieving ADCT Reduction <7 Among Participants Who Achieved ADCT Reduction <7 at Month 4
Time frame: Up to approximately 24 Months
Absolute Score and Change from Baseline in EASI
Time frame: Up to Approximately 24 months
Absolute Score and Change from Baseline in vIGA-AD
Time frame: Up to Approximately 24 months
Absolute Score and Change from Baseline in Body Surface Area (BSA)
Time frame: Up to Approximately 24 Months
Absolute Score and Change from Baseline in WP-NRS
Time frame: Up to Approximately 24 Months
Absolute Score and Change from Baseline in POEM
Time frame: Up to Approximately 24 Months
Absolute Score and Change from Baseline in DLQI
Time frame: Up to Approximately 24 Months
Absolute Score and Change from Baseline in ADCT
Time frame: Up to Approximately 24 months
Absolute Score and Change from Baseline in PGIT-AD
Time frame: Up to Approximately 24 Months
Change from Baseline in Flare Frequency and Duration
Time frame: Up to Approximately 24 Months
Change from Baseline in the Number of AD-Related Physician Office or Hospital Visits
Time frame: Up to Approximately 24 Months
Absolute Score and Change from Baseline in Work Productivity and Activity Impairment Index for Atopic Dermatitis (WPAI-AD)
Time frame: Up to Approximately 24 Months
Time to Achieve EASI 75
Time frame: Up to Approximately 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
140 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by AbbVie at 140 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 140 sites in Canada, Spain, Mexico, Greece, Israel and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upadacitinib (UPA) Utilization Patterns (time frame: Up to Approximately 24 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.