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AzTrials

Atopic DermatitisUP-TAINEDNCT05139836

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

An observational study of Atopic Dermatitis, run by AbbVie at 125 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Atopic Dermatitis
How many people
634 participants
Where
125 sitesGermany
Study dates
13 Dec 2021to Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Adolescent and adult participants with atopic dermatitis who have been prescribed upadacitinib in the course of routine practice according to relevant approved licenses.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

125 sites in 1 country.

125 sites in 1 country

Germany125 sites
  • Hoeller-Obrigkeit, Aachen, DE /ID# 245430

    Aachen, North Rhine-Westphalia, 52064

  • Petri, Ahaus, DE /ID# 243452

    Ahaus, 48683

  • Dr. Stoeber /ID# 251066

    Ahlen, 59227

  • Bell, Andernach, DE /ID# 249154

    Andernach, Rhineland-Palatinate, 56626

  • Praxis Dr. Mihaescu /ID# 241825

    Augsburg, 86150

  • MVZ medicum.mittelhessen /ID# 266126

    Bad Camberg, 65520

  • Mauer, Bad Kreuznach, DE /ID# 241990

    Bad Kreuznach, 55543

  • Hautarztpraxis Dr. Alexander Magerl /ID# 270749

    Bensheim, Hesse, 64625

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

    Bergen, 18528

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

    Berlin, 10117

  • Praxis Dermatologie am Savigny /ID# 248846

    Berlin, 10623

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

    Berlin, 12247

  • Schirmer, Berlin, DE /ID# 241684

    Berlin, 12489

  • Kors, Berlin, DE /ID# 241847

    Berlin, 13086

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

    Berlin, 13507

  • Hautarztzentrum Tegel /ID# 241826

    Berlin, 13507

  • Haut Pur - Dermatologische Gemeinschaftspraxis /ID# 243943

    Berlin, 13597

  • Klinikum Rosenhoehe /ID# 241601

    Bielefeld, North Rhine-Westphalia, 33647

  • Hautarztpraxis Dr. Weid /ID# 265213

    Bingen am Rhein, 55411

  • Praxis fuer Innere Medizin/Rheumatologie /ID# 241846

    Blaubeuren Abbey, 89143

  • Katholisches Klinikum Bochum gGmbH /ID# 270537

    Bochum, North Rhine-Westphalia, 44791

  • Praxis T. Schadeck /ID# 241768

    Bogen, 94327

  • Barth, Borna, DE /ID# 248871

    Borna, 04552

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

    Bramsche, Lower Saxony, 49565

  • Schwichtenberg, Bremen, DE /ID# 241683

    Bremen, 28779

  • Praxis P. Hausler-Mehlhorn /ID# 241527

    Chemnitz, Saxony, 09130

  • Dr. Hoffmann /ID# 245423

    Cologne, 50674

  • Derma Köln /ID# 241856

    Cologne, 50737

  • Praxis Dr. Sbornik /ID# 241818

    Deggendorf, 94469

  • Hautmedizin Delitzsch /ID# 251394

    Delitzsch, 04509

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

    Dresden, 01219

  • Praxis Dr. Korge /ID# 241531

    Düren, 52349

  • Praxis Dr. Mempel /ID# 241827

    Elmshorn, Schleswig-Holstein, 25335

  • Praxis Dres. Freitag/Knoell /ID# 242278

    Falkensee, Brandenburg, 14612

  • Universitaetsklinikum Frankfurt /ID# 241766

    Frankfurt am Main, Hesse, 60590

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

    Freiburg im Breisgau, Baden-Wurttemberg, 79098

  • Kurzen, Freising, DE /ID# 241845

    Freising, Bavaria, 85354

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

    Friedberg (Hessen), 61169

  • Praxis Liebetrau /ID# 271896

    Friedrichroda, Thuringia, 99894

  • Rotterdam, Gelsenkirchen, DE /ID# 241819

    Gelsenkirchen, 45897

  • Gemeinschaftspraxis Rietkoetter und Jablonka /ID# 241821

    Gelsenkirchen, 45899

  • Praxis Dr. Lange /ID# 241829

    Gera, 07548

  • Loth, Gernsbach, DE /ID# 241828

    Gernsbach, 76593

  • Hautarztpraxis Dr. Budihardja /ID# 241851

    Giessen, 35392

  • Brinkmann & Partner, Gladbeck, /ID# 241850

    Gladbeck, 45964

  • Dr. Krueger /ID# 265150

    Goslar, 38640

  • Herrmann, Greifswald, DE /ID# 241889

    Greifswald, Mecklenburg-Vorpommern, 17489

  • Grossmann, Grossenhain, DE /ID# 250303

    Großenhain, 01558

  • Praxis Dr. Wegener /ID# 263731

    Hamburg, 20095

  • Cutaneum /ID# 249104

    Hamburg, 20249

  • Dermatologikum Hamburg /ID# 245431

    Hamburg, 20354

  • Duplicate_Hautarztpraxis Luetten/Sack /ID# 241534

    Hamburg, 21109

  • Dr. Wrage-Brors /ID# 262705

    Hamburg, 22179

  • Mensing Derma MVZ GmbH /ID# 272383

    Hamburg, 22391

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

    Hamburg, 22549

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

    Hanau, 63450

  • Praxis Dres. Kaspari /Schenck /ID# 241688

    Hanover, Lower Saxony, 30159

  • Dr. Buerkle /ID# 250299

    Haslach im Kinzigtal, 77716

  • Hautarztpraxis Haßberge /ID# 257648

    Haßfurt, 97437

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

    Heidelberg, Baden-Wurttemberg, 69115

  • Universitaetsklinik Heidelberg /ID# 245834

    Heidelberg, Baden-Wurttemberg, 69120

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

    Heilbad Heiligenstadt, 37308

  • Haut- u. Laserzentrum Heilbronn /ID# 250305

    Heilbronn, 74072

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

    Heusenstamm, 63150

  • Praxis Dres. Bischoff/Danz /ID# 241852

    Ilmenau, 98693

  • Stockmeier, Ingoldstadt, DE /ID# 248877

    Ingolstadt, 85049

  • Hautarztpraxis Weidgang /ID# 248850

    Jülich, 52428

  • Derma Sana /ID# 241854

    Karlsruhe, 76133

  • Dermatologische Praxis Kempen /ID# 248852

    Kempen, 47906

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 240096

    Kiel, Schleswig-Holstein, 24105

  • Dermatologie Kleinmachnow /ID# 268383

    Kleinmachnow, Brandenburg, 14532

  • Grossmann, Koblenz, DE /ID# 242992

    Koblenz, Rhineland-Palatinate, 56068

  • Praxis Dres. Bornemann/Reinerth /ID# 257649

    Krefeld, 47798

  • Dres. Jacobs & Kollegen /ID# 241989

    Kulmbach, 95326

  • Hautarztpraxis Langenau /ID# 242279

    Langenau, Baden-Wurttemberg, 89129

  • Neubauer, Leipzig, DE /ID# 241823

    Leipzig, Saxony, 04209

  • Praxis Dres. Wiemers/Wiemers /ID# 241602

    Leipzig, 04317

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

    Lippstadt, 59557

  • Hagemeier, Loehne, DE /ID# 241886

    Löhne, 32584

  • Praxis Dr. Raschke /ID# 251398

    Magdeburg, Saxony-Anhalt, 39104

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

    Magdeburg, 39104

  • MVZ "Im Altstadtquartier" Magdeburg /ID# 261366

    Magdeburg, 39104

  • Universitaetsklinikum Magdeburg /ID# 249174

    Magdeburg, 39120

  • Hautarztpraxis Dr. Kirschner /ID# 266738

    Mainz, Rhineland-Palatinate, 55116

  • Hausärzte am Fastnachtsbrunnen /ID# 250304

    Mainz, 55116

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

    Mainz, 55128

  • Beldio Research GmbH /ID# 245830

    Memmingen, Bavaria, 87700

  • HMS GmbH Zimmer /ID# 241657

    Merzig, Saarland, 66663

  • Praxis A. Viculova /ID# 266133

    Miltenberg, 63897

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

    Mölln, Schleswig-Holstein, 23879

  • ZENTderma /ID# 241539

    Mönchengladbach, 41061

  • Dermazent /Id# 268146

    Munich, Bavaria, 80331

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

    Munich, 80331

  • Hautzentrum am Marienplatz /ID# 248847

    Munich, 80331

  • Quack, Munich, DE /ID# 241536

    Munich, 81539

  • Dr. Rezai /ID# 250298

    Münster, 48143

  • Dr. Gißler-Walter /ID# 248876

    Mutterstadt, 67112

  • Dermatologie im Apfelgarten /ID# 263704

    Neu Wulmstorf, 21629

  • Voelkel, Nuremberg, DE /ID# 252445

    Nuremberg, Bavaria, 90419

  • Praxis Dr. Konstantin Ertner /ID# 249153

    Nuremberg, 90402

  • MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 243328

    Oberursel, Hesse, 61440

  • MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 249180

    Oberursel, Hesse, 61440

  • Hockmann, Oelde, DE /ID# 241906

    Oelde, 59302

  • Praxis Dr. Behnke /ID# 248870

    Panketal, Brandenburg, 16341

  • Praxis Dr. Asadullah /ID# 243944

    Potsdam, Brandenburg, 14467

  • Hautärzte am Nauener Tor /ID# 261533

    Potsdam, Brandenburg, 14469

  • Harzklinikum Dorothea Christiane Erxleben /ID# 251067

    Quedlinburg, 06484

  • Kramer/Mortazawi, Remscheid /ID# 241824

    Remscheid, North Rhine-Westphalia, 42897

  • Dr. Schaefers /ID# 255492

    Reutlingen, 72764

  • Praxis Dr. Fränken /ID# 241853

    Schwelm, 58332

  • CMS3 Company for Medical Study /ID# 241659

    Selters, Rhineland-Palatinate, 56242

  • Dermatologisches Studienzentrum am Haut- und Laserzentrum /ID# 243882

    Simmern, Rhineland-Palatinate, 55469

  • Karl, Soest, DE /ID# 241909

    Soest, North Rhine-Westphalia, 59494

  • Gemeinschaftspraxis fur Dermatologie /ID# 245831

    Stadtroda, 07646

  • Flegl MD Stuttgart Germany /ID# 250302

    Stuttgart, Baden-Wurttemberg, 70567

  • Praxis Dr. Termeer /ID# 241662

    Stuttgart, 70499

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

    Vechta, 49377

  • Barnikol, Waltershausen, DE /ID# 241844

    Waltershausen, 99880

  • Praxis Dehmel / Brand-Opitzer /ID# 243884

    Wasserburg A. Inn, 83512

  • Dr. Barbara Kempkes, Werne /ID# 241910

    Werne, 59368

  • Hautcentrum Wiesbaden /ID# 274848

    Wiesbaden, Hesse, 65183

  • Dr. med. Nicola Moller and Thomas Kurtenbach GbR Dermatologie im Zentrum /ID# 266130

    Wiesbaden, Hesse, 65185

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

    Witten, 58453

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

    Würzburg, Bavaria, 97080

  • Albrecht, Wurzen, DE /ID# 241988

    Wurzen, 04808

Other trials in Germany

About this study

Official title: 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

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.

Read more

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.

Keywords
Atopic Dermatitis (AD), Upadacitinib, RINVOQ
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05139836
Study groupRoleWhat they receive
Participants Receiving UpadacitinibParticipants receiving upadacitinib for moderate to severe atopic dermatitis.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Month 3

  2. 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.

    Measured: Month 24

Secondary outcomes (87)
  1. Percentage of Participants Achieving Disease Control Defined by 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.

    Measured: Up to 24 Months

  2. Percentage of Participants with An ADCT Total Score Reduction >=5 from Baseline

    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.

    Measured: Up to 24 Months

  3. Percentage of Participants Achieving Disease Control as Defined by ADCT Item 4 (Sleep Problems) <1 Point and All Other Items <2 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.

    Measured: Up to 24 Months

  4. Percentage of Participants Achieving Disease Control as Defined by ADCT Total Score <7 Points at Month 3 and Maintaining Disease Control

    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.

    Measured: Up to 21 Months (Excluding Month 3 - Primary Endpoint)

  5. Absolute Score for ADCT Total Score

    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.

    Measured: Up to 24 Months

  6. Absolute Change from Baseline for ADCT Total Score

    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.

    Measured: Up to 24 Months

  7. Time to Achieve ADCT Total Score Reduction >=5 Points from Baseline

    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.

    Measured: Up to 24 Months

  8. Time to Achieve Disease Control as Defined by 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.

    Measured: Up to 24 Months

  9. Percent Change from Baseline for ADCT Total Score

    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.

    Measured: Up to 24 Months

  10. Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 50

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to 24 Months

  11. Percentage of Participants Achieving EASI 75

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to 24 Months

  12. Percentage of Participants Achieving EASI 90

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to 24 Months

  13. Percentage of Participants Achieving EASI 100

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to 24 Months

  14. Percentage of Participants Achieving Absolute EASI <=7

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to 24 Months

  15. Absolute Score for EASI

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to 24 Months

  16. Absolute Change from Baseline for EASI

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to 24 Months

  17. Percent Change from Baseline for EASI

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to 24 Months

  18. Time to Achieve EASI 50

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to 24 Months

  19. Time to Achieve EASI 75

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to 24 Months

  20. Time to Achieve EASI 90

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to 24 Months

  21. Time to Achieve EASI 100

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to 24 Months

  22. Time to Achieve Absolute EASI <=7

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to 24 Months

  23. Percentage of Participants Achieving EASI 50 in the Head and/or Neck Body Region

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to 24 Months

  24. Percentage of Participants Achieving EASI 75 in the Head and/or Neck Body Region

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to 24 Months

  25. Percentage of Participants Achieving EASI 90 in the Head and/or Neck Body Region

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to 24 Months

  26. Percentage of Participants Achieving EASI 100 in the Head and/or Neck Body Region

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are each assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. The EASI score ranges from 0-72 points with an MCID of 6.6 points. Published score bands: clear (0), almost clear (0.1-1.0), mild AD (1.1-7.0), moderate AD (7.1-21.0), severe AD (21.1-50.0), very severe AD (50.1-72.0).

    Measured: Up to 24 Months

  27. Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) <=1

    WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: Up to 24 Months

  28. Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) <=1

    vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.

    Measured: Up to 24 Months

  29. Percentage of Participants Achieving WP-NRS <=3

    WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: Up to 24 Months

  30. Percentage of Participants Achieving a WP-NRS Reduction >=4 from Baseline

    WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: Up to 24 Months

  31. Absolute Score for WP-NRS

    WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: Up to 24 Months

  32. Absolute Change from Baseline for WP-NRS

    WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: Up to 24 Months

  33. Percent Change from Baseline for WP-NRS

    WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: Up to 24 Months

  34. Time to Achieve WP-NRS <=1

    WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours with a higher score denoting worse itch.

    Measured: Up to 24 Months

  35. Absolute Score for Score Atopic Dermatitis (SCORAD) Sleep Visual Analog Scale (VAS)

    The sleep VAS is one component from the SCORAD test that measures the intensity of sleeplessness during a three day or night recall period. The test uses a VAS scale of 0 to 10 with 0 being "no sleeplessness" and 10 being "worst imaginable sleeplessness".

    Measured: Up to 24 Months

  36. Absolute Change from Baseline for SCORAD Sleep VAS

    The sleep VAS is one component from the SCORAD test that measures the intensity of sleeplessness during a three day or night recall period. The test uses a VAS scale of 0 to 10 with 0 being "no sleeplessness" and 10 being "worst imaginable sleeplessness".

    Measured: Up to 24 Months

  37. Percent Change from Baseline for SCORAD Sleep VAS

    The sleep VAS is one component from the SCORAD test that measures the intensity of sleeplessness during a three day or night recall period. The test uses a VAS scale of 0 to 10 with 0 being "no sleeplessness" and 10 being "worst imaginable sleeplessness".

    Measured: Up to 24 Months

  38. Percentage of Participants Achieving Dermatology Life Quality Index (DLQI)/Children's Dermatology Life Quality Index (cDLQI) <=1

    DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used.

    Measured: Up to 24 Months

  39. Percentage of Participants Achieving DLQI/cDLQI <=5

    DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used.

    Measured: Up to 24 Months

  40. Percentage of Participants Achieving DLQI/cDLQI Reduction >=4 from Baseline

    DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used.

    Measured: Up to 24 Months

  41. Absolute Score for DLQI/cDLQI

    DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used.

    Measured: Up to 24 Months

  42. Absolute Change from Baseline for DLQI/cDLQI

    DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used.

    Measured: Up to 24 Months

  43. Percent Change from Baseline for DLQI/cDLQI

    DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used.

    Measured: Up to 24 Months

  44. Time to Achieve DLQI/cDLQI <=1

    DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of subject's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL. For patients from age 12-15 the cDLQI is used.

    Measured: Up to 24 Months

  45. Absolute Score for Hospital Anxiety and Depression Scale for Anxiety (HADS-A)

    The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity.

    Measured: Up to 24 Months

  46. Absolute Change from Baseline for HADS-A

    The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity.

    Measured: Up to 24 Months

  47. Percent Change from Baseline for HADS-A

    The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity.

    Measured: Up to 24 Months

  48. Absolute Score for Hospital Anxiety and Depression Scale for Depression (HADS-D)

    The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity.

    Measured: Up to 24 Months

  49. Absolute Change from Baseline for HADS-D

    The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity.

    Measured: Up to 24 Months

  50. Percent Change from Baseline for HADS-D

    The HADS is a 14-item self-report scale, It contains two 7-item scales: one for anxiety (HADS-A) and one for depression (HADS-D). Each HADS item is rated on a 4-point Likert-type scale with total scores on each subscale ranging from 0 to 21, and with higher scores corresponding to greater respective symptom severity.

    Measured: Up to 24 Months

  51. Absolute Score for Stigmatization (6-Item Stigmatization Scale)

    The scale consists of 6 items that address the feeling of stigmatization because of this condition. The participants respond to each item by 0 (not at all), 1 (sometimes), 2 (very often), or 3 (always). The sum of the responses to the 6 items generates a score ranging from 0 to 18 with higher scores corresponding to a higher feeling of stigmatization.

    Measured: Up to 24 Months

  52. Absolute Change from Baseline for Stigmatization (6-Item Stigmatization Scale)

    The scale consists of 6 items that address the feeling of stigmatization because of this condition. The participants respond to each item by 0 (not at all), 1 (sometimes), 2 (very often), or 3 (always). The sum of the responses to the 6 items generates a score ranging from 0 to 18 with higher scores corresponding to a higher feeling of stigmatization.

    Measured: Up to 24 Months

  53. Percent Change from Baseline for Stigmatization (6-Item Stigmatization Scale)

    The scale consists of 6 items that address the feeling of stigmatization because of this condition. The participants respond to each item by 0 (not at all), 1 (sometimes), 2 (very often), or 3 (always). The sum of the responses to the 6 items generates a score ranging from 0 to 18 with higher scores corresponding to a higher feeling of stigmatization.

    Measured: Up to 24 Months

  54. Absolute Score for Asthma Control Test (ACT) in Participants Having a Confirmed Diagnosis of Asthma at Baseline

    The ACT consists of 5 simple questions regarding the patients' asthma symptom burden. For each question there is a range from 1 to 5. A lower score indicates lower asthma control.

    Measured: Up to 24 Months

  55. Absolute Change from Baseline in ACT in Participants Having a Confirmed Diagnosis of Asthma at Baseline

    The ACT consists of 5 simple questions regarding the patients' asthma symptom burden. For each question there is a range from 1 to 5. A lower score indicates lower asthma control.

    Measured: Up to 24 Months

  56. Percent Change from Baseline in ACT in Participants Having a Confirmed Diagnosis of Asthma at Baseline

    The ACT consists of 5 simple questions regarding the patients' asthma symptom burden. For each question there is a range from 1 to 5. A lower score indicates lower asthma control.

    Measured: Up to 24 Months

  57. Percentage of Participants Achieving Absolute Score >=20 for ACT in Participants Having a Confirmed Diagnosis of Asthma at Baseline

    The ACT consists of 5 simple questions regarding the patients' asthma symptom burden. For each question there is a range from 1 to 5. A lower score indicates lower asthma control.

    Measured: Up to 24 Months

  58. Percentage of Participants Starting on Upadacitinib 15 mg or 30 mg

    Percentage of participants initiating upadacitinib at 15 mg or 30 mg with rationale.

    Measured: Baseline

  59. Percentage of Participants with Modification of Upadacitinib Therapy, Timing of Modifications, and Reasons for Modifications

    This includes change in upadacitinib dose with rationale, e.g., dose change, temporary or permanent discontinuation.

    Measured: 24 Months

  60. Percentage of Participants with Modification of Concomitant AD Therapy, Timing of Modifications, and Reasons for Modifications

    This includes change in concomitant AD therapy with rationale, e.g., adding or removing or changing dose of topical corticosteroids/topical calcineurin inhibitors.

    Measured: 24 Months

  61. Absolute Score for Skin Pain on the Atopic Dermatitis Symptom Scale (ADerm-SS)

    Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being "no skin pain"/"no skin cracking" and 10 bring the "worst imaginable skin pain"/"worst imaginable skin cracking".

    Measured: Up to 24 Months

  62. Percent Change from Baseline for Skin Pain on the ADerm-SS

    Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being "no skin pain"/"no skin cracking" and 10 bring the "worst imaginable skin pain"/"worst imaginable skin cracking".

    Measured: Up to 24 Months

  63. Absolute Change from Baseline for Skin Pain on the ADerm-SS

    Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being "no skin pain"/"no skin cracking" and 10 bring the "worst imaginable skin pain"/"worst imaginable skin cracking".

    Measured: Up to 24 Months

  64. Absolute Score for Skin Cracking on the ADerm-SS

    Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being "no skin pain"/"no skin cracking" and 10 bring the "worst imaginable skin pain"/"worst imaginable skin cracking".

    Measured: Up to 24 Months

  65. Absolute Change from Baseline for Skin Cracking on the ADerm-SS

    Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being "no skin pain"/"no skin cracking" and 10 bring the "worst imaginable skin pain"/"worst imaginable skin cracking".

    Measured: Up to 24 Months

  66. Percent Change from Baseline for Skin Cracking on the ADerm-SS

    Skin pain and skin cracking are assessed by a one item test from the ADERM-SS to measure the intensity of skin pain/skin cracking during the past 24 hours. The test uses a scale of 0 to 10, with 0 being "no skin pain"/"no skin cracking" and 10 bring the "worst imaginable skin pain"/"worst imaginable skin cracking".

    Measured: Up to 24 Months

  67. Absolute Score for Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) of Hand Eczema

    The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe.

    Measured: Up to 24 Months

  68. Absolute Change from Baseline for vIGA-AD of Hand Eczema

    The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe.

    Measured: Up to 24 Months

  69. Percent Change from Baseline for vIGA-AD of Hand Eczema

    The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe.

    Measured: Up to 24 Months

  70. Absolute Score for vIGA-AD of Facial Eczema

    The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe.

    Measured: Up to 24 Months

  71. Absolute Change from Baseline for vIGA-AD of Facial Eczema

    The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe.

    Measured: Up to 24 Months

  72. Percent Change from Baseline for vIGA-AD of Facial Eczema

    The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. It consists of a 5-point scale used by the investigator to measure the severity of disease ranging from 0 - Clear to 4 - Severe.

    Measured: Up to 24 Months

  73. Absolute Score for Pruritis (5-D Pruritis Scale)

    The 5-D pruritis scale is a brief but multidimensional questionnaire for the quantification of pruritis that is sensitive to change over time. The five dimensions are degree, duration, direction, disability and distribution. The duration, degree and direction domains each include one item, while the disability domain has four items. All items on the first four domains are measured on a five-point Likert scales. The scores of each of the five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritis) and 25 (most severe pruritis).

    Measured: Up to 24 Months

  74. Absolute Change from Baseline for Pruritis (5-D Pruritis Scale)

    The 5-D pruritis scale is a brief but multidimensional questionnaire for the quantification of pruritis that is sensitive to change over time. The five dimensions are degree, duration, direction, disability and distribution. The duration, degree and direction domains each include one item, while the disability domain has four items. All items on the first four domains are measured on a five-point Likert scales. The scores of each of the five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritis) and 25 (most severe pruritis).

    Measured: Up to 24 Months

  75. Percent Change from Baseline for Pruritis (5-D Pruritis Scale)

    The 5-D pruritis scale is a brief but multidimensional questionnaire for the quantification of pruritis that is sensitive to change over time. The five dimensions are degree, duration, direction, disability and distribution. The duration, degree and direction domains each include one item, while the disability domain has four items. All items on the first four domains are measured on a five-point Likert scales. The scores of each of the five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritis) and 25 (most severe pruritis).

    Measured: Up to 24 Months

  76. Absolute Score for Flare Frequency

    Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. Additionally, the presence of a current flare is assessed at each visit.

    Measured: Up to 24 Months

  77. Absolute Change from Baseline for Flare Frequency

    Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. Additionally, the presence of a current flare is assessed at each visit.

    Measured: Up to 24 Months

  78. Percent Change from Baseline for Flare Frequency

    Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. Additionally, the presence of a current flare is assessed at each visit.

    Measured: Up to 24 Months

  79. Absolute Score for Flare Duration

    Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. The mean duration of the flares is also documented. Additionally, the presence of a current flare is assessed at each visit.

    Measured: Up to 24 Months

  80. Absolute Change from Baseline for Flare Duration

    Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. The mean duration of the flares is also documented. Additionally, the presence of a current flare is assessed at each visit.

    Measured: Up to 24 Months

  81. Percent Change from Baseline for Flare Duration

    Flare frequency is assessed by acquiring information about the number of flares in the last six months before baseline. During the study the patient is asked about number of flares since the last visit. The mean duration of the flares is also documented. Additionally, the presence of a current flare is assessed at each visit.

    Measured: Up to 24 Months

  82. Absolute Score for Patient Self-Reported Global Assessment of Disease Severity (PtGA)

    Patients assess the overall severity of their disease by a five-point assessment scale (clear, mild, moderate, severe, or very severe, [0-4]), with higher scores corresponding to greater severity.

    Measured: Up to 24 Months

  83. Absolute Change from Baseline for PtGA

    Patients assess the overall severity of their disease by a five-point assessment scale (clear, mild, moderate, severe, or very severe, [0-4]), with higher scores corresponding to greater severity.

    Measured: Up to 24 Months

  84. Percent Change from Baseline for PtGA

    Patients assess the overall severity of their disease by a five-point assessment scale (clear, mild, moderate, severe, or very severe, [0-4]), with higher scores corresponding to greater severity.

    Measured: Up to 24 Months

  85. Percentage of Participants Achieving PtGA <=2

    Patients assess the overall severity of their disease by a five-point assessment scale (clear, mild, moderate, severe, or very severe, [0-4]), with higher scores corresponding to greater severity.

    Measured: Up to 24 Months

  86. Percentage of Participants Achieving PtGA Reduction >=1 from Baseline

    Patients assess the overall severity of their disease by a five-point assessment scale (clear, mild, moderate, severe, or very severe, [0-4]), with higher scores corresponding to greater severity.

    Measured: Up to 24 Months

  87. Incidence and Type of Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug but within 30 days after the last dose of study drug.

    Measured: Up to 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2021
  2. Study start13 Dec 2021
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
634 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05139836
Sponsor's protocol ID
P21-705
Acronym
UP-TAINED
Status last verified
Aug 2026
First submitted
29 Nov 2021
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lauffer F, Bauer B, Kreutzer K, Schakel K, Schwichtenberg U, Hockmann J, Pinter A, Abousamra F, Huber M, Weidinger S. Real-World Evidence for the Impact of Minimal Disease Activity on Quality of Life in Atopic Dermatitis: An Interim Analysis of the Prospective, Multicenter, Non-Interventional UP-TAINED Study. Dermatol Ther (Heidelb). 2026 Jul 30. doi: 10.1007/s13555-026-01855-2. Online ahead of print.

    PubMed 42533213
  • 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.

    PubMed 40087231

Questions about this trial

What is this clinical trial studying?

An observational study of Atopic Dermatitis, run by AbbVie at 125 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Disease Control Defined by Atopic Dermatitis Control Tool (ADCT) Total Score <7 Points (time frame: Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05139836, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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