- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Meerat Oza
- Numero di telefono: 844-663-3742
- Email: meerat.oza@abbvie.com
Backup dei contatti dello studio
- Nome: Meerat Oza
- Email: meerat.oza@abbvie.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants Achieving Minimal Disease Activity (MDA)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: ABBVIE INC., AbbVie
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie genetiche, congenite
- Malattie del sistema immunitario
- Ipersensibilità, immediata
- Ipersensibilità
- Malattie della pelle
- Malattie della pelle, genetiche
- Malattie della pelle, eczematose
- Dermatite
- Malattie e anomalie congenite, ereditarie e neonatali
- Malattie della pelle e del tessuto connettivo
- Dermatite, atopica
Altri numeri di identificazione dello studio
- P26-178
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .