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

Last updated: March 28, 2024
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atopic Dermatitis

Allergies & Asthma

Skin Infections/disorders

Treatment

N/A

Clinical Study ID

NCT05139836
P21-705
  • Ages > 12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofenrollment.
  • Upadacitinib initiated as per the local label. The decision to prescribe upadacitinibmust have been made prior to and independently of study participation.
  • Medical and medication history available at least for the last 6 months.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 772
Study Start date:
December 13, 2021
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Universitaetsklinik Heidelberg /ID# 245834

    Heidelberg, Baden-Wuerttemberg 69120
    Germany

    Active - Recruiting

  • Praxis Dr. Behnke /ID# 248870

    Panketal, Brandenburg 16341
    Germany

    Active - Recruiting

  • Hautärzte am Nauener Tor /ID# 261533

    Potsdam, Brandenburg 14469
    Germany

    Active - Recruiting

  • Praxis Dr. Asadullah /ID# 243944

    Potsdam, Brandenburg 14467
    Germany

    Active - Recruiting

  • Universitaetsklinikum Frankfurt /ID# 241766

    Frankfurt am Main, Hessen 60590
    Germany

    Active - Recruiting

  • CMS3 Company for Medical Study /ID# 241659

    Selters, Rheinland-Pfalz 56242
    Germany

    Active - Recruiting

  • HMS GmbH Zimmer /ID# 241657

    Merzig, Saarland 66663
    Germany

    Active - Recruiting

  • Praxis Dr. Mempel /ID# 241827

    Elmshorn, Schleswig-Holstein 25335
    Germany

    Active - Recruiting

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 240096

    Kiel, Schleswig-Holstein 24105
    Germany

    Active - Recruiting

  • Dermatologie Moelln Praxis Dr. Bodo Segert /ID# 242280

    Mölln, Schleswig-Holstein 23879
    Germany

    Active - Recruiting

  • Hoeller-Obrigkeit, Aachen, DE /ID# 245430

    Aachen, 52064
    Germany

    Active - Recruiting

  • Petri, Ahaus, DE /ID# 243452

    Ahaus, 48683
    Germany

    Active - Recruiting

  • Dr. Stoeber /ID# 251066

    Ahlen, 59227
    Germany

    Active - Recruiting

  • Bell, Andernach, DE /ID# 249154

    Andernach, 56626
    Germany

    Active - Recruiting

  • Praxis Dr. Mihaescu /ID# 241825

    Augsburg, 86150
    Germany

    Active - Recruiting

  • Praxis S. Bresgulewski /ID# 244331

    Bad Bertrich, 56864
    Germany

    Site Not Available

  • Mauer, Bad Kreuznach, DE /ID# 241990

    Bad Kreuznach, 55543
    Germany

    Active - Recruiting

  • Timmel/Timm/Vorwerk, Bergen /ID# 241661

    Bergen, 18528
    Germany

    Active - Recruiting

  • Dre. Gellrich/Klein/Soost /ID# 250301

    Berlin, 12247
    Germany

    Active - Recruiting

  • Dues/Manasterski, Berlin, DE /ID# 243885

    Berlin, 13507
    Germany

    Active - Recruiting

  • Haut Pur - Dermatologische Gemeinschaftspraxis /ID# 243943

    Berlin, 13597
    Germany

    Active - Recruiting

  • Hautarztpraxis Dr. med. Christiane Handrick /ID# 262667

    Berlin, 10117
    Germany

    Active - Recruiting

  • Hautarztzentrum Tegel /ID# 241826

    Berlin, 13507
    Germany

    Active - Recruiting

  • Kors, Berlin, DE /ID# 241847

    Berlin, 13086
    Germany

    Active - Recruiting

  • Praxis Dermatologie am Savigny /ID# 248846

    Berlin, 10623
    Germany

    Active - Recruiting

  • Schirmer, Berlin, DE /ID# 241684

    Berlin, 12489
    Germany

    Active - Recruiting

  • Klinikum Rosenhoehe /ID# 241601

    Bielefeld, 33647
    Germany

    Active - Recruiting

  • Praxis fuer Innere Medizin/Rheumatologie /ID# 241846

    Blaubeuren, 89143
    Germany

    Active - Recruiting

  • Praxis T. Schadeck /ID# 241768

    Bogen, 94327
    Germany

    Active - Recruiting

  • Barth, Borna, DE /ID# 248871

    Borna, 04552
    Germany

    Active - Recruiting

  • Studiengesellschaft an der Hase GbR Praxis Weyergraf/Frick/Heiber /ID# 241658

    Bramsche, 49565
    Germany

    Active - Recruiting

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

    Bramsche, 49565
    Germany

    Active - Recruiting

  • Schwichtenberg, Bremen, DE /ID# 241683

    Bremen, 28779
    Germany

    Active - Recruiting

  • Praxis P. Hausler-Mehlhorn /ID# 241527

    Chemnitz, 09130
    Germany

    Active - Recruiting

  • Derma Köln /ID# 241856

    Cologne, 50737
    Germany

    Active - Recruiting

  • Dr. Hoffmann /ID# 245423

    Cologne, 50674
    Germany

    Active - Recruiting

  • Praxis Dr. Sbornik /ID# 241818

    Deggendorf, 94469
    Germany

    Active - Recruiting

  • Hautmedizin Delitzsch /ID# 251394

    Delitzsch, 04509
    Germany

    Active - Recruiting

  • Richter-Huhn, Dresden, DE /ID# 241822

    Dresden, 01219
    Germany

    Active - Recruiting

  • Praxis Dr. Korge /ID# 241531

    Dueren, 52349
    Germany

    Active - Recruiting

  • Praxis Dres. Freitag/Knoell /ID# 242278

    Falkensee, 14612
    Germany

    Active - Recruiting

  • Praxis Dr. Hong-Weldemann /ID# 248844

    Freiburg im Breisgau, 79098
    Germany

    Active - Recruiting

  • Kurzen, Freising, DE /ID# 241845

    Freising, 85354
    Germany

    Active - Recruiting

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

    Friedberg (Hessen), 61169
    Germany

    Active - Recruiting

  • Gemeinschaftspraxis Rietkoetter und Jablonka /ID# 241821

    Gelsenkirchen, 45899
    Germany

    Active - Recruiting

  • Rotterdam, Gelsenkirchen, DE /ID# 241819

    Gelsenkirchen, 45897
    Germany

    Active - Recruiting

  • Praxis Dr. Lange /ID# 241829

    Gera, 07548
    Germany

    Active - Recruiting

  • Loth, Gernsbach, DE /ID# 241828

    Gernsbach, 76593
    Germany

    Active - Recruiting

  • Hautarztpraxis Dr. Budihardja /ID# 241851

    Gießen, 35392
    Germany

    Active - Recruiting

  • Brinkmann & Partner, Gladbeck, /ID# 241850

    Gladbeck, 45964
    Germany

    Active - Recruiting

  • Dr. Krueger /ID# 265150

    Goslar, 38640
    Germany

    Active - Recruiting

  • Herrmann, Greifswald, DE /ID# 241889

    Greifswald, 17489
    Germany

    Active - Recruiting

  • Grossmann, Grossenhain, DE /ID# 250303

    Grossenhain, 01558
    Germany

    Active - Recruiting

  • Cutaneum /ID# 249104

    Hamburg, 20249
    Germany

    Active - Recruiting

  • Dermatologikum Hamburg GmbH /ID# 245431

    Hamburg, 20354
    Germany

    Active - Recruiting

  • Hautarztpraxis Luetten/Sack /ID# 241534

    Hamburg, 21109
    Germany

    Active - Recruiting

  • Praxis Dr. Kasche /ID# 249102

    Hamburg, 22549
    Germany

    Active - Recruiting

  • Praxis Dr. Wegener /ID# 263731

    Hamburg, 20095
    Germany

    Active - Recruiting

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

    Hanau, 63450
    Germany

    Active - Recruiting

  • Praxis Dres. Kaspari /Schenck /ID# 241688

    Hannover, 30159
    Germany

    Active - Recruiting

  • Zentrum fuer Rheumatologie und Schmerzmedizin /ID# 244326

    Hanover, 30159
    Germany

    Site Not Available

  • Dr. Buerkle /ID# 250299

    Haslach im Kinzigtal, 77716
    Germany

    Active - Recruiting

  • Hautarztpraxis Haßberge /ID# 257648

    Haßfurt, 97437
    Germany

    Active - Recruiting

  • Durani & Durani, Heidelberg,DE /ID# 249172

    Heidelberg, 69115
    Germany

    Active - Recruiting

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

    Heilbad Heiligenstadt, 37308
    Germany

    Active - Recruiting

  • Haut- u. Laserzentrum Heilbronn /ID# 250305

    Heilbronn, 74072
    Germany

    Active - Recruiting

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

    Heusenstamm, 63150
    Germany

    Active - Recruiting

  • Praxis Dres. Bischoff/Danz /ID# 241852

    Ilmenau, 98693
    Germany

    Active - Recruiting

  • Stockmeier, Ingoldstadt, DE /ID# 248877

    Ingolstadt, 85049
    Germany

    Active - Recruiting

  • Hautarztpraxis Weidgang /ID# 248850

    Juelich, 52428
    Germany

    Active - Recruiting

  • Derma Sana /ID# 241854

    Karlsruhe, 76133
    Germany

    Active - Recruiting

  • Dermatologische Praxis Kempen /ID# 248852

    Kempen, 47906
    Germany

    Active - Recruiting

  • Grossmann, Koblenz, DE /ID# 242992

    Koblenz, 56068
    Germany

    Active - Recruiting

  • Praxis Dres. Bornemann/Reinerth /ID# 257649

    Krefeld, 47798
    Germany

    Active - Recruiting

  • Dres. Jacobs & Kollegen /ID# 241989

    Kulmbach, 95326
    Germany

    Active - Recruiting

  • Hautarztpraxis Langenau /ID# 242279

    Langenau, 89129
    Germany

    Active - Recruiting

  • Neubauer, Leipzig, DE /ID# 241823

    Leipzig, 04209
    Germany

    Active - Recruiting

  • Praxis Dres. Wiemers/Wiemers /ID# 241602

    Leipzig, 04317
    Germany

    Active - Recruiting

  • Haut- und Allergie-Zentrum Lippstadt /ID# 241929

    Lippstadt, 59557
    Germany

    Active - Recruiting

  • Hagemeier, Loehne, DE /ID# 241886

    Loehne, 32584
    Germany

    Completed

  • Dres. Reimers/Schulz-Kiesow /ID# 251069

    Lübeck, 23568
    Germany

    Site Not Available

  • MVZ "Im Altstadtquartier" Magdeburg /ID# 261366

    Magdeburg, 39104
    Germany

    Active - Recruiting

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

    Magdeburg, 39104
    Germany

    Active - Recruiting

  • Praxis Dr. Raschke /ID# 251398

    Magdeburg, 39104
    Germany

    Active - Recruiting

  • Universitaetsklinikum Magdeburg /ID# 249174

    Magdeburg, 39120
    Germany

    Active - Recruiting

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

    Mainz, 55128
    Germany

    Active - Recruiting

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

    Mainz, 55128
    Germany

    Active - Recruiting

  • Hausärzte am Fastnachtsbrunnen /ID# 250304

    Mainz, 55116
    Germany

    Active - Recruiting

  • Beldio Research GmbH /ID# 245830

    Memmingen, 87700
    Germany

    Active - Recruiting

  • Praxis A. Viculova /ID# 266133

    Miltenberg, 63897
    Germany

    Active - Recruiting

  • Hautzentrum am Marienplatz /ID# 248847

    Munich, 80331
    Germany

    Active - Recruiting

  • Quack, Munich, DE /ID# 241536

    Munich, 81539
    Germany

    Active - Recruiting

  • Dr. Gißler-Walter /ID# 248876

    Mutterstadt, 67112
    Germany

    Active - Recruiting

  • ZENTderma /ID# 241539

    Mönchengladbach, 41061
    Germany

    Active - Recruiting

  • Dr. Rezai /ID# 250298

    Münster, 48143
    Germany

    Active - Recruiting

  • Dermatologie im Apfelgarten /ID# 263704

    Neu Wulmstorf, 21629
    Germany

    Active - Recruiting

  • Praxis Dr. Konstantin Ertner /ID# 249153

    Nuremberg, 90402
    Germany

    Active - Recruiting

  • Voelkel, Nuremberg, DE /ID# 252445

    Nuremberg, 90419
    Germany

    Active - Recruiting

  • MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 243328

    Oberursel, 61440
    Germany

    Active - Recruiting

  • Hockmann, Oelde, DE /ID# 241906

    Oelde, 59302
    Germany

    Active - Recruiting

  • Baumann & Lang, Plauen, DE /ID# 244325

    Plauen, 08523
    Germany

    Site Not Available

  • Harzklinikum Dorothea Christiane Erxleben /ID# 251067

    Quedlinburg, 06484
    Germany

    Active - Recruiting

  • Kramer/Mortazawi, Remscheid /ID# 241824

    Remscheid, 42897
    Germany

    Active - Recruiting

  • Dr. Schaefers /ID# 255492

    Reutlingen, 72764
    Germany

    Active - Recruiting

  • Praxis Dr. Fränken /ID# 241853

    Schwelm, 58332
    Germany

    Active - Recruiting

  • Haut- und Laserzentrum Hunsrück /ID# 243882

    Simmern, 55469
    Germany

    Active - Recruiting

  • Karl, Soest, DE /ID# 241909

    Soest, 59494
    Germany

    Active - Recruiting

  • Gemeinschaftspraxis fur Dermatologie /ID# 245831

    Stadtroda, 07646
    Germany

    Completed

  • Flegl MD Stuttgart Germany /ID# 250302

    Stuttgart, 70567
    Germany

    Active - Recruiting

  • Praxis Dr. Termeer /ID# 241662

    Stuttgart, 70499
    Germany

    Site Not Available

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

    Vechta, 49377
    Germany

    Active - Recruiting

  • Barnikol, Waltershausen, DE /ID# 241844

    Waltershausen, 99880
    Germany

    Active - Recruiting

  • Praxis Dehmel / Brand-Opitzer /ID# 243884

    Wasserburg A. Inn, 83512
    Germany

    Active - Recruiting

  • Dr. Barbara Kempkes, Werne /ID# 241910

    Werne, 59368
    Germany

    Active - Recruiting

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

    Wiesbaden, 65185
    Germany

    Active - Recruiting

  • Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 241907

    Witten, 58453
    Germany

    Active - Recruiting

  • Albrecht, Wurzen, DE /ID# 241988

    Wurzen, 04808
    Germany

    Active - Recruiting

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