A Study to Assess Disease Activity in Adolescent and Adult Participants With Atopic Dermatitis Who Receive Oral Upadacitinib Tablets in a Real-World Setting
Study Purpose
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study will assess the real-world effectiveness of upadacitinib on early and sustained response along adolescent and adult participants with AD. This study also aims to understand upadacitinib utilization patterns in real-world clinical practice. Upadacitinib (RINVOQ) is approved in the EU for the treatment of moderate to severe AD in adults and adolescents 12 years and older who are candidates for systemic therapy. Approximately 772 adolescent and adult participants with AD will be enrolled at up to 200 sites in Germany. Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population, and indication. The overall duration of the study is approximately 2 years. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.
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:
- - Body weight >=30 kg at baseline for participants between >=12 and <18 years of age.
- - Physician confirmed diagnosis of moderate to severe atopic dermatitis at the time of enrollment.
- - Upadacitinib initiated as per the local label.
- - Medical and medication history available at least for the last 6 months.
Exclusion Criteria:
- - Current participation in interventional research (note: this does not include non-interventional, post-marketing observational studies, 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. |
NCT05139836 |
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 | Germany |
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 moderate to severe 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
Recruiting
Address
Universitaetsklinik Heidelberg /ID# 245834
Heidelberg, Baden-Wuerttemberg, 69120
Status
Recruiting
Address
Praxis Dr. Behnke /ID# 248870
Panketal, Brandenburg, 16341
Status
Recruiting
Address
Praxis Dr. Asadullah /ID# 243944
Potsdam, Brandenburg, 14467
Status
Recruiting
Address
Hautärzte am Nauener Tor /ID# 261533
Potsdam, Brandenburg, 14469
Status
Recruiting
Address
Universitaetsklinikum Frankfurt /ID# 241766
Frankfurt am Main, Hessen, 60590
Status
Recruiting
Address
CMS3 Company for Medical Study /ID# 241659
Selters, Rheinland-Pfalz, 56242
Status
Recruiting
Address
HMS GmbH Zimmer /ID# 241657
Merzig, Saarland, 66663
Status
Recruiting
Address
Praxis Dr. Mempel /ID# 241827
Elmshorn, Schleswig-Holstein, 25335
Status
Recruiting
Address
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 240096
Kiel, Schleswig-Holstein, 24105
Status
Recruiting
Address
Dermatologie Moelln Praxis Dr. Bodo Segert /ID# 242280
Mölln, Schleswig-Holstein, 23879
Status
Recruiting
Address
Hoeller-Obrigkeit, Aachen, DE /ID# 245430
Aachen, , 52064
Status
Recruiting
Address
Petri, Ahaus, DE /ID# 243452
Ahaus, , 48683
Status
Recruiting
Address
Dr. Stoeber /ID# 251066
Ahlen, , 59227
Status
Recruiting
Address
Bell, Andernach, DE /ID# 249154
Andernach, , 56626
Status
Recruiting
Address
Praxis Dr. Mihaescu /ID# 241825
Augsburg, , 86150
Status
Recruiting
Address
Mauer, Bad Kreuznach, DE /ID# 241990
Bad Kreuznach, , 55543
Status
Recruiting
Address
Timmel/Timm/Vorwerk, Bergen /ID# 241661
Bergen, , 18528
Status
Recruiting
Address
Hautarztpraxis Dr. med. Christiane Handrick /ID# 262667
Berlin, , 10117
Status
Recruiting
Address
Praxis Dermatologie am Savigny /ID# 248846
Berlin, , 10623
Status
Recruiting
Address
Dre. Gellrich/Klein/Soost /ID# 250301
Berlin, , 12247
Status
Recruiting
Address
Schirmer, Berlin, DE /ID# 241684
Berlin, , 12489
Status
Recruiting
Address
Kors, Berlin, DE /ID# 241847
Berlin, , 13086
Status
Recruiting
Address
Dues/Manasterski, Berlin, DE /ID# 243885
Berlin, , 13507
Status
Recruiting
Address
Hautarztzentrum Tegel /ID# 241826
Berlin, , 13507
Status
Recruiting
Address
Haut Pur - Dermatologische Gemeinschaftspraxis /ID# 243943
Berlin, , 13597
Status
Recruiting
Address
Klinikum Rosenhoehe /ID# 241601
Bielefeld, , 33647
Status
Recruiting
Address
Praxis fuer Innere Medizin/Rheumatologie /ID# 241846
Blaubeuren, , 89143
Status
Recruiting
Address
Praxis T. Schadeck /ID# 241768
Bogen, , 94327
Status
Recruiting
Address
Barth, Borna, DE /ID# 248871
Borna, , 04552
Status
Recruiting
Address
Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 241658
Bramsche, , 49565
Status
Recruiting
Address
Schwichtenberg, Bremen, DE /ID# 241683
Bremen, , 28779
Status
Recruiting
Address
Praxis P. Hausler-Mehlhorn /ID# 241527
Chemnitz, , 09130
Status
Recruiting
Address
Dr. Hoffmann /ID# 245423
Cologne, , 50674
Status
Recruiting
Address
Derma Köln /ID# 241856
Cologne, , 50737
Status
Recruiting
Address
Praxis Dr. Sbornik /ID# 241818
Deggendorf, , 94469
Status
Recruiting
Address
Hautmedizin Delitzsch /ID# 251394
Delitzsch, , 04509
Status
Recruiting
Address
Richter-Huhn, Dresden, DE /ID# 241822
Dresden, , 01219
Status
Recruiting
Address
Praxis Dr. Korge /ID# 241531
Dueren, , 52349
Status
Recruiting
Address
Praxis Dres. Freitag/Knoell /ID# 242278
Falkensee, , 14612
Status
Recruiting
Address
Praxis Dr. Hong-Weldemann /ID# 248844
Freiburg im Breisgau, , 79098
Status
Recruiting
Address
Kurzen, Freising, DE /ID# 241845
Freising, , 85354
Status
Recruiting
Address
Hautarztpraxis Friedberg Dr. med. Wilfried Jungkunz /ID# 248851
Friedberg (Hessen), , 61169
Status
Recruiting
Address
Rotterdam, Gelsenkirchen, DE /ID# 241819
Gelsenkirchen, , 45897
Status
Recruiting
Address
Gemeinschaftspraxis Rietkoetter und Jablonka /ID# 241821
Gelsenkirchen, , 45899
Status
Recruiting
Address
Praxis Dr. Lange /ID# 241829
Gera, , 07548
Status
Recruiting
Address
Loth, Gernsbach, DE /ID# 241828
Gernsbach, , 76593
Status
Recruiting
Address
Hautarztpraxis Dr. Budihardja /ID# 241851
Gießen, , 35392
Status
Recruiting
Address
Brinkmann & Partner, Gladbeck, /ID# 241850
Gladbeck, , 45964
Status
Recruiting
Address
Dr. Krueger /ID# 265150
Goslar, , 38640
Status
Recruiting
Address
Herrmann, Greifswald, DE /ID# 241889
Greifswald, , 17489
Status
Recruiting
Address
Grossmann, Grossenhain, DE /ID# 250303
Grossenhain, , 01558
Status
Recruiting
Address
Praxis Dr. Wegener /ID# 263731
Hamburg, , 20095
Status
Recruiting
Address
Cutaneum /ID# 249104
Hamburg, , 20249
Status
Recruiting
Address
Dermatologikum Hamburg GmbH /ID# 245431
Hamburg, , 20354
Status
Recruiting
Address
Hautarztpraxis Luetten/Sack /ID# 241534
Hamburg, , 21109
Status
Recruiting
Address
Praxis Dr. Kasche /ID# 249102
Hamburg, , 22549
Status
Recruiting
Address
MVZ Prof. Dr. Ockenfels Haut- und Allergie-Praxisklinik GmbH /ID# 245395
Hanau, , 63450
Status
Recruiting
Address
Praxis Dres. Kaspari /Schenck /ID# 241688
Hannover, , 30159
Status
Recruiting
Address
Dr. Buerkle /ID# 250299
Haslach im Kinzigtal, , 77716
Status
Recruiting
Address
Hautarztpraxis Haßberge /ID# 257648
Haßfurt, , 97437
Status
Recruiting
Address
Durani & Durani, Heidelberg,DE /ID# 249172
Heidelberg, , 69115
Status
Recruiting
Address
Gemeinschaftspraxis Dres. Anika Hünermund/Mario Pawlak /ID# 241908
Heilbad Heiligenstadt, , 37308
Status
Recruiting
Address
Haut- u. Laserzentrum Heilbronn /ID# 250305
Heilbronn, , 74072
Status
Recruiting
Address
Hausarztpraxis & Laserzentrum Dr. Zimmermann & Kollegen /ID# 251051
Heusenstamm, , 63150
Status
Recruiting
Address
Praxis Dres. Bischoff/Danz /ID# 241852
Ilmenau, , 98693
Status
Recruiting
Address
Stockmeier, Ingoldstadt, DE /ID# 248877
Ingolstadt, , 85049
Status
Recruiting
Address
Hautarztpraxis Weidgang /ID# 248850
Juelich, , 52428
Status
Recruiting
Address
Derma Sana /ID# 241854
Karlsruhe, , 76133
Status
Recruiting
Address
Dermatologische Praxis Kempen /ID# 248852
Kempen, , 47906
Status
Recruiting
Address
Grossmann, Koblenz, DE /ID# 242992
Koblenz, , 56068
Status
Recruiting
Address
Praxis Dres. Bornemann/Reinerth /ID# 257649
Krefeld, , 47798
Status
Recruiting
Address
Dres. Jacobs & Kollegen /ID# 241989
Kulmbach, , 95326
Status
Recruiting
Address
Hautarztpraxis Langenau /ID# 242279
Langenau, , 89129
Status
Recruiting
Address
Neubauer, Leipzig, DE /ID# 241823
Leipzig, , 04209
Status
Recruiting
Address
Praxis Dres. Wiemers/Wiemers /ID# 241602
Leipzig, , 04317
Status
Recruiting
Address
Haut- und Allergie-Zentrum Lippstadt /ID# 241929
Lippstadt, , 59557
Status
Completed
Address
Hagemeier, Loehne, DE /ID# 241886
Loehne, , 32584
Status
Recruiting
Address
Magdeburger Company for Medical Studies & Services GmbH /ID# 248849
Magdeburg, , 39104
Status
Recruiting
Address
MVZ "Im Altstadtquartier" Magdeburg /ID# 261366
Magdeburg, , 39104
Status
Recruiting
Address
Praxis Dr. Raschke /ID# 251398
Magdeburg, , 39104
Status
Recruiting
Address
Universitaetsklinikum Magdeburg /ID# 249174
Magdeburg, , 39120
Status
Recruiting
Address
Hausärzte am Fastnachtsbrunnen /ID# 250304
Mainz, , 55116
Status
Recruiting
Address
Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 243325
Mainz, , 55128
Status
Recruiting
Address
Beldio Research GmbH /ID# 245830
Memmingen, , 87700
Status
Recruiting
Address
Praxis A. Viculova /ID# 266133
Miltenberg, , 63897
Status
Recruiting
Address
Hautzentrum am Marienplatz /ID# 248847
Munich, , 80331
Status
Recruiting
Address
Quack, Munich, DE /ID# 241536
Munich, , 81539
Status
Recruiting
Address
Dr. Gißler-Walter /ID# 248876
Mutterstadt, , 67112
Status
Recruiting
Address
ZENTderma /ID# 241539
Mönchengladbach, , 41061
Status
Recruiting
Address
Dr. Rezai /ID# 250298
Münster, , 48143
Status
Recruiting
Address
Dermatologie im Apfelgarten /ID# 263704
Neu Wulmstorf, , 21629
Status
Recruiting
Address
Praxis Dr. Konstantin Ertner /ID# 249153
Nuremberg, , 90402
Status
Recruiting
Address
Voelkel, Nuremberg, DE /ID# 252445
Nuremberg, , 90419
Status
Recruiting
Address
MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 243328
Oberursel, , 61440
Status
Recruiting
Address
Hockmann, Oelde, DE /ID# 241906
Oelde, , 59302
Status
Recruiting
Address
Harzklinikum Dorothea Christiane Erxleben /ID# 251067
Quedlinburg, , 06484
Status
Recruiting
Address
Kramer/Mortazawi, Remscheid /ID# 241824
Remscheid, , 42897
Status
Recruiting
Address
Dr. Schaefers /ID# 255492
Reutlingen, , 72764
Status
Recruiting
Address
Praxis Dr. Fränken /ID# 241853
Schwelm, , 58332
Status
Recruiting
Address
Haut- und Laserzentrum Hunsrück /ID# 243882
Simmern, , 55469
Status
Recruiting
Address
Karl, Soest, DE /ID# 241909
Soest, , 59494
Status
Completed
Address
Gemeinschaftspraxis fur Dermatologie /ID# 245831
Stadtroda, , 07646
Status
Active, not recruiting
Address
Praxis Dr. Termeer /ID# 241662
Stuttgart, , 70499
Status
Recruiting
Address
Flegl MD Stuttgart Germany /ID# 250302
Stuttgart, , 70567
Status
Recruiting
Address
Jasnoch/Kock/Borrosch, Vechta, /ID# 252081
Vechta, , 49377
Status
Recruiting
Address
Barnikol, Waltershausen, DE /ID# 241844
Waltershausen, , 99880
Status
Recruiting
Address
Praxis Dehmel / Brand-Opitzer /ID# 243884
Wasserburg A. Inn, , 83512
Status
Recruiting
Address
Dr. Barbara Kempkes, Werne /ID# 241910
Werne, , 59368
Status
Recruiting
Address
Dr. med. Nicola Möller & Thomas Kurtenbach GbR Dermatologie im Zentrum /ID# 266130
Wiesbaden, , 65185
Status
Recruiting
Address
Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 241907
Witten, , 58453
Status
Recruiting
Address
Albrecht, Wurzen, DE /ID# 241988
Wurzen, , 04808