Clinical trial NCT05669794: 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
Official title: Real-world Effectiveness and Use of UPaDAcitinib in Patients With moderaTE-to-severe Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
AD
Upadacitinib
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-01-03
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescent and adult participants with Atopic dermatitis (AD)

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Participation in a clinical trial assessing an investigational drug, concurrently or within the last 30 days.
* Prior treatment with upadacitinib.

Primary outcomes:
measure: Percentage of Participants achieving an absolute SCORing Atopic Dermatitis (SCORAD) of <25
timeFrame: Month 4
Secondary outcomes:
Other outcomes:
Locations:
city: St Quentin CEDEX
country: France
facility: Ch Saint Quentin /Id# 249270
state: Aisne
city: Clermont
country: France
facility: CHU Clermont-Ferrand /ID# 248611
state: Auvergne-Rhone-Alpes
city: Marseille
country: France
facility: Hôpital Européen Marseille /ID# 257643
state: Bouches-du-Rhone
city: Marseille
country: France
facility: Hopital Saint Joseph /ID# 255537
state: Bouches-du-Rhone
city: Rennes
country: France
facility: Hopital Ponchaillou /ID# 251225
state: Bretagne
city: Dijon
country: France
facility: CHU Dijon /ID# 248984
state: Cote-d Or
city: Niort CEDEX
country: France
facility: CH Georges Renon /ID# 248976
state: Deux-Sevres
city: Besancon
country: France
facility: CHU de Besancon - Jean Minjoz /ID# 248642
state: Doubs
city: Romans Sur Isere
country: France
facility: Hopitaux Drome Nord /ID# 248207
state: Drome
city: Valence
country: France
facility: CH Valence /ID# 250693
state: Drome
city: Quimper CEDEX
country: France
facility: Centre Hospitalier de Quimper /ID# 251119
state: Finistere
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hopital Saint Eloi /ID# 251877
state: Herault
city: Antony
country: France
facility: Hopital Prive d'Antony /ID# 247324
state: Ile-de-France
city: Paris
country: France
facility: Hopital Pitie Salpetriere /ID# 253464
state: Ile-de-France
city: St Denis
country: France
facility: CHU nord - hopital Felix Guyon /ID# 250694
state: Le Reunion
city: Saint-Nazaire
country: France
facility: Centre Hospitalier Saint-Nazaire /ID# 251200
state: Loire-Atlantique
city: St-Priest-en-Jarez
country: France
facility: Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 251117
state: Loire
city: Reims
country: France
facility: Polyclinique Courlancy /ID# 250476
state: Marne
city: Lorient
country: France
facility: Hopital du Scorff /ID# 251226
state: Morbihan
city: Thionville
country: France
facility: CHR Metz-Thionville - Hopital Bel-Air /ID# 252267
state: Moselle
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes /ID# 258642
state: Nord
city: Creteil
country: France
facility: Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 247209
state: Paris
city: Paris CEDEX 14
country: France
facility: Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 250807
state: Paris
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 262563
state: Pays-de-la-Loire
city: Pierre Benite CEDEX
country: France
facility: HCL - Hopital Lyon Sud /ID# 248864
state: Rhone
city: Le Mans CEDEX 9
country: France
facility: Centre Hospitalier du Mans /ID# 250510
state: Sarthe
city: Chambery CEDEX
country: France
facility: Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 252012
state: Savoie
city: Pontoise
country: France
facility: CH Pontoise - Hopital René Dubos /ID# 248843
state: Val-d Oise
city: Avignon
country: France
facility: CH Avignon /ID# 251198
state: Vaucluse
city: St Germain en Laye
country: France
facility: CHI POISSY - Saint-Germain-en-Laye /ID# 248612
state: Yvelines
city: Amiens
country: France
facility: Hopital Nord Amiens /ID# 250300
city: Angers
country: France
facility: Chu Angers /Id# 248674
city: Argenteuil
country: France
facility: CH Victor Dupouy /ID# 247216
city: Boulogne Billancourt
country: France
facility: Hopital Ambroise Pare /ID# 253337
city: Béziers
country: France
facility: Centre Hospitalier de Béziers /ID# 264454
city: Caen
country: France
facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 252127
city: Cahors CEDEX 9
country: France
facility: CH de Cahors /ID# 251190
city: Calais
country: France
facility: Centre Hospitalier de Calais /ID# 249449
city: Cannes
country: France
facility: Cabinet Dermatologie et Esthetique /ID# 247972
city: Chalon Sur Saone
country: France
facility: CH William Morey /ID# 256417
city: Epagny Metz Tessy
country: France
facility: CH Annecy Genevois - Site Annecy /ID# 249024
city: La Rochelle CEDEX 1
country: France
facility: CH la Rochelle /ID# 252128
city: Le Puy en Velay
country: France
facility: CH Emile Roux Le Puy en Velay /ID# 248983
city: Lille Cedex
country: France
facility: Hopital Saint Vincent de Paul /ID# 247218
city: Limoges
country: France
facility: CHU Limoges - Dupuytren 2 /ID# 251224
city: Lyon
country: France
facility: Hopital Femme Mere Enfant /ID# 258682
city: Nice
country: France
facility: Cideazur /ID# 247905
city: Paris
country: France
facility: Hôpital Saint-Louis /ID# 251228
city: Paris
country: France
facility: Cabinet libéral du Dr KURIHARA /ID# 249664
city: Paris
country: France
facility: Hopital Bichat-Claude Bernard /ID# 251274
city: Pau
country: France
facility: CH de PAU /ID# 248567
city: Rouen CEDEX
country: France
facility: CHU de Rouen /ID# 250648
city: Rouen
country: France
facility: Hôpital Charles-Nicolle /ID# 247215
city: Saint-Mandé cedex
country: France
facility: Hôpital d'instruction des armées Bégin /ID# 247751
city: Salon de Provence
country: France
facility: Ch Salon de Provence /Id# 248829
city: Toulon CEDEX 9
country: France
facility: Hôpital d'Instruction des Armées Sainte-Anne /ID# 247908
city: Toulouse
country: France
facility: CHU Toulouse - Hopital Larrey /ID# 247219
city: Trevenans
country: France
facility: Hopital Nord Franche Comté /ID# 261628
city: Villeurbanne
country: France
facility: Cabinet Liberal /ID# 251195
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: