Assessing the effectiveness of Upadacitinib for treating atopic dermatitis in adolescents and adults
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
This study tests how well the oral medication Upadacitinib works for treating moderate to severe atopic dermatitis in teenagers and adults who are already using it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 772 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | Upadacitinib |
| Locations | 125 sites (Heidelberg, Baden-Wuerttemberg and 124 other locations) |
| Trial ID | NCT05139836 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the real-world effectiveness of oral Upadacitinib in treating moderate to severe atopic dermatitis in adolescents and adults. It aims to assess disease activity and response patterns among participants who have been prescribed Upadacitinib prior to enrollment. Approximately 772 participants will be enrolled across up to 200 sites in Germany, providing insights into the medication's utilization in clinical practice.
Who should consider this trial
Good fit: Ideal candidates include adolescents and adults aged 12 years and older with a physician-confirmed diagnosis of moderate to severe atopic dermatitis.
Not a fit: Patients currently participating in interventional research may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the effectiveness of Upadacitinib, leading to improved treatment strategies for patients with atopic dermatitis.
How similar studies have performed: Other studies have shown success with similar approaches in evaluating real-world effectiveness of treatments for atopic dermatitis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Body weight \>=30 kg at baseline for participants between \>=12 and \<18 years of age. * Physician confirmed diagnosis of moderate to severe atopic dermatitis at the time of enrollment. * Upadacitinib initiated as per the local label. The decision to prescribe upadacitinib must have been made prior to and independently of study participation. * Medical and medication history available at least for the last 6 months. Exclusion Criteria: - Current participation in interventional research (note: this does not include non-interventional, post-marketing observational studies, or registry participation).
Where this trial is running
Heidelberg, Baden-Wuerttemberg and 124 other locations
- Durani & Durani, Heidelberg,DE /ID# 249172 — Heidelberg, Baden-Wuerttemberg, Germany (Recruiting)
- Universitaetsklinik Heidelberg /ID# 245834 — Heidelberg, Baden-Wuerttemberg, Germany (Recruiting)
- Hautarztpraxis Langenau /ID# 242279 — Langenau, Baden-Wuerttemberg, Germany (Recruiting)
- Flegl MD Stuttgart Germany /ID# 250302 — Stuttgart, Baden-Wuerttemberg, Germany (Completed)
- Kurzen, Freising, DE /ID# 241845 — Freising, Bayern, Germany (Recruiting)
- Beldio Research GmbH /ID# 245830 — Memmingen, Bayern, Germany (Completed)
- Dermazent /Id# 268146 — Munich, Bayern, Germany (Recruiting)
- Voelkel, Nuremberg, DE /ID# 252445 — Nuremberg, Bayern, Germany (Recruiting)
- Hautarzte im Novum Medicum Dr. Kreienkamp & Sautter /ID# 276060 — Wuerzburg, Bayern, Germany (Recruiting)
- Praxis Dres. Freitag/Knoell /ID# 242278 — Falkensee, Brandenburg, Germany (Recruiting)
- Dermatologie Kleinmachnow /ID# 268383 — Kleinmachnow, Brandenburg, Germany (Recruiting)
- Praxis Dr. Behnke /ID# 248870 — Panketal, Brandenburg, Germany (Recruiting)
- Praxis Dr. Asadullah /ID# 243944 — Potsdam, Brandenburg, Germany (Recruiting)
- Hautärzte am Nauener Tor /ID# 261533 — Potsdam, Brandenburg, Germany (Recruiting)
- Hautarztpraxis Dr. Alexander Magerl /ID# 270749 — Bensheim, Hessen, Germany (Completed)
- Universitaetsklinikum Frankfurt /ID# 241766 — Frankfurt am Main, Hessen, Germany (Recruiting)
- MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 243328 — Oberursel, Hessen, Germany (Recruiting)
- MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 249180 — Oberursel, Hessen, Germany (Recruiting)
- Hautcentrum Wiesbaden /ID# 274848 — Wiesbaden, Hessen, Germany (Recruiting)
- Herrmann, Greifswald, DE /ID# 241889 — Greifswald, Mecklenburg-Vorpommern, Germany (Recruiting)
- Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 241658 — Bramsche, Niedersachsen, Germany (Recruiting)
- Praxis Dres. Kaspari /Schenck /ID# 241688 — Hannover, Niedersachsen, Germany (Recruiting)
- Hoeller-Obrigkeit, Aachen, DE /ID# 245430 — Aachen, Nordrhein-Westfalen, Germany (Recruiting)
- Klinikum Rosenhoehe /ID# 241601 — Bielefeld, Nordrhein-Westfalen, Germany (Recruiting)
- Katholisches Klinikum Bochum gGmbH /ID# 270537 — Bochum, Nordrhein-Westfalen, Germany (Recruiting)
- Kramer/Mortazawi, Remscheid /ID# 241824 — Remscheid, Nordrhein-Westfalen, Germany (Recruiting)
- Karl, Soest, DE /ID# 241909 — Soest, Nordrhein-Westfalen, Germany (Recruiting)
- Bell, Andernach, DE /ID# 249154 — Andernach, Rheinland-Pfalz, Germany (Recruiting)
- Grossmann, Koblenz, DE /ID# 242992 — Koblenz, Rheinland-Pfalz, Germany (Recruiting)
- Hautarztpraxis Dr. Kirschner /ID# 266738 — Mainz, Rheinland-Pfalz, Germany (Recruiting)
- CMS3 Company for Medical Study /ID# 241659 — Selters, Rheinland-Pfalz, Germany (Recruiting)
- Dermatologisches Studienzentrum am Haut- und Laserzentrum /ID# 243882 — Simmern, Rheinland-Pfalz, Germany (Recruiting)
- HMS GmbH Zimmer /ID# 241657 — Merzig, Saarland, Germany (Recruiting)
- Praxis Dr. Raschke /ID# 251398 — Magdeburg, Sachsen-Anhalt, Germany (Recruiting)
- Praxis P. Hausler-Mehlhorn /ID# 241527 — Chemnitz, Sachsen, Germany (Recruiting)
- Neubauer, Leipzig, DE /ID# 241823 — Leipzig, Sachsen, Germany (Recruiting)
- Praxis Dr. Mempel /ID# 241827 — Elmshorn, Schleswig-Holstein, Germany (Recruiting)
- Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 240096 — Kiel, Schleswig-Holstein, Germany (Recruiting)
- Dermatologie Moelln Praxis Dr. Bodo Segert /ID# 242280 — Mölln, Schleswig-Holstein, Germany (Recruiting)
- Praxis Liebetrau /ID# 271896 — Friedrichroda, Thueringen, Germany (Recruiting)
- Petri, Ahaus, DE /ID# 243452 — Ahaus, Germany (Recruiting)
- Dr. Stoeber /ID# 251066 — Ahlen, Germany (Recruiting)
- Praxis Dr. Mihaescu /ID# 241825 — Augsburg, Germany (Recruiting)
- MVZ medicum.mittelhessen /ID# 266126 — Bad Camberg, Germany (Recruiting)
- Mauer, Bad Kreuznach, DE /ID# 241990 — Bad Kreuznach, Germany (Recruiting)
- Timmel/Timm/Vorwerk, Bergen /ID# 241661 — Bergen, Germany (Recruiting)
- Hautarztpraxis Dr. med. Christiane Handrick /ID# 262667 — Berlin, Germany (Recruiting)
- Praxis Dermatologie am Savigny /ID# 248846 — Berlin, Germany (Recruiting)
- Dre. Gellrich/Klein/Soost /ID# 250301 — Berlin, Germany (Recruiting)
- Schirmer, Berlin, DE /ID# 241684 — Berlin, Germany (Recruiting)
+75 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Medical Information Germany
- Email: medinfo.germany@abbvie.com
- Phone: 49 611 1720 1520
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.