An Observational Study to Assess Change in Disease Activity and Use of Upadacitinib Tablets in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis in Real World
UPDATE
Real-world Effectiveness and Use of UPaDAcitinib in Patients With moderaTE-to-severe Atopic Dermatitis
1 other identifier
observational
300
1 country
59
Brief Summary
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. This study will assess how effective upadacitinib is in treating AD. Upadacitinib is an approved drug for treating AD. Approximately 300 adolescent and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in France. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 24 months per participant and 30 days after last treatment dose for safety data collection. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
Longer than P75 for all trials
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2022
CompletedFirst Posted
Study publicly available on registry
January 3, 2023
CompletedStudy Start
First participant enrolled
February 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
February 27, 2025
February 1, 2025
3.9 years
December 21, 2022
February 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants achieving an absolute SCORing Atopic Dermatitis (SCORAD) of <25
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).
Month 4
Study Arms (1)
Upadacitinib
Participants will receive upadacitinib as prescribed by their physician according to local label.
Eligibility Criteria
Adolescent and adult participants with Atopic dermatitis (AD)
You may qualify if:
- Physician confirmed diagnosis of atopic dermatitis or atopic eczema at baseline.
- Symptom onset ≥1 year prior to baseline.
- Initiation of upadacitinib treatment for AD is indicated and prescribed per local label.
- The decision to prescribe upadacitinib is made prior to and independently of study participation.
- Participants who can understand and who are willing and able to complete the questionnaires, with parental support as required for adolescents.
- Participants (or legal representatives for adolescents) with a smartphone/tablet with internet access and willing to download the dedicated application to complete the questionnaires via this application.
- Participants (and legal representatives for adolescents) able to understand and communicate with the investigator.
You may not qualify if:
- Participation in a clinical trial assessing an investigational drug, concurrently or within the last 30 days.
- Prior treatment with upadacitinib.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (59)
Ch Saint Quentin /Id# 249270
Saint-Quentin, Aisne, 02321, France
CHU Clermont-Ferrand /ID# 248611
Clermont, Auvergne-Rhône-Alpes, 63100, France
Hôpital Européen Marseille /ID# 257643
Marseille, Bouches-du-Rhone, 13003, France
Hopital Saint Joseph /ID# 255537
Marseille, Bouches-du-Rhone, 13008, France
Hopital Ponchaillou /ID# 251225
Rennes, Brittany Region, 35000, France
CHU Dijon /ID# 248984
Dijon, Cote-d Or, 21000, France
CH Georges Renon /ID# 248976
Niort, Deux-Sevres, 79028, France
CHU de Besancon - Jean Minjoz /ID# 248642
Besançon, Doubs, 25030, France
Hopitaux Drome Nord /ID# 248207
Romans-sur-Isère, Drome, 26100, France
CH Valence /ID# 250693
Valence, Drome, 26000, France
Centre Hospitalier de Quimper /ID# 251119
Quimper, Finistere, 29107, France
CHU Montpellier - Hopital Saint Eloi /ID# 251877
Montpellier, Herault, 34295, France
CHU nord - hopital Felix Guyon /ID# 250694
Saint-Denis, Le Reunion, 97400, France
Centre Hospitalier Saint-Nazaire /ID# 251200
Saint-Nazaire, Loire-Atlantique, 44606, France
Polyclinique Courlancy /ID# 250476
Reims, Marne, 51100, France
Hopital du Scorff /ID# 251226
Lorient, Morbihan, 56100, France
CHR Metz-Thionville - Hopital Bel-Air /ID# 252267
Thionville, Moselle, 57100, France
Centre Hospitalier de Valenciennes /ID# 258642
Valenciennes, Nord, 59300, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 247209
Créteil, Paris, 94010, France
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 250807
Paris, Paris, 75679, France
CHU de Nantes, Hotel Dieu -HME /ID# 262563
Nantes, Pays de la Loire Region, 44000, France
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 251117
St-Priest-en-Jarez, Pays de la Loire Region, 42270, France
HCL - Hopital Lyon Sud /ID# 248864
Pierre-Bénite, Rhone, 69495, France
Centre Hospitalier du Mans /ID# 250510
Le Mans, Sarthe, 72037, France
Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 252012
Chambéry, Savoie, 73007, France
CH Pontoise - Hopital René Dubos /ID# 248843
Pontoise, Val-d Oise, 95300, France
CH Avignon /ID# 251198
Avignon, Vaucluse, 84902, France
CHI POISSY - Saint-Germain-en-Laye /ID# 248612
Saint-Germain-en-Laye, Yvelines, 78100, France
Hopital Nord Amiens /ID# 250300
Amiens, 80080, France
Chu Angers /Id# 248674
Angers, 49933, France
CH Victor Dupouy /ID# 247216
Argenteuil, 95100, France
Centre Hospitalier de Béziers /ID# 264454
Béziers, 34525, France
Hopital Ambroise Pare /ID# 253337
Boulogne-Billancourt, 92104, France
CHU de CAEN - Hopital de la Cote de Nacre /ID# 252127
Caen, 14033, France
CH de Cahors /ID# 251190
Cahors, 46005, France
Centre Hospitalier de Calais /ID# 249449
Calais, 62100, France
Cabinet Dermatologie et Esthetique /ID# 247972
Cannes, 06400, France
CH William Morey /ID# 256417
Chalon-sur-Saône, 71321, France
CH Annecy Genevois - Site Annecy /ID# 249024
Epagny Metz Tessy, 74370, France
CH la Rochelle /ID# 252128
La Rochelle, 17019, France
CH Emile Roux Le Puy en Velay /ID# 248983
Le Puy-en-Velay, 43000, France
Hopital Saint Vincent de Paul /ID# 247218
Lille, 59020, France
CHU Limoges - Dupuytren 2 /ID# 251224
Limoges, 87000, France
Hopital Femme Mere Enfant /ID# 258682
Lyon, 69500, France
Cideazur /ID# 247905
Nice, 06000, France
Hôpital Saint-Louis /ID# 251228
Paris, 75010, France
Cabinet libéral du Dr KURIHARA /ID# 249664
Paris, 75011, France
Hopital Bichat-Claude Bernard /ID# 251274
Paris, 75018, France
CH de PAU /ID# 248567
Pau, 64000, France
Hôpital Charles-Nicolle /ID# 247215
Rouen, 76000, France
CHU de Rouen /ID# 250648
Rouen, 76031, France
Hôpital d'instruction des armées Bégin /ID# 247751
Saint-Mandé, 94163, France
Ch Salon de Provence /Id# 248829
Salon-de-Provence, 13300, France
Hôpital d'Instruction des Armées Sainte-Anne /ID# 247908
Toulon, 83800, France
CHU Toulouse - Hopital Larrey /ID# 247219
Toulouse, 31400, France
Hopital Nord Franche Comté /ID# 261628
Trévenans, 90400, France
Cabinet Liberal /ID# 251195
Villeurbanne, 69100, France
Hopital Prive d'Antony /ID# 247324
Antony, Île-de-France Region, 92160, France
Hopital Pitie Salpetriere /ID# 253464
Paris, Île-de-France Region, 75013, France
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2022
First Posted
January 3, 2023
Study Start
February 21, 2023
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
February 27, 2025
Record last verified: 2025-02