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
- Conditions
- Atopic Dermatitis
- Registration Number
- NCT05669794
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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) who have been informed verbally and in writing about this study before inclusion, and who do not object to their data being processed.
- Participants (and legal representatives for adolescents) able to understand and communicate with the investigator.
- Participation in a clinical trial assessing an investigational drug, concurrently or within the last 30 days.
- Prior treatment with upadacitinib.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants achieving an absolute SCORing Atopic Dermatitis (SCORAD) of <25 Month 4 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (59)
Hopital Pitie Salpetriere /ID# 253464
🇫🇷Paris, Ile-de-France, France
CHU nord - hopital Felix Guyon /ID# 250694
🇫🇷St Denis, Le Reunion, France
Centre Hospitalier Saint-Nazaire /ID# 251200
🇫🇷Saint-Nazaire, Loire-Atlantique, France
Hôpital d'instruction des armées Bégin /ID# 247751
🇫🇷Saint-Mandé cedex, France
Ch Salon de Provence /Id# 248829
🇫🇷Salon de Provence, France
Hôpital d'Instruction des Armées Sainte-Anne /ID# 247908
🇫🇷Toulon CEDEX 9, France
Hopital Femme Mere Enfant /ID# 258682
🇫🇷Lyon, France
Cideazur /ID# 247905
🇫🇷Nice, France
Hôpital Saint-Louis /ID# 251228
🇫🇷Paris, France
Cabinet libéral du Dr KURIHARA /ID# 249664
🇫🇷Paris, France
Hopital Bichat-Claude Bernard /ID# 251274
🇫🇷Paris, France
CH de PAU /ID# 248567
🇫🇷Pau, France
CHU de Rouen /ID# 250648
🇫🇷Rouen CEDEX, France
Hôpital Charles-Nicolle /ID# 247215
🇫🇷Rouen, France
Cabinet Liberal /ID# 251195
🇫🇷Villeurbanne, France
Hopital Prive d'Antony /ID# 247324
🇫🇷Antony, Ile-de-France, France
CHU Montpellier - Hopital Saint Eloi /ID# 251877
🇫🇷Montpellier Cedex 5, Herault, France
CHU Toulouse - Hopital Larrey /ID# 247219
🇫🇷Toulouse, France
Hopital Nord Franche Comté /ID# 261628
🇫🇷Trevenans, France
Ch Saint Quentin /Id# 249270
🇫🇷St Quentin CEDEX, Aisne, France
CHU Clermont-Ferrand /ID# 248611
🇫🇷Clermont, Auvergne-Rhone-Alpes, France
Hôpital Européen Marseille /ID# 257643
🇫🇷Marseille, Bouches-du-Rhone, France
Hopital Saint Joseph /ID# 255537
🇫🇷Marseille, Bouches-du-Rhone, France
Hopital Ponchaillou /ID# 251225
🇫🇷Rennes, Bretagne, France
CHU Dijon /ID# 248984
🇫🇷Dijon, Cote-d Or, France
CH Georges Renon /ID# 248976
🇫🇷Niort CEDEX, Deux-Sevres, France
CHU de Besancon - Jean Minjoz /ID# 248642
🇫🇷Besancon, Doubs, France
Hopitaux Drome Nord /ID# 248207
🇫🇷Romans Sur Isere, Drome, France
CH Valence /ID# 250693
🇫🇷Valence, Drome, France
Centre Hospitalier de Quimper /ID# 251119
🇫🇷Quimper CEDEX, Finistere, France
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 251117
🇫🇷St-Priest-en-Jarez, Loire, France
Polyclinique Courlancy /ID# 250476
🇫🇷Reims, Marne, France
Hopital du Scorff /ID# 251226
🇫🇷Lorient, Morbihan, France
CHR Metz-Thionville - Hopital Bel-Air /ID# 252267
🇫🇷Thionville, Moselle, France
Centre Hospitalier de Valenciennes /ID# 258642
🇫🇷Valenciennes, Nord, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 247209
🇫🇷Creteil, Paris, France
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 250807
🇫🇷Paris CEDEX 14, Paris, France
CHU de Nantes, Hotel Dieu -HME /ID# 262563
🇫🇷Nantes, Pays-de-la-Loire, France
HCL - Hopital Lyon Sud /ID# 248864
🇫🇷Pierre Benite CEDEX, Rhone, France
Centre Hospitalier du Mans /ID# 250510
🇫🇷Le Mans CEDEX 9, Sarthe, France
Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 252012
🇫🇷Chambery CEDEX, Savoie, France
CH Pontoise - Hopital René Dubos /ID# 248843
🇫🇷Pontoise, Val-d Oise, France
CH Avignon /ID# 251198
🇫🇷Avignon, Vaucluse, France
CHI POISSY - Saint-Germain-en-Laye /ID# 248612
🇫🇷St Germain en Laye, Yvelines, France
Hopital Nord Amiens /ID# 250300
🇫🇷Amiens, France
Chu Angers /Id# 248674
🇫🇷Angers, France
CH Victor Dupouy /ID# 247216
🇫🇷Argenteuil, France
Hopital Ambroise Pare /ID# 253337
🇫🇷Boulogne Billancourt, France
Centre Hospitalier de Béziers /ID# 264454
🇫🇷Béziers, France
CHU de CAEN - Hopital de la Cote de Nacre /ID# 252127
🇫🇷Caen, France
CH de Cahors /ID# 251190
🇫🇷Cahors CEDEX 9, France
Centre Hospitalier de Calais /ID# 249449
🇫🇷Calais, France
Cabinet Dermatologie et Esthetique /ID# 247972
🇫🇷Cannes, France
CH William Morey /ID# 256417
🇫🇷Chalon Sur Saone, France
CH Annecy Genevois - Site Annecy /ID# 249024
🇫🇷Epagny Metz Tessy, France
CH la Rochelle /ID# 252128
🇫🇷La Rochelle CEDEX 1, France
CH Emile Roux Le Puy en Velay /ID# 248983
🇫🇷Le Puy en Velay, France
Hopital Saint Vincent de Paul /ID# 247218
🇫🇷Lille Cedex, France
CHU Limoges - Dupuytren 2 /ID# 251224
🇫🇷Limoges, France