A Study to Assess Disease Activity in Adolescent and Adult Participants With Atopic Dermatitis Who Receive Oral Upadacitinib Tablets in a Real-World Setting
UP-TAINED
Non-Interventional, Prospective Observational Cohort Study to Investigate the Effectiveness and Sustained Disease Control of an Upadacitinib Therapy in Moderate to Severe Atopic Dermatitis Patients Over Two Years
1 other identifier
observational
634
1 country
125
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Longer than P75 for all trials
125 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2021
CompletedFirst Posted
Study publicly available on registry
December 1, 2021
CompletedStudy Start
First participant enrolled
December 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
January 26, 2026
January 1, 2026
5.7 years
November 29, 2021
January 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving Disease Control Defined by Atopic Dermatitis Control Tool (ADCT) Total Score <7 Points
The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of \>=7 indicates that the patient is not in control.
Month 3
Percentage of Participants Achieving Disease Control Defined by ADCT Total Score <7 Points Among Participants Who Achieved Disease Control at Month 3
The ADCT is a validated patient self-administered instrument designed to assess atopic dermatitis (AD) control status in adult and adolescent patients (12 years and older). A higher score indicates lower AD control. A score of \>=7 indicates that the patient is not in control.
Month 24
Secondary Outcomes (87)
Percentage of Participants Achieving Disease Control Defined by ADCT Total Score <7 Points
Up to 24 Months
Percentage of Participants with An ADCT Total Score Reduction >=5 from Baseline
Up to 24 Months
Percentage of Participants Achieving Disease Control as Defined by ADCT Item 4 (Sleep Problems) <1 Point and All Other Items <2 Points
Up to 24 Months
Percentage of Participants Achieving Disease Control as Defined by ADCT Total Score <7 Points at Month 3 and Maintaining Disease Control
Up to 21 Months (Excluding Month 3 - Primary Endpoint)
Absolute Score for ADCT Total Score
Up to 24 Months
- +82 more secondary outcomes
Study Arms (1)
Participants Receiving Upadacitinib
Participants receiving upadacitinib for moderate to severe atopic dermatitis.
Eligibility Criteria
Adolescent and adult participants with atopic dermatitis who have been prescribed upadacitinib in the course of routine practice according to relevant approved licenses.
You may qualify if:
- 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. The decision to prescribe upadacitinib must have been made prior to and independently of study participation.
- Medical and medication history available at least for the last 6 months.
You may not qualify if:
- \- Current participation in interventional research (note: this does not include non-interventional, post-marketing observational studies, or registry participation).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (125)
Private Practice - Dr. Sung-Hei Hong-Weldemann /ID# 248844
Freiburg im Breisgau, Baden-Wurttemberg, 79098, Germany
Durani & Durani, Heidelberg,DE /ID# 249172
Heidelberg, Baden-Wurttemberg, 69115, Germany
Universitaetsklinik Heidelberg /ID# 245834
Heidelberg, Baden-Wurttemberg, 69120, Germany
Hautarztpraxis Langenau /ID# 242279
Langenau, Baden-Wurttemberg, 89129, Germany
Flegl MD Stuttgart Germany /ID# 250302
Stuttgart, Baden-Wurttemberg, 70567, Germany
Kurzen, Freising, DE /ID# 241845
Freising, Bavaria, 85354, Germany
Beldio Research GmbH /ID# 245830
Memmingen, Bavaria, 87700, Germany
Dermazent /Id# 268146
Munich, Bavaria, 80331, Germany
Voelkel, Nuremberg, DE /ID# 252445
Nuremberg, Bavaria, 90419, Germany
Hautarzte im Novum Medicum Dr. Kreienkamp & Sautter /ID# 276060
Würzburg, Bavaria, 97080, Germany
Praxis Dres. Freitag/Knoell /ID# 242278
Falkensee, Brandenburg, 14612, Germany
Dermatologie Kleinmachnow /ID# 268383
Kleinmachnow, Brandenburg, 14532, Germany
Praxis Dr. Behnke /ID# 248870
Panketal, Brandenburg, 16341, Germany
Praxis Dr. Asadullah /ID# 243944
Potsdam, Brandenburg, 14467, Germany
Hautärzte am Nauener Tor /ID# 261533
Potsdam, Brandenburg, 14469, Germany
Hautarztpraxis Dr. Alexander Magerl /ID# 270749
Bensheim, Hesse, 64625, Germany
Universitaetsklinikum Frankfurt /ID# 241766
Frankfurt am Main, Hesse, 60590, Germany
MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 243328
Oberursel, Hesse, 61440, Germany
MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 249180
Oberursel, Hesse, 61440, Germany
Hautcentrum Wiesbaden /ID# 274848
Wiesbaden, Hesse, 65183, Germany
Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 241658
Bramsche, Lower Saxony, 49565, Germany
Praxis Dres. Kaspari /Schenck /ID# 241688
Hanover, Lower Saxony, 30159, Germany
Herrmann, Greifswald, DE /ID# 241889
Greifswald, Mecklenburg-Vorpommern, 17489, Germany
Hoeller-Obrigkeit, Aachen, DE /ID# 245430
Aachen, North Rhine-Westphalia, 52064, Germany
Klinikum Rosenhoehe /ID# 241601
Bielefeld, North Rhine-Westphalia, 33647, Germany
Katholisches Klinikum Bochum gGmbH /ID# 270537
Bochum, North Rhine-Westphalia, 44791, Germany
Kramer/Mortazawi, Remscheid /ID# 241824
Remscheid, North Rhine-Westphalia, 42897, Germany
Karl, Soest, DE /ID# 241909
Soest, North Rhine-Westphalia, 59494, Germany
Bell, Andernach, DE /ID# 249154
Andernach, Rhineland-Palatinate, 56626, Germany
Grossmann, Koblenz, DE /ID# 242992
Koblenz, Rhineland-Palatinate, 56068, Germany
Hautarztpraxis Dr. Kirschner /ID# 266738
Mainz, Rhineland-Palatinate, 55116, Germany
CMS3 Company for Medical Study /ID# 241659
Selters, Rhineland-Palatinate, 56242, Germany
Dermatologisches Studienzentrum am Haut- und Laserzentrum /ID# 243882
Simmern, Rhineland-Palatinate, 55469, Germany
HMS GmbH Zimmer /ID# 241657
Merzig, Saarland, 66663, Germany
Praxis P. Hausler-Mehlhorn /ID# 241527
Chemnitz, Saxony, 09130, Germany
Neubauer, Leipzig, DE /ID# 241823
Leipzig, Saxony, 04209, Germany
Praxis Dr. Raschke /ID# 251398
Magdeburg, Saxony-Anhalt, 39104, Germany
Praxis Dr. Mempel /ID# 241827
Elmshorn, Schleswig-Holstein, 25335, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 240096
Kiel, Schleswig-Holstein, 24105, Germany
Dermatologie Moelln Praxis Dr. Bodo Segert /ID# 242280
Mölln, Schleswig-Holstein, 23879, Germany
Praxis Liebetrau /ID# 271896
Friedrichroda, Thuringia, 99894, Germany
Petri, Ahaus, DE /ID# 243452
Ahaus, 48683, Germany
Dr. Stoeber /ID# 251066
Ahlen, 59227, Germany
Praxis Dr. Mihaescu /ID# 241825
Augsburg, 86150, Germany
MVZ medicum.mittelhessen /ID# 266126
Bad Camberg, 65520, Germany
Mauer, Bad Kreuznach, DE /ID# 241990
Bad Kreuznach, 55543, Germany
Timmel/Timm/Vorwerk, Bergen /ID# 241661
Bergen, 18528, Germany
Hautarztpraxis Dr. med. Christiane Handrick /ID# 262667
Berlin, 10117, Germany
Praxis Dermatologie am Savigny /ID# 248846
Berlin, 10623, Germany
Private Practice - Dr. Gellrich, Dr. Klein & Dr. Soost /ID# 250301
Berlin, 12247, Germany
Schirmer, Berlin, DE /ID# 241684
Berlin, 12489, Germany
Kors, Berlin, DE /ID# 241847
Berlin, 13086, Germany
Dues/Manasterski, Berlin, DE /ID# 243885
Berlin, 13507, Germany
Hautarztzentrum Tegel /ID# 241826
Berlin, 13507, Germany
Haut Pur - Dermatologische Gemeinschaftspraxis /ID# 243943
Berlin, 13597, Germany
Hautarztpraxis Dr. Weid /ID# 265213
Bingen am Rhein, 55411, Germany
Praxis fuer Innere Medizin/Rheumatologie /ID# 241846
Blaubeuren Abbey, 89143, Germany
Praxis T. Schadeck /ID# 241768
Bogen, 94327, Germany
Barth, Borna, DE /ID# 248871
Borna, 04552, Germany
Schwichtenberg, Bremen, DE /ID# 241683
Bremen, 28779, Germany
Dr. Hoffmann /ID# 245423
Cologne, 50674, Germany
Derma Köln /ID# 241856
Cologne, 50737, Germany
Praxis Dr. Sbornik /ID# 241818
Deggendorf, 94469, Germany
Hautmedizin Delitzsch /ID# 251394
Delitzsch, 04509, Germany
Richter-Huhn, Dresden, DE /ID# 241822
Dresden, 01219, Germany
Praxis Dr. Korge /ID# 241531
Düren, 52349, Germany
Hautarztpraxis Friedberg Dr. med. Wilfried Jungkunz /ID# 248851
Friedberg (Hessen), 61169, Germany
Rotterdam, Gelsenkirchen, DE /ID# 241819
Gelsenkirchen, 45897, Germany
Gemeinschaftspraxis Rietkoetter und Jablonka /ID# 241821
Gelsenkirchen, 45899, Germany
Praxis Dr. Lange /ID# 241829
Gera, 07548, Germany
Loth, Gernsbach, DE /ID# 241828
Gernsbach, 76593, Germany
Hautarztpraxis Dr. Budihardja /ID# 241851
Giessen, 35392, Germany
Brinkmann & Partner, Gladbeck, /ID# 241850
Gladbeck, 45964, Germany
Dr. Krueger /ID# 265150
Goslar, 38640, Germany
Grossmann, Grossenhain, DE /ID# 250303
Großenhain, 01558, Germany
Praxis Dr. Wegener /ID# 263731
Hamburg, 20095, Germany
Cutaneum /ID# 249104
Hamburg, 20249, Germany
Dermatologikum Hamburg /ID# 245431
Hamburg, 20354, Germany
Duplicate_Hautarztpraxis Luetten/Sack /ID# 241534
Hamburg, 21109, Germany
Dr. Wrage-Brors /ID# 262705
Hamburg, 22179, Germany
Mensing Derma MVZ GmbH /ID# 272383
Hamburg, 22391, Germany
Private Practice - Dr. Daniela Kasche - Langelohstrasse /ID# 249102
Hamburg, 22549, Germany
MVZ Prof. Dr. Ockenfels Haut- und Allergie-Praxisklinik GmbH /ID# 245395
Hanau, 63450, Germany
Dr. Buerkle /ID# 250299
Haslach im Kinzigtal, 77716, Germany
Hautarztpraxis Haßberge /ID# 257648
Haßfurt, 97437, Germany
Gemeinschaftspraxis Dres. Anika Hünermund/Mario Pawlak /ID# 241908
Heilbad Heiligenstadt, 37308, Germany
Haut- u. Laserzentrum Heilbronn /ID# 250305
Heilbronn, 74072, Germany
Hausarztpraxis & Laserzentrum Dr. Zimmermann & Kollegen /ID# 251051
Heusenstamm, 63150, Germany
Praxis Dres. Bischoff/Danz /ID# 241852
Ilmenau, 98693, Germany
Stockmeier, Ingoldstadt, DE /ID# 248877
Ingolstadt, 85049, Germany
Hautarztpraxis Weidgang /ID# 248850
Jülich, 52428, Germany
Derma Sana /ID# 241854
Karlsruhe, 76133, Germany
Dermatologische Praxis Kempen /ID# 248852
Kempen, 47906, Germany
Praxis Dres. Bornemann/Reinerth /ID# 257649
Krefeld, 47798, Germany
Dres. Jacobs & Kollegen /ID# 241989
Kulmbach, 95326, Germany
Praxis Dres. Wiemers/Wiemers /ID# 241602
Leipzig, 04317, Germany
Haut- und Allergie-Zentrum Lippstadt /ID# 241929
Lippstadt, 59557, Germany
Hagemeier, Loehne, DE /ID# 241886
Löhne, 32584, Germany
Magdeburger Company for Medical Studies & Services GmbH /ID# 248849
Magdeburg, 39104, Germany
MVZ "Im Altstadtquartier" Magdeburg /ID# 261366
Magdeburg, 39104, Germany
Universitaetsklinikum Magdeburg /ID# 249174
Magdeburg, 39120, Germany
Hausärzte am Fastnachtsbrunnen /ID# 250304
Mainz, 55116, Germany
Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 243325
Mainz, 55128, Germany
Praxis A. Viculova /ID# 266133
Miltenberg, 63897, Germany
ZENTderma /ID# 241539
Mönchengladbach, 41061, Germany
Dermatologie im Tal Praxis Dr.med. Maria Leibl /ID# 266128
Munich, 80331, Germany
Hautzentrum am Marienplatz /ID# 248847
Munich, 80331, Germany
Quack, Munich, DE /ID# 241536
Munich, 81539, Germany
Dr. Gißler-Walter /ID# 248876
Mutterstadt, 67112, Germany
Dr. Rezai /ID# 250298
Münster, 48143, Germany
Dermatologie im Apfelgarten /ID# 263704
Neu Wulmstorf, 21629, Germany
Praxis Dr. Konstantin Ertner /ID# 249153
Nuremberg, 90402, Germany
Hockmann, Oelde, DE /ID# 241906
Oelde, 59302, Germany
Harzklinikum Dorothea Christiane Erxleben /ID# 251067
Quedlinburg, 06484, Germany
Dr. Schaefers /ID# 255492
Reutlingen, 72764, Germany
Praxis Dr. Fränken /ID# 241853
Schwelm, 58332, Germany
Gemeinschaftspraxis fur Dermatologie /ID# 245831
Stadtroda, 07646, Germany
Praxis Dr. Termeer /ID# 241662
Stuttgart, 70499, Germany
Jasnoch/Kock/Borrosch, Vechta, /ID# 252081
Vechta, 49377, Germany
Barnikol, Waltershausen, DE /ID# 241844
Waltershausen, 99880, Germany
Praxis Dehmel / Brand-Opitzer /ID# 243884
Wasserburg A. Inn, 83512, Germany
Dr. Barbara Kempkes, Werne /ID# 241910
Werne, 59368, Germany
Dr. med. Nicola Möller & Thomas Kurtenbach GbR Dermatologie im Zentrum /ID# 266130
Wiesbaden, 65185, Germany
Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 241907
Witten, 58453, Germany
Albrecht, Wurzen, DE /ID# 241988
Wurzen, 04808, Germany
Related Publications (1)
Weidinger S, Schadeck T, Jacobs F, Weyergraf A, Mortazawi D, Hagemann T, Abousamra F, Mosch T, Fritz B, Lauffer F. Early Achievement of High Treatment Targets in Moderate-to-Severe Atopic Dermatitis with Upadacitinib: Real-World Evidence from the Observational UP-TAINED Study. Dermatol Ther (Heidelb). 2025 Apr;15(4):919-931. doi: 10.1007/s13555-025-01373-7. Epub 2025 Mar 15.
PMID: 40087231DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2021
First Posted
December 1, 2021
Study Start
December 13, 2021
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
January 26, 2026
Record last verified: 2026-01