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.
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
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.
- Conditions
- Atopic Dermatitis
- 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 group | Role | What they receive |
|---|---|---|
| Participants Receiving Upadacitinib | Participants 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.
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
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)
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted1 Dec 2021
- Study start13 Dec 2021
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
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 42533213Weidinger 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05139836
- Acronym / sponsor ID
- UP-TAINED / P21-705
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis (AD), Upadacitinib, RINVOQ
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 634 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving Upadacitinib | – | –Participants receiving upadacitinib for moderate to severe atopic dermatitis. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Current participation in interventional research (note: this does not include non-interventional, post-marketing observational studies, or registry participation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Achieving Disease Control Defined by Atopic Dermatitis Control Tool (ADCT) Total Score <7 Points
Time frame: 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.
Percentage of Participants Achieving Disease Control Defined by ADCT Total Score <7 Points Among Participants Who Achieved Disease Control at Month 3
Time frame: Month 24
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.
87 secondary outcomes
Percentage of Participants Achieving Disease Control Defined by ADCT Total Score <7 Points
Time frame: Up to 24 Months
Percentage of Participants with An ADCT Total Score Reduction >=5 from Baseline
Time frame: 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
Time frame: 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
Time frame: Up to 21 Months (Excluding Month 3 - Primary Endpoint)
Absolute Score for ADCT Total Score
Time frame: Up to 24 Months
Absolute Change from Baseline for ADCT Total Score
Time frame: Up to 24 Months
Time to Achieve ADCT Total Score Reduction >=5 Points from Baseline
Time frame: Up to 24 Months
Time to Achieve Disease Control as Defined by ADCT Total Score <7 Points
Time frame: Up to 24 Months
Percent Change from Baseline for ADCT Total Score
Time frame: Up to 24 Months
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 50
Time frame: Up to 24 Months
Percentage of Participants Achieving EASI 75
Time frame: Up to 24 Months
Percentage of Participants Achieving EASI 90
Time frame: Up to 24 Months
Percentage of Participants Achieving EASI 100
Time frame: Up to 24 Months
Percentage of Participants Achieving Absolute EASI <=7
Time frame: Up to 24 Months
Absolute Score for EASI
Time frame: Up to 24 Months
Absolute Change from Baseline for EASI
Time frame: Up to 24 Months
Percent Change from Baseline for EASI
Time frame: Up to 24 Months
Time to Achieve EASI 50
Time frame: Up to 24 Months
Time to Achieve EASI 75
Time frame: Up to 24 Months
Time to Achieve EASI 90
Time frame: Up to 24 Months
Time to Achieve EASI 100
Time frame: Up to 24 Months
Time to Achieve Absolute EASI <=7
Time frame: Up to 24 Months
Percentage of Participants Achieving EASI 50 in the Head and/or Neck Body Region
Time frame: Up to 24 Months
Percentage of Participants Achieving EASI 75 in the Head and/or Neck Body Region
Time frame: Up to 24 Months
Percentage of Participants Achieving EASI 90 in the Head and/or Neck Body Region
Time frame: Up to 24 Months
Percentage of Participants Achieving EASI 100 in the Head and/or Neck Body Region
Time frame: Up to 24 Months
Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) <=1
Time frame: Up to 24 Months
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) <=1
Time frame: Up to 24 Months
Percentage of Participants Achieving WP-NRS <=3
Time frame: Up to 24 Months
Percentage of Participants Achieving a WP-NRS Reduction >=4 from Baseline
Time frame: Up to 24 Months
Absolute Score for WP-NRS
Time frame: Up to 24 Months
Absolute Change from Baseline for WP-NRS
Time frame: Up to 24 Months
Percent Change from Baseline for WP-NRS
Time frame: Up to 24 Months
Time to Achieve WP-NRS <=1
Time frame: Up to 24 Months
Absolute Score for Score Atopic Dermatitis (SCORAD) Sleep Visual Analog Scale (VAS)
Time frame: Up to 24 Months
Absolute Change from Baseline for SCORAD Sleep VAS
Time frame: Up to 24 Months
Percent Change from Baseline for SCORAD Sleep VAS
Time frame: Up to 24 Months
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI)/Children's Dermatology Life Quality Index (cDLQI) <=1
Time frame: Up to 24 Months
Percentage of Participants Achieving DLQI/cDLQI <=5
Time frame: Up to 24 Months
Percentage of Participants Achieving DLQI/cDLQI Reduction >=4 from Baseline
Time frame: Up to 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Derived from this study: PubMed 42533213Lauffer 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.
- Derived from this study: PubMed 40087231Weidinger 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.
- This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
125 sites in 1 country: see every site and its status.
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.