Clinical Trial Details for

A Study to Assess Real-World Use, Safety, and Effectiveness of Oral Upadacitinib in Adult and Adolescent (>=12 Years Old) Participants With Atopic Dermatitis

NCT ID: NCT05081557

Last Updated: June 17, 2024

Official Title

Real World Utilization of Upadacitinib in Adult and Adolescent Patients Living With Moderate to Severe Atopic Dermatitis (AD-VISE)

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.

The Study at a Glance

Status: RECRUITING

Gender: ALL

Condition: Atopic Dermatitis

Study Type: Observational

Lead Sponsor: AbbVie

Eligibility

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

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).

Additional Information, Locations & Contacts

Collaborators: Not provided

Investigators: ABBVIE INC.

Please refer to this study by its clinicaltrials.gov identifier: NCT05081557
Location

Hospital Universitario Austral /ID# 241607

Pilar, Buenos Aires, Argentina

Buenos Aires Skin /ID# 241606

Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina

CEDIC Centro de Investigaciones Clinicas /ID# 241605

Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina

Instituto de Neumonologia y Dermatologia /ID# 241604

Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina

Centro Respiratorio Infantil /ID# 241609

Rosario, Santa Fe, Argentina

Hospital Italiano /ID# 241608

Caba, Argentina

Kingsway Dermatology & Aesthetics /ID# 242276

Miranda, New South Wales, Australia

Veracity Clinical Research /ID# 242275

Woolloongabba, Queensland, Australia

Flinders Medical Centre /ID# 242162

Bedford, Park, South Australia, Australia

Sinclair Dermatology - Melbourne /ID# 242163

East Melbourne, Victoria, Australia

Burswood Dermatology /ID# 243767

Victoria Park, Western Australia, Australia

Sydney Skin /ID# 242277

Newtown, Australia

Ordensklinikum Linz GmbH Elisabethinen /ID# 246565

Linz, Oberoesterreich, Austria

Klinikum Wels-Grieskirchen GmbH /ID# 247369

Wels, Oberoesterreich, Austria

Dr. Achim Schneeberger /ID# 247370

Nenzing, Vorarlberg, Austria

Medizin am Hauptbahnhof /ID# 246567

Vienna, Wien, Austria

EZW HAUT Entzuendungszentrum Wien /ID# 246566

Vienna, Wien, Austria

Rejuvenation Dermatology - Edmonton Downtown /ID# 240377

Edmonton, Alberta, Canada

Winnipeg Clinic /ID# 239603

Winnipeg, Manitoba, Canada

Dr. Irina Turchin PC Inc. /ID# 240358

Fredericton, New Brunswick, Canada

Karma Clinical Trials /ID# 239602

St. John's, Newfoundland and Labrador, Canada

NewLab Clinical Research Inc. /ID# 239600

St. John's, Newfoundland and Labrador, Canada

Dr Melinda Gooderham Medicine Profession /ID# 239745

Cobourg, Ontario, Canada

Lima's Excellence in Allergy and Dermatology Research Inc /ID# 239854

Hamilton, Ontario, Canada

Lynde Institute for Dermatology /ID# 240025

Markham, Ontario, Canada

Gordon Sussman Medicine Professional Corporation /ID# 243383

North York, Ontario, Canada

JRB Research /ID# 241862

Ottawa, Ontario, Canada

Dr. Michael Cecchini Medicine Professional Corporation /ID# 239605

Richmond Hill, Ontario, Canada

Dr. Lyne Giroux Medicine Professional Corporation /ID# 240084

Sudbury, Ontario, Canada

North York Research Inc /ID# 253191

Toronto, Ontario, Canada

Canadian Dermatology Centre /ID# 240585

Toronto, Ontario, Canada

Centricity Research - Toronto Dermatology /ID# 241019

Toronto, Ontario, Canada

Dr Maksym Breslavets Medicine Professional Corporation /ID# 239741

Whitby, Ontario, Canada

Clinique D /ID# 239601

Laval, Quebec, Canada

Roula Rassi MD Inc /ID# 252562

Laval, Quebec, Canada

Dre Angelique Gagne-Henley M.D. inc. /ID# 239604

Saint-Jerome, Quebec, Canada

Clinique de Dermatologie du Haut-Richelieu /ID# 239742

St-Jean Sur Le Richelieu, Quebec, Canada

Nemocnice Na Bulovce /ID# 246482

Prague, Stredocesky Kraj, Czechia

Nemocnice Ceske Budejovice a.s. /ID# 246479

Ceske Budejovice, Czechia

Fakultni nemocnice Olomouc /ID# 251177

Olomouc, Czechia

Duplicate_Fakultni Nemocnice v Motole /ID# 246480

Prague, Czechia

Fakultni nemocnice Kralovske Vinohrady /ID# 250792

Praha, Czechia

Olympion General Clinic /ID# 261694

Patras, Achaia, Greece

Hygeia Hospital /ID# 254188

Amaroussio, Attiki, Greece

401 GSNA - 401 Army General Hospital /ID# 253222

Athens, Attiki, Greece

401 GSNA - 401 Army General Hospital /ID# 253228

Athens, Attiki, Greece

University General Hospital Attikon /ID# 253221

Athens, Attiki, Greece

General Hospital Andreas Syggros /ID# 253220

Athens, Attiki, Greece

Tzaneio general hospital of Piraeus /ID# 253223

Piraeus, Attiki, Greece

Naval Hospital of Athens /ID# 253229

Athens, Greece

University General Hospital of Larissa /ID# 254216

Larissa, Greece

Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 253225

Thessaloniki, Greece

Papageorgiou General Hospital /ID# 253226

Thessaloniki, Greece

Debreceni Egyetem-Klinikai Kozpont /ID# 239949

Debrecen, Hajdu-Bihar, Hungary

Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 239951

Szombathely, Vas, Hungary

Semmelweis Egyetem /ID# 239948

Budapest, Hungary

Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 239950

Pecs, Hungary

Szegedi Tudományegyetem /ID# 239947

Szeged, Hungary

HaEmek Medical Center /ID# 247834

Afula, H_efa, Israel

Rambam Health Care Campus /ID# 244904

Haifa, H_efa, Israel

Maccabi /ID# 252598

Haifa, H_efa, Israel

The Edith Wolfson Medical Center /ID# 244902

Ashkelon, HaDarom, Israel

Duplicate_Kaplan Medical Center /ID# 244903

Rehovot, HaMerkaz, Israel

Leumit /ID# 260022

Rehovot, HaMerkaz, Israel

ZIV Medical Center /ID# 244908

Safed, HaTsafon, Israel

Sheba Medical Center /ID# 244905

Ramat Gan, Tel-Aviv, Israel

Tel Aviv Sourasky Medical Center /ID# 244907

Tel Aviv, Tel-Aviv, Israel

Shaare Zedek Medical Center /ID# 247833

Jerusalem, Yerushalayim, Israel

Ospedale Policlinico San Martino /ID# 255081

Genoa, Genova, Italy

Ospedale San Raffaele IRCCS /ID# 255285

Milan, Milano, Italy

AOU Citta della Salute e della Scienza di Torino /ID# 254615

Torino, Piemonte, Italy

Universita Campus Biomedico /ID# 255283

Rome, Roma, Italy

AOU San Giovanni e Ruggi Salerno - Presidio Ospedaliero S.M.I. dell'Olmo /ID# 254689

Cava De' Tirreni, Salerno, Italy

Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 254612

Bari, Italy

Presidio Ospedaliero Gaspare Rodolico /ID# 255707

Catania, Italy

AOU Gaetano Martino /ID# 255080

Messina, Italy

Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 254613

Novara, Italy

Azienda ULSS 8 Berica/Ospedale San Bortolo di Vicenza /ID# 255011

Vicenza, Italy

Centro de Investigacion Biologica y Terapia Avanzada SC (CIMBYTA) /ID# 243820

Guadalajara, Jalisco, Mexico

Centro Dermatologico Del Country S de Rl de Cv /Id# 243818

Guadalajara, Jalisco, Mexico

Grupo Clinico Catei Sociedad Civil /Id# 243809

Guadalajara, Jalisco, Mexico

Consultorio Medico Privado Alejandra Macias Weinmann /Id# 244159

Monterrey, Nuevo Leon, Mexico

Clinica Dermassad /Id# 264048

San Pedro Garza García, Nuevo Leon, Mexico

Consultorio Medico Privado Cipactli Ariel Navarro Hernandez /Id# 244165

Oaxaca de Juárez, Oaxaca, Mexico

Consultorio Medico Privado Yuri Igor Lopez Carrera /Id# 244164

San Andrés Cholula, Puebla, Mexico

Consultorio Privado Leslie Lourdes Rodriguez /Id# 243819

Mérida, Yucatan, Mexico

Consultorio Medico Privado Desiree Larenas Linnemann /Id# 244150

Ciudad de Mexico, Mexico

Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiova /ID# 243856

Mexico City, Mexico

Neki Servicios Medicos Profesionales S D Rl de Cv /Id# 243817

Toluca, Mexico

Dermoklinika Medical Center /ID# 251249

Lodz, Lodzkie, Poland

Luxderm Specjalistyczny Gabinet Dermatologiczny, /ID# 253106

Lublin, Lubelskie, Poland

Maciej Pastuszczak Indywidualna Praktyka Lekarska /ID# 253105

Cracow, Malopolskie, Poland

Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 252447

Warszawa, Mazowieckie, Poland

Prywatna Praktyka Lekarska Witold Owczarek /ID# 252448

Warszawa, Mazowieckie, Poland

KSW nr1 w Rzeszowie /ID# 251251

Rzeszow, Podkarpackie, Poland

Chelyabinsk Regional Clinical Dermatovenerologic Dispensary /ID# 248262

Chelyabinsk, Chelyabinskaya Oblast, Russian Federation

Clinical Dermatovenerology Dispensary /ID# 245225

Krasnodar, Krasnodarskiy Kray, Russian Federation

National Research Center " Institute of Immunology" of the FMBA of Russia /ID# 245221

Moscow, Moskva, Russian Federation

Research and Clinical Center for Hematology, Oncology and Immunology, Ryazan Sta /ID# 245220

Ryazan, Ryazanskaya Oblast, Russian Federation

LLC Scientific Medical Center for General Therapy and Pharmacology /ID# 245229

Stavropol, Stavropol Skiy Kray, Russian Federation

LLC "Medical Center ABC of Health" /ID# 244816

Kazan, Tatarstan, Respublika, Russian Federation

Republican hospital named after V.A. Baranov /ID# 245230

Petrozavodsk, Russian Federation

Hospital Universitario Germans Trias i Pujol /ID# 248512

Badalona, Barcelona, Spain

Hospital Universitari de Bellvitge /ID# 248513

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitari Mútua Terrassa /ID# 254292

Terrassa, Barcelona, Spain

Hospital San Pedro /ID# 248538

Logroño, La Rioja, Spain

Hospital Universitario Dr. Negrin /ID# 248533

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Santa María del Rosell /ID# 251956

Cartagena, Murcia, Spain

Hospital Universitario Canarias /ID# 251957

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

Hospital Universitario Basurto /ID# 248508

Bilbao, Vizcaya, Spain

Hospital Parc de Salut del Mar /ID# 258675

Barcelona, Spain

Hospital Santa Creu i Sant Pau /ID# 248511

Barcelona, Spain

Hospital Universitario Virgen de las Nieves /ID# 248528

Granada, Spain

Hospital Universitario Clinico San Cecilio /ID# 248530

Granada, Spain

Hospital Juan Ramon Jimenez /ID# 251960

Huelva, Spain

Hospital Universitario de Jaen /ID# 251959

Jaen, Spain

Hospital Universitario Lucus Augusti /ID# 248507

Lugo, Spain

Hospital Universitario Virgen de la Victoria /ID# 248531

Malaga, Spain

Hospital Universitario de Salamanca /ID# 253356

Salamanca, Spain

Hospital Universitario Nuestra Señora de Candelaria /ID# 251961

Santa Cruz de Tenerife, Spain

Hospital Universitario Virgen del Rocio /ID# 248527

Sevilla, Spain

Hospital Clinico Universitario de Valladolid /ID# 253355

Valladolid, Spain

Kantonsspital Aarau AG /ID# 245517

Aarau, Aargau, Switzerland

Dermatology & Skin Care Clinic /ID# 238348

Buochs, Nidwalden, Switzerland

Kantonsspital St. Gallen /ID# 239244

St. Gallen, Sankt Gallen, Switzerland

Haut- und Laserzentrum Weinfelden /ID# 239248

Weinfelden, Telangana, Switzerland

EOC Ospedale Regionale di Bellinzona e Valli /ID# 239246

Bellinzona, Ticino, Switzerland

Basile Darbellay SA /ID# 239245

Orsières, Valais, Switzerland

University Hospital Zurich /ID# 240076

Zurich, Zuerich, Switzerland

National Taiwan University Hospital /ID# 244754

Taipei City, Taipei, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 244758

Kaohsiung, Taiwan

Chung Shan Medical University Hospital /ID# 244757

Taichung, Taiwan

Chang Gung Memorial Foundation-Taipei Branch /ID# 244760

Taipei City, Taiwan

Taipei Veterans General Hosp /ID# 244759

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital /ID# 244756

Taoyuan City, Taiwan

New Medical Center Hospital /ID# 245106

Abu Dhabi, United Arab Emirates

Tawam Hospital /ID# 249696

Abu Dhabi, United Arab Emirates

Safa Clinic /ID# 248492

Dubai, United Arab Emirates

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