A Study to Assess Disease Activity in Adolescent and Adult Participants With Atopic Dermatitis Who Receive Oral Upadacitinib Tablets in a Real-World Setting

NCT ID: NCT05139836

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 634 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-13
• Study Completion Date: 2027-09-30

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.

Conditions

Atopic Dermatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants Receiving Upadacitinib

Participants receiving upadacitinib for moderate to severe atopic dermatitis.

No interventions assigned to this group

Eligibility Criteria

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. 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.

Exclusion Criteria

• Current participation in interventional research (note: this does not include non-interventional, post-marketing observational studies, or registry participation).

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Private Practice - Dr. Sung-Hei Hong-Weldemann /ID# 248844

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Durani & Durani, Heidelberg,DE /ID# 249172

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinik Heidelberg /ID# 245834

Heidelberg, Baden-Wurttemberg, Germany

Hautarztpraxis Langenau /ID# 242279

Langenau, Baden-Wurttemberg, Germany

Flegl MD Stuttgart Germany /ID# 250302

Stuttgart, Baden-Wurttemberg, Germany

Kurzen, Freising, DE /ID# 241845

Freising, Bavaria, Germany

Beldio Research GmbH /ID# 245830

Memmingen, Bavaria, Germany

Dermazent /Id# 268146

Munich, Bavaria, Germany

Voelkel, Nuremberg, DE /ID# 252445

Nuremberg, Bavaria, Germany

Hautarzte im Novum Medicum Dr. Kreienkamp & Sautter /ID# 276060

Würzburg, Bavaria, Germany

Praxis Dres. Freitag/Knoell /ID# 242278

Falkensee, Brandenburg, Germany

Dermatologie Kleinmachnow /ID# 268383

Kleinmachnow, Brandenburg, Germany

Praxis Dr. Behnke /ID# 248870

Panketal, Brandenburg, Germany

Praxis Dr. Asadullah /ID# 243944

Potsdam, Brandenburg, Germany

Hautärzte am Nauener Tor /ID# 261533

Potsdam, Brandenburg, Germany

Hautarztpraxis Dr. Alexander Magerl /ID# 270749

Bensheim, Hesse, Germany

Universitaetsklinikum Frankfurt /ID# 241766

Frankfurt am Main, Hesse, Germany

MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 243328

Oberursel, Hesse, Germany

MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 249180

Oberursel, Hesse, Germany

Hautcentrum Wiesbaden /ID# 274848

Wiesbaden, Hesse, Germany

Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 241658

Bramsche, Lower Saxony, Germany

Praxis Dres. Kaspari /Schenck /ID# 241688

Hanover, Lower Saxony, Germany

Herrmann, Greifswald, DE /ID# 241889

Greifswald, Mecklenburg-Vorpommern, Germany

Hoeller-Obrigkeit, Aachen, DE /ID# 245430

Aachen, North Rhine-Westphalia, Germany

Klinikum Rosenhoehe /ID# 241601

Bielefeld, North Rhine-Westphalia, Germany

Katholisches Klinikum Bochum gGmbH /ID# 270537

Bochum, North Rhine-Westphalia, Germany

Kramer/Mortazawi, Remscheid /ID# 241824

Remscheid, North Rhine-Westphalia, Germany

Karl, Soest, DE /ID# 241909

Soest, North Rhine-Westphalia, Germany

Bell, Andernach, DE /ID# 249154

Andernach, Rhineland-Palatinate, Germany

Grossmann, Koblenz, DE /ID# 242992

Koblenz, Rhineland-Palatinate, Germany

Hautarztpraxis Dr. Kirschner /ID# 266738

Mainz, Rhineland-Palatinate, Germany

CMS3 Company for Medical Study /ID# 241659

Selters, Rhineland-Palatinate, Germany

Dermatologisches Studienzentrum am Haut- und Laserzentrum /ID# 243882

Simmern, Rhineland-Palatinate, Germany

HMS GmbH Zimmer /ID# 241657

Merzig, Saarland, Germany

Praxis P. Hausler-Mehlhorn /ID# 241527

Chemnitz, Saxony, Germany

Neubauer, Leipzig, DE /ID# 241823

Leipzig, Saxony, Germany

Praxis Dr. Raschke /ID# 251398

Magdeburg, Saxony-Anhalt, Germany

Praxis Dr. Mempel /ID# 241827

Elmshorn, Schleswig-Holstein, Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 240096

Kiel, Schleswig-Holstein, Germany

Dermatologie Moelln Praxis Dr. Bodo Segert /ID# 242280

Mölln, Schleswig-Holstein, Germany

Praxis Liebetrau /ID# 271896

Friedrichroda, Thuringia, Germany

Petri, Ahaus, DE /ID# 243452

Ahaus, , Germany

Dr. Stoeber /ID# 251066

Ahlen, , Germany

Praxis Dr. Mihaescu /ID# 241825

Augsburg, , Germany

MVZ medicum.mittelhessen /ID# 266126

Bad Camberg, , Germany

Mauer, Bad Kreuznach, DE /ID# 241990

Bad Kreuznach, , Germany

Timmel/Timm/Vorwerk, Bergen /ID# 241661

Bergen, , Germany

Hautarztpraxis Dr. med. Christiane Handrick /ID# 262667

Berlin, , Germany

Praxis Dermatologie am Savigny /ID# 248846

Berlin, , Germany

Private Practice - Dr. Gellrich, Dr. Klein & Dr. Soost /ID# 250301

Berlin, , Germany

Schirmer, Berlin, DE /ID# 241684

Berlin, , Germany

Kors, Berlin, DE /ID# 241847

Berlin, , Germany

Dues/Manasterski, Berlin, DE /ID# 243885

Berlin, , Germany

Hautarztzentrum Tegel /ID# 241826

Berlin, , Germany

Haut Pur - Dermatologische Gemeinschaftspraxis /ID# 243943

Berlin, , Germany

Hautarztpraxis Dr. Weid /ID# 265213

Bingen am Rhein, , Germany

Praxis fuer Innere Medizin/Rheumatologie /ID# 241846

Blaubeuren Abbey, , Germany

Praxis T. Schadeck /ID# 241768

Bogen, , Germany

Barth, Borna, DE /ID# 248871

Borna, , Germany

Schwichtenberg, Bremen, DE /ID# 241683

Bremen, , Germany

Dr. Hoffmann /ID# 245423

Cologne, , Germany

Derma Köln /ID# 241856

Cologne, , Germany

Praxis Dr. Sbornik /ID# 241818

Deggendorf, , Germany

Hautmedizin Delitzsch /ID# 251394

Delitzsch, , Germany

Richter-Huhn, Dresden, DE /ID# 241822

Dresden, , Germany

Praxis Dr. Korge /ID# 241531

Düren, , Germany

Hautarztpraxis Friedberg Dr. med. Wilfried Jungkunz /ID# 248851

Friedberg (Hessen), , Germany

Rotterdam, Gelsenkirchen, DE /ID# 241819

Gelsenkirchen, , Germany

Gemeinschaftspraxis Rietkoetter und Jablonka /ID# 241821

Gelsenkirchen, , Germany

Praxis Dr. Lange /ID# 241829

Gera, , Germany

Loth, Gernsbach, DE /ID# 241828

Gernsbach, , Germany

Hautarztpraxis Dr. Budihardja /ID# 241851

Giessen, , Germany

Brinkmann & Partner, Gladbeck, /ID# 241850

Gladbeck, , Germany

Dr. Krueger /ID# 265150

Goslar, , Germany

Grossmann, Grossenhain, DE /ID# 250303

Großenhain, , Germany

Praxis Dr. Wegener /ID# 263731

Hamburg, , Germany

Cutaneum /ID# 249104

Hamburg, , Germany

Dermatologikum Hamburg /ID# 245431

Hamburg, , Germany

Duplicate_Hautarztpraxis Luetten/Sack /ID# 241534

Hamburg, , Germany

Dr. Wrage-Brors /ID# 262705

Hamburg, , Germany

Mensing Derma MVZ GmbH /ID# 272383

Hamburg, , Germany

Private Practice - Dr. Daniela Kasche - Langelohstrasse /ID# 249102

Hamburg, , Germany

MVZ Prof. Dr. Ockenfels Haut- und Allergie-Praxisklinik GmbH /ID# 245395

Hanau, , Germany

Dr. Buerkle /ID# 250299

Haslach im Kinzigtal, , Germany

Hautarztpraxis Haßberge /ID# 257648

Haßfurt, , Germany

Gemeinschaftspraxis Dres. Anika Hünermund/Mario Pawlak /ID# 241908

Heilbad Heiligenstadt, , Germany

Haut- u. Laserzentrum Heilbronn /ID# 250305

Heilbronn, , Germany

Hausarztpraxis & Laserzentrum Dr. Zimmermann & Kollegen /ID# 251051

Heusenstamm, , Germany

Praxis Dres. Bischoff/Danz /ID# 241852

Ilmenau, , Germany

Stockmeier, Ingoldstadt, DE /ID# 248877

Ingolstadt, , Germany

Hautarztpraxis Weidgang /ID# 248850

Jülich, , Germany

Derma Sana /ID# 241854

Karlsruhe, , Germany

Dermatologische Praxis Kempen /ID# 248852

Kempen, , Germany

Praxis Dres. Bornemann/Reinerth /ID# 257649

Krefeld, , Germany

Dres. Jacobs & Kollegen /ID# 241989

Kulmbach, , Germany

Praxis Dres. Wiemers/Wiemers /ID# 241602

Leipzig, , Germany

Haut- und Allergie-Zentrum Lippstadt /ID# 241929

Lippstadt, , Germany

Hagemeier, Loehne, DE /ID# 241886

Löhne, , Germany

Magdeburger Company for Medical Studies & Services GmbH /ID# 248849

Magdeburg, , Germany

MVZ "Im Altstadtquartier" Magdeburg /ID# 261366

Magdeburg, , Germany

Universitaetsklinikum Magdeburg /ID# 249174

Magdeburg, , Germany

Hausärzte am Fastnachtsbrunnen /ID# 250304

Mainz, , Germany

Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 243325

Mainz, , Germany

Praxis A. Viculova /ID# 266133

Miltenberg, , Germany

ZENTderma /ID# 241539

Mönchengladbach, , Germany

Dermatologie im Tal Praxis Dr.med. Maria Leibl /ID# 266128

Munich, , Germany

Hautzentrum am Marienplatz /ID# 248847

Munich, , Germany

Quack, Munich, DE /ID# 241536

Munich, , Germany

Dr. Gißler-Walter /ID# 248876

Mutterstadt, , Germany

Dr. Rezai /ID# 250298

Münster, , Germany

Dermatologie im Apfelgarten /ID# 263704

Neu Wulmstorf, , Germany

Praxis Dr. Konstantin Ertner /ID# 249153

Nuremberg, , Germany

Hockmann, Oelde, DE /ID# 241906

Oelde, , Germany

Harzklinikum Dorothea Christiane Erxleben /ID# 251067

Quedlinburg, , Germany

Dr. Schaefers /ID# 255492

Reutlingen, , Germany

Praxis Dr. Fränken /ID# 241853

Schwelm, , Germany

Gemeinschaftspraxis fur Dermatologie /ID# 245831

Stadtroda, , Germany

Praxis Dr. Termeer /ID# 241662

Stuttgart, , Germany

Jasnoch/Kock/Borrosch, Vechta, /ID# 252081

Vechta, , Germany

Barnikol, Waltershausen, DE /ID# 241844

Waltershausen, , Germany

Praxis Dehmel / Brand-Opitzer /ID# 243884

Wasserburg A. Inn, , Germany

Dr. Barbara Kempkes, Werne /ID# 241910

Werne, , Germany

Dr. med. Nicola Möller & Thomas Kurtenbach GbR Dermatologie im Zentrum /ID# 266130

Wiesbaden, , Germany

Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 241907

Witten, , Germany

Albrecht, Wurzen, DE /ID# 241988

Wurzen, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 40087231 (View on PubMed)

Related Links

https://www.rxabbvie.com/

This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Other Identifiers

P21-705

Identifier Type: -

Identifier Source: org_study_id