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

Atopic Dermatitis Clinical Trial

— UPDATE  

Official title:

Real-world Effectiveness and Use of UPaDAcitinib in Patients With moderaTE-to-severe Atopic Dermatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05669794
• Other study ID #: P23-628
• Status: Recruiting
• Start date: February 21, 2023
• Est. completion date: February 10, 2027

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 10, 2027
• Est. primary completion date: February 10, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
France	Hopital Nord Amiens /ID# 250300	Amiens
France	Chu Angers /Id# 248674	Angers
France	Hopital Prive d'Antony /ID# 247324	Antony	Ile-de-France
France	CH Victor Dupouy /ID# 247216	Argenteuil
France	CH Avignon /ID# 251198	Avignon	Vaucluse
France	CHU de Besancon - Jean Minjoz /ID# 248642	Besancon	Doubs
France	Centre Hospitalier de Béziers /ID# 264454	Béziers
France	Hopital Ambroise Pare /ID# 253337	Boulogne Billancourt
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	Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 252012	Chambery CEDEX	Savoie
France	CHU Clermont-Ferrand /ID# 248611	Clermont	Auvergne-Rhone-Alpes
France	Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 247209	Creteil	Paris
France	CHU Dijon /ID# 248984	Dijon	Cote-d Or
France	CH Annecy Genevois - Site Annecy /ID# 249024	Epagny Metz Tessy
France	CH la Rochelle /ID# 252128	La Rochelle CEDEX 1
France	Centre Hospitalier du Mans /ID# 250510	Le Mans CEDEX 9	Sarthe
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	Hopital du Scorff /ID# 251226	Lorient	Morbihan
France	Hopital Femme Mere Enfant /ID# 258682	Lyon
France	Hôpital Européen Marseille /ID# 257643	Marseille
France	Hopital Saint Joseph /ID# 255537	Marseille	Bouches-du-Rhone
France	CHU Montpellier - Hopital Saint Eloi /ID# 251877	Montpellier Cedex 5	Herault
France	CHU de Nantes, Hotel Dieu -HME /ID# 262563	Nantes	Pays-de-la-Loire
France	Cideazur /ID# 247905	Nice
France	CH Georges Renon /ID# 248976	Niort CEDEX	Deux-Sevres
France	Cabinet libéral du Dr KURIHARA /ID# 249664	Paris
France	Hopital Bichat-Claude Bernard /ID# 251274	Paris
France	Hopital Pitie Salpetriere /ID# 253464	Paris
France	Hopital Saint Louis /ID# 251228	Paris
France	Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 250807	Paris CEDEX 14	Paris
France	CH de PAU /ID# 248567	Pau
France	HCL - Hopital Lyon Sud /ID# 248864	Pierre Benite CEDEX	Rhone
France	CH Pontoise - Hopital René Dubos /ID# 248843	Pontoise	Val-d Oise
France	Centre Hospitalier de Quimper /ID# 251119	Quimper CEDEX	Finistere
France	Polyclinique Courlancy /ID# 250476	Reims	Marne
France	Hopital Ponchaillou /ID# 251225	Rennes	Bretagne
France	Hopitaux Drome Nord /ID# 248207	Romans Sur Isere	Drome
France	Hôpital Charles-Nicolle /ID# 247215	Rouen
France	CHU de Rouen /ID# 250648	Rouen CEDEX
France	CH de St Nazaire /ID# 251200	Saint Nazaire
France	Hôpital d'instruction des armées Bégin /ID# 247751	Saint-Mandé cedex
France	Ch Salon de Provence /Id# 248829	Salon de Provence
France	CHU nord - hopital Felix Guyon /ID# 250694	St Denis	Le Reunion
France	CHI POISSY - Saint-Germain-en-Laye /ID# 248612	St Germain en Laye	Yvelines
France	Ch Saint Quentin /Id# 249270	St Quentin CEDEX	Aisne
France	Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 251117	St-Priest-en-Jarez
France	CHR Metz-Thionville - Hopital Bel-Air /ID# 252267	Thionville
France	Hôpital d'Instruction des Armées Sainte-Anne /ID# 247908	Toulon CEDEX 9
France	CHU Toulouse - Hopital Larrey /ID# 247219	Toulouse
France	Hopital Nord Franche Comté /ID# 261628	Trevenans
France	CH Valence /ID# 250693	Valence	Drome
France	Centre Hospitalier de Valenciennes /ID# 258642	Valenciennes	Nord
France	Cabinet Liberal /ID# 251195	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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