- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07741838
Effectiveness of Upadacitinib and Biologics for the Achievement of Minimal Disease Activity in Adults With Moderate-to-Severe Atopic Dermatitis (RAMpUp) (RAMpUp)
A Prospective, Observational Study to Evaluate the Effectiveness of Upadacitinib and Biologics on the Achievement of Minimal Disease Activity in Patients With Moderate-to-severe Atopic Dermatitis (RAMpUp)
Atopic dermatitis (AD) is a common, chronic, inflammatory skin disease with a significant impact on patients' health-related quality of life. In addition to skin lesions, patients often experience pruritis, often at night, which can result in scratching and frequent sleep disturbances. These impacts can subsequently contribute to mental health problems and diminished quality of life. This study aims to evaluate the real-world effectiveness of upadacitinib for the achievement of minimal disease activity and optimal treatment targets in relation to biological treatments in adults with moderate-to-severe atopic dermatitis.
This is a prospective, observational, cohort study to evaluate the effectiveness of upadacitinib and biologics in participants with moderate-to-severe atopic dermatitis. Upadacitinib is an approved selective and reversible JAK inhibitor for the treatment of atopic dermatitis. This study is non-interventional and observational in design. Participants will be prescribed either upadacitinib or an approved biologic treatment for AD as per local country label and prescribing guidelines by their physician independent of study participation. Adult participants with moderate-to-severe AD who are biologic-naive or biologic-experienced will be enrolled. Around 900 participants will be enrolled in the study at multiple sites worldwide.
The study will follow participants for 48 weeks with recommended assessments. The treatment regimen, including route, form, and frequency, will be determined by the physician's usual clinical practice and local prescribing guidelines.
There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Meerat Oza
- Numéro de téléphone: 844-663-3742
- E-mail: meerat.oza@abbvie.com
Sauvegarde des contacts de l'étude
- Nom: Meerat Oza
- E-mail: meerat.oza@abbvie.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Physician confirmed diagnosis of moderate-to-severe AD validated Investigator's Global Assessment (vIGA-AD ≥ 3) with onset of symptoms ≥ 1 year prior to baseline
- Biologic-naive or biologic-experienced (use of a biologic treatment for AD within 2 years prior to the baseline visit)
- Participants initiating upadacitinib or an approved biologic treatment for AD per local label and local prescription guidelines
- Participants who are willing and able to complete the patient reported questionnaires
- Participants must voluntarily sign and date an informed consent form approved by an IEC/IRB prior to inclusion in this study (as per local regulations).
Exclusion Criteria:
- Participation in any interventional trial or observational study (not restricted to AD). Participation in a registry is permitted.
- Prior use of the AD treatment being evaluated in the study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
Upadacitinib
Participants initiating upadacitinib for the management of moderate-to-severe atopic dermatitis per local country label and physician decision.
Treatment prescribed in accordance with the terms of local country authorization and professional and reimbursement guidelines.
|
|
Biologics
Participants initiating approved biologic treatments for moderate-to-severe atopic dermatitis per local country label and physician decision.
Treatment prescribed in accordance with the terms of local country authorization and professional and reimbursement guidelines.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants Achieving Minimal Disease Activity (MDA)
Délai: At Week 16
|
Achievement of MDA defined as Eczema Area and Severity Index (EASI ≤ 3) and Worst Pruritus Numerical Rating Scale (WP-NRS) 0/1. The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD: Clear=0, Almost clear=0.1-1.0, Mild=1.1-7.0, Moderate=7.1-21.0, Severe=21.1-50.0, Very severe=50.1-72.0 Worst Pruritus NRS (WP-NRS) is a validated single self-reported measure where patients rate the worst level of itching they have experienced over the past 24 hours on a scale from 0 (no itching) to 10 (worst itching imaginable) |
At Week 16
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: ABBVIE INC., AbbVie
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies génétiques, innées
- Maladies du système immunitaire
- Hypersensibilité immédiate
- Hypersensibilité
- Maladies de la peau
- Maladies de la peau, Génétique
- Maladies de la peau, eczémateux
- Dermatite
- Maladies et anomalies congénitales, héréditaires et néonatales
- Maladies de la peau et du tissu conjonctif
- Dermatite atopique
Autres numéros d'identification d'étude
- P26-178
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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