A Study to Assess Real-World Use, Safety, and Effectiveness of Oral Upadacitinib in Adult and Adolescent (>=12 Years Old) Participants With Atopic Dermatitis
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
Eligible Ages | 12 Years and Over |
Gender | All |
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.
Exclusion Criteria:
- - Participants who are currently participating in interventional research (not including non-interventional study, post-marketing observational study, or registry participation).
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05081557 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
AbbVie |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
ABBVIE INC. |
Principal Investigator Affiliation | AbbVie |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Australia, Austria, Canada, Czechia, Greece, Hungary, Israel, Italy, Mexico, Poland, Russian Federation, Spain, Switzerland, Taiwan, United Arab Emirates |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Atopic Dermatitis |
Study Website: | View Trial Website |
Arms
: Participants Receiving Upadacitinib
Participants receiving upadacitinib for atopic dermatitis.
Interventions
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Active, not recruiting
Address
Hospital Universitario Austral /ID# 241607
Pilar, Buenos Aires, 1629
Status
Active, not recruiting
Address
Buenos Aires Skin /ID# 241606
Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, 1055
Status
Active, not recruiting
Address
CEDIC Centro de Investigaciones Clinicas /ID# 241605
Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, 1425
Status
Active, not recruiting
Address
Instituto de Neumonología y Dermatología /ID# 241604
Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, 1425
Status
Active, not recruiting
Address
Centro Respiratorio Infantil /ID# 241609
Rosario, Santa Fe, 2000
Status
Active, not recruiting
Address
Hospital Italiano /ID# 241608
Caba, , C1199ABB
Status
Recruiting
Address
Kingsway Dermatology & Aesthetics /ID# 242276
Miranda, New South Wales, 2228
Status
Recruiting
Address
Veracity Clinical Research /ID# 242275
Woolloongabba, Queensland, 4102
Status
Recruiting
Address
Flinders Medical Centre /ID# 242162
Bedford, Park, South Australia, 5042
Status
Recruiting
Address
Sinclair Dermatology - Melbourne /ID# 242163
East Melbourne, Victoria, 3002
Status
Recruiting
Address
Burswood Dermatology /ID# 243767
Victoria Park, Western Australia, 6100
Status
Recruiting
Address
Sydney Skin /ID# 242277
Newtown, , 2042
Status
Recruiting
Address
Ordensklinikum Linz GmbH Elisabethinen /ID# 246565
Linz, Oberoesterreich, 4010
Status
Recruiting
Address
Klinikum Wels-Grieskirchen GmbH /ID# 247369
Wels, Oberoesterreich, 4600
Status
Recruiting
Address
Dr. Achim Schneeberger /ID# 247370
Nenzing, Vorarlberg, 6710
Status
Recruiting
Address
Medizin am Hauptbahnhof /ID# 246567
Vienna, Wien, 1100
Status
Recruiting
Address
EZW HAUT Entzuendungszentrum Wien /ID# 246566
Vienna, Wien, 1130
Status
Active, not recruiting
Address
Rejuvenation Dermatology - Edmonton Downtown /ID# 240377
Edmonton, Alberta, T5J 3S9
Status
Active, not recruiting
Address
Winnipeg Clinic /ID# 239603
Winnipeg, Manitoba, R3C 0N2
Status
Active, not recruiting
Address
Dr. Irina Turchin PC Inc. /ID# 240358
Fredericton, New Brunswick, E3B 1G9
Status
Active, not recruiting
Address
Karma Clinical Trials /ID# 239602
St. John's, Newfoundland and Labrador, A1A 4Y3
Status
Completed
Address
NewLab Clinical Research Inc. /ID# 239600
St. John's, Newfoundland and Labrador, A1C 2H5
Status
Active, not recruiting
Address
Dr Melinda Gooderham Medicine Profession /ID# 239745
Cobourg, Ontario, K9A 0Z4
Status
Active, not recruiting
Address
Lima's Excellence in Allergy and Dermatology Research Inc /ID# 239854
Hamilton, Ontario, L8L 3C3
Status
Active, not recruiting
Address
Lynde Institute for Dermatology /ID# 240025
Markham, Ontario, L3P 1X2
Status
Completed
Address
Gordon Sussman Medicine Professional Corporation /ID# 243383
North York, Ontario, M3B 3S6
Status
Active, not recruiting
Address
JRB Research /ID# 241862
Ottawa, Ontario, K1H 7X3
Status
Active, not recruiting
Address
York Dermatology Clinic and Research Centre /ID# 239605
Richmond Hill, Ontario, L4C 9M7
Status
Active, not recruiting
Address
Dr. Lyne Giroux Medicine Professional Corporation /ID# 240084
Sudbury, Ontario, P3C 1X3
Status
Active, not recruiting
Address
North York Research Inc /ID# 253191
Toronto, Ontario, M2N 3A6
Status
Active, not recruiting
Address
Canadian Dermatology Centre /ID# 240585
Toronto, Ontario, M3B 0A7
Status
Completed
Address
Centricity Research - Toronto Dermatology /ID# 241019
Toronto, Ontario, M4C 1L1
Status
Active, not recruiting
Address
Dr Maksym Breslavets Medicine Professional Corporation /ID# 239741
Whitby, Ontario, L1N 8M7
Status
Recruiting
Address
Clinique D /ID# 239601
Laval, Quebec, H7N 6L2
Status
Completed
Address
Roula Rassi MD Inc /ID# 252562
Laval, Quebec, H7P 4K7
Status
Active, not recruiting
Address
Dre Angelique Gagne-Henley M.D. inc. /ID# 239604
Saint-Jerome, Quebec, J7Z 7E2
Status
Active, not recruiting
Address
Clinique de Dermatologie du Haut-Richelieu /ID# 239742
St-Jean Sur Le Richelieu, Quebec, J3A 1B5
Status
Recruiting
Address
Nemocnice Ceske Budejovice a.s. /ID# 246479
Ceske Budejovice, , 370 01
Status
Recruiting
Address
Fakultni nemocnice Olomouc /ID# 251177
Olomouc, , 779 00
Status
Recruiting
Address
Duplicate_Fakultni Nemocnice v Motole /ID# 246480
Prague, , 150 00
Status
Recruiting
Address
Fakultni nemocnice Kralovske Vinohrady /ID# 250792
Praha, , 100 34
Status
Recruiting
Address
Fakultní nemocnice Bulovka /ID# 246482
Praha, , 180 81
Status
Recruiting
Address
Hygeia Hospital /ID# 254188
Amaroussio, Attiki, 15123
Status
Recruiting
Address
401 GSNA - 401 Army General Hospital /ID# 253222
Athens, Attiki, 11527
Status
Recruiting
Address
401 GSNA - 401 Army General Hospital /ID# 253228
Athens, Attiki, 11527
Status
Recruiting
Address
University General Hospital Attikon /ID# 253221
Athens, Attiki, 12462
Status
Recruiting
Address
General Hospital Andreas Syggros /ID# 253220
Athens, Attiki, 16121
Status
Recruiting
Address
Naval Hospital of Athens /ID# 253229
Athens, , 11521
Status
Recruiting
Address
University General Hospital of Larissa /ID# 254216
Larissa, , 41110
Status
Recruiting
Address
Olympion General Clinic SA /ID# 261694
Patras, , 26443
Status
Recruiting
Address
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 253225
Thessaloniki, , 54643
Status
Recruiting
Address
Papageorgiou General Hospital /ID# 253226
Thessaloniki, , 56429
Status
Active, not recruiting
Address
Debreceni Egyetem-Klinikai Kozpont /ID# 239949
Debrecen, Hajdu-Bihar, 4032
Status
Active, not recruiting
Address
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 239951
Szombathely, Vas, 9700
Status
Active, not recruiting
Address
Semmelweis Egyetem /ID# 239948
Budapest, , 1085
Status
Active, not recruiting
Address
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 239950
Pecs, , 7624
Status
Recruiting
Address
Szegedi Tudományegyetem /ID# 239947
Szeged, , 6720
Status
Recruiting
Address
Rambam Health Care Campus /ID# 244904
Haifa, H_efa, 3109601
Status
Recruiting
Address
Maccabi /ID# 252598
Haifa, H_efa, 7176250
Status
Recruiting
Address
The Edith Wolfson Medical Center /ID# 244902
Ashkelon, HaDarom, 5822000
Status
Completed
Address
Kaplan Medical Center /ID# 244903
Rehovot, HaMerkaz, 7661041
Status
Recruiting
Address
Leumit /ID# 260022
Rehovot, HaMerkaz, 9458414
Status
Recruiting
Address
ZIV Medical Center /ID# 244908
Safed, HaTsafon, 13100
Status
Recruiting
Address
Sheba Medical Center /ID# 244905
Ramat Gan, Tel-Aviv, 52621
Status
Recruiting
Address
Tel Aviv Sourasky Medical Center /ID# 244907
Tel Aviv, Tel-Aviv, 6423906
Status
Completed
Address
Shaare Zedek Medical Center /ID# 247833
Jerusalem, Yerushalayim, 91031
Status
Recruiting
Address
Clalit Health Services - Emek Medical Center /ID# 247834
Afula, , 1834111
Status
Recruiting
Address
Ospedale San Raffaele IRCCS /ID# 255285
Milan, Milano, 20132
Status
Recruiting
Address
AOU Citta della Salute e della Scienza di Torino /ID# 254615
Torino, Piemonte, 10126
Status
Recruiting
Address
Universita Campus Biomedico /ID# 255283
Rome, Roma, 00128
Status
Recruiting
Address
AOU San Giovanni e Ruggi Salerno - Presidio Ospedaliero S.M.I. dell'Olmo /ID# 254689
Cava De' Tirreni, Salerno, 84013
Status
Recruiting
Address
Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 254612
Bari, , 70124
Status
Recruiting
Address
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 255707
Catania, , 95123
Status
Recruiting
Address
AOU Gaetano Martino /ID# 255080
Messina, , 98122
Status
Recruiting
Address
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 254613
Novara, , 28100
Status
Recruiting
Address
Azienda ULSS 8 Berica/Ospedale San Bortolo di Vicenza /ID# 255011
Vicenza, , 36100
Status
Recruiting
Address
Centro de Investigacion Biologica y Terapia Avanzada SC (CIMBYTA) /ID# 243820
Guadalajara, Jalisco, 44130
Status
Recruiting
Address
Centro Dermatologico Del Country S de Rl de Cv /Id# 243818
Guadalajara, Jalisco, 44610
Status
Recruiting
Address
Grupo Clinico Catei Sociedad Civil /Id# 243809
Guadalajara, Jalisco, 44657
Status
Recruiting
Address
Consultorio Medico Privado Alejandra Macias Weinmann /Id# 244159
Monterrey, Nuevo Leon, 64623
Status
Recruiting
Address
Clinica Dermassad /Id# 264048
San Pedro Garza García, Nuevo Leon, 66220
Status
Recruiting
Address
Consultorio Medico Privado Cipactli Ariel Navarro Hernandez /Id# 244165
Oaxaca de Juárez, Oaxaca, 68000
Status
Recruiting
Address
Consultorio Medico Privado Yuri Igor Lopez Carrera /Id# 244164
San Andrés Cholula, Puebla, 72820
Status
Recruiting
Address
Consultorio Privado Leslie Lourdes Rodriguez /Id# 243819
Mérida, Yucatan, 97203
Status
Recruiting
Address
Consultorio Medico Privado Desiree Larenas Linnemann /Id# 244150
Ciudad de Mexico, , 14050
Status
Recruiting
Address
Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiova /ID# 243856
Mexico City, , 11650
Status
Recruiting
Address
Neki Servicios Medicos Profesionales S D Rl de Cv /Id# 243817
Toluca, , 50120
Status
Recruiting
Address
Dermoklinika Medical Center /ID# 251249
Lodz, Lodzkie, 90-436
Status
Active, not recruiting
Address
Luxderm Specjalistyczny Gabinet Dermatologiczny, /ID# 253106
Lublin, Lubelskie, 20-573
Status
Recruiting
Address
Maciej Pastuszczak Indywidualna Praktyka Lekarska /ID# 253105
Cracow, Malopolskie, 30-383
Status
Recruiting
Address
Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 252447
Warszawa, Mazowieckie, 02-507
Status
Active, not recruiting
Address
Prywatna Praktyka Lekarska Witold Owczarek /ID# 252448
Warszawa, Mazowieckie, 02-962
Status
Recruiting
Address
KSW nr1 w Rzeszowie /ID# 251251
Rzeszow, Podkarpackie, 35-055
Status
Active, not recruiting
Address
Chelyabinsk Regional Clinical Dermatovenerologic Dispensary /ID# 248262
Chelyabinsk, Chelyabinskaya Oblast, 454048
Status
Active, not recruiting
Address
Clinical Dermatovenerology Dispensary /ID# 245225
Krasnodar, Krasnodarskiy Kray, 350020
Status
Active, not recruiting
Address
National Research Center " Institute of Immunology" of the FMBA of Russia /ID# 245221
Moscow, Moskva, 115522
Status
Active, not recruiting
Address
Research and Clinical Center for Hematology, Oncology and Immunology, Ryazan Sta /ID# 245220
Ryazan, Ryazanskaya Oblast, 390029
Status
Active, not recruiting
Address
LLC Scientific Medical Center for General Therapy and Pharmacology /ID# 245229
Stavropol, Stavropol Skiy Kray, 355000
Status
Active, not recruiting
Address
LLC "Medical Center ABC of Health" /ID# 244816
Kazan, Tatarstan, Respublika, 420111
Status
Active, not recruiting
Address
Republican hospital named after V.A. Baranov /ID# 245230
Petrozavodsk, , 185019
Status
Recruiting
Address
Hospital Universitario Germans Trias i Pujol /ID# 248512
Badalona, Barcelona, 08916
Status
Recruiting
Address
Hospital Universitari de Bellvitge /ID# 248513
L'Hospitalet de Llobregat, Barcelona, 08907
Status
Recruiting
Address
Hospital Universitari Mútua Terrassa /ID# 254292
Terrassa, Barcelona, 08221
Status
Recruiting
Address
Hospital San Pedro /ID# 248538
Logroño, La Rioja, 26006
Status
Recruiting
Address
Hospital Universitario Dr. Negrin /ID# 248533
Las Palmas de Gran Canaria, Las Palmas, 35019
Status
Recruiting
Address
Hospital Santa María del Rosell /ID# 251956
Cartagena, Murcia, 30203
Status
Recruiting
Address
Hospital Universitario Canarias /ID# 251957
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Status
Recruiting
Address
Hospital Universitario Basurto /ID# 248508
Bilbao, Vizcaya, 48013
Status
Recruiting
Address
Hospital Parc de Salut del Mar /ID# 258675
Barcelona, , 08003
Status
Recruiting
Address
Hospital Santa Creu i Sant Pau /ID# 248511
Barcelona, , 08041
Status
Recruiting
Address
Hospital Universitario Virgen de las Nieves /ID# 248528
Granada, , 18014
Status
Recruiting
Address
Hospital Universitario Clinico San Cecilio /ID# 248530
Granada, , 18016
Status
Recruiting
Address
Hospital Juan Ramon Jimenez /ID# 251960
Huelva, , 21005
Status
Completed
Address
Hospital Universitario de Jaen /ID# 251959
Jaen, , 23007
Status
Recruiting
Address
Hospital Universitario Lucus Augusti /ID# 248507
Lugo, , 27003
Status
Recruiting
Address
Hospital Universitario Virgen de la Victoria /ID# 248531
Malaga, , 29010
Status
Recruiting
Address
Hospital Universitario de Salamanca /ID# 253356
Salamanca, , 37711
Status
Recruiting
Address
Hospital Universitario Nuestra Señora de Candelaria /ID# 251961
Santa Cruz de Tenerife, , 38010
Status
Recruiting
Address
Hospital Universitario Virgen del Rocio /ID# 248527
Sevilla, , 41013
Status
Recruiting
Address
Hospital Clinico Universitario de Valladolid /ID# 253355
Valladolid, , 47003
Status
Recruiting
Address
Kantonsspital Aarau AG /ID# 245517
Aarau, Aargau, 5001
Status
Recruiting
Address
Dermatology & Skin Care Clinic /ID# 238348
Buochs, Nidwalden, 6374
Status
Recruiting
Address
Kantonsspital St. Gallen /ID# 239244
St. Gallen, Sankt Gallen, 9007
Status
Recruiting
Address
Haut- und Laserzentrum Weinfelden /ID# 239248
Weinfelden, Telangana, 8570
Status
Recruiting
Address
EOC Ospedale Regionale di Bellinzona e Valli /ID# 239246
Bellinzona, Ticino, 6500
Status
Recruiting
Address
Basile Darbellay SA /ID# 239245
Orsières, Valais, 1937
Status
Recruiting
Address
University Hospital Zurich /ID# 240076
Zürich, , 8091
Status
Recruiting
Address
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 244758
Kaohsiung, , 807
Status
Recruiting
Address
Chung Shan Medical University Hospital /ID# 244757
Taichung, , 40201
Status
Recruiting
Address
Chang Gung Memorial Foundation-Taipei Branch /ID# 244760
Taipei City, , 05406
Status
Recruiting
Address
National Taiwan University Hospital /ID# 244754
Taipei City, , 100
Status
Recruiting
Address
Taipei Veterans General Hosp /ID# 244759
Taipei, , 11217
Status
Recruiting
Address
Linkou Chang Gung Memorial Hospital /ID# 244756
Taoyuan City, , 333
Status
Recruiting
Address
New Medical Center Hospital /ID# 245106
Abu Dhabi, ,