Modifica PEST per lo screening dell'artrite psoriasica (ScreenX)
Uno studio multicentrico, prospettico, per valutare l'impatto della modifica dello strumento validato di screening epidemiologico della psoriasi (PEST) sulla potenziale diagnosi di artrite psoriasica in pazienti adulti con psoriasi a placche da moderata a grave in Canada ("ScreenX")
The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Patients will be enrolled in the study for up to 120 days and will be asked to fill-out a PsA screening questionnaire at their first dermatologist visit. Patients screening positive for PsA will have a second visit with a rheumatologist where a full PsA diagnosis assessment will be performed. A remote 'end of study' (EOS) visit will be conducted by the dermatologist to document the patient's biologic Disease-Modifying Antirheumatic Drugs (bDMARDs) treatment choice and status.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
Backup dei contatti dello studio
- Nome: Novartis Pharmaceuticals
- Numero di telefono: +41613241111
- Email: novartis.email@novartis.com
Luoghi di studio
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Alberta
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Calgary, Alberta, Canada, T2J 7E1
- Reclutamento
- Novartis Investigative Site
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Edmonton, Alberta, Canada, T6G 2C8
- Reclutamento
- Novartis Investigative Site
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Edmonton, Alberta, Canada, T5J 3S9
- Reclutamento
- Novartis Investigative Site
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British Columbia
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Kelowna, British Columbia, Canada, V1W 4V5
- Reclutamento
- Novartis Investigative Site
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Surrey, British Columbia, Canada, V3R 6A7
- Reclutamento
- Novartis Investigative Site
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Manitoba
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Winnipeg, Manitoba, Canada, R3C 0N2
- Reclutamento
- Novartis Investigative Site
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New Brunswick
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Fredericton, New Brunswick, Canada, E3B 1G9
- Reclutamento
- Novartis Investigative Site
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Ontario
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Barrie, Ontario, Canada, L4M 6L2
- Reclutamento
- Novartis Investigative Site
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Greater Sudbury, Ontario, Canada, P3C 1X8
- Reclutamento
- Novartis Investigative Site
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Hamilton, Ontario, Canada, L8N 1V6
- Reclutamento
- Novartis Investigative Site
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Hamilton, Ontario, Canada, L8J 0G5
- Reclutamento
- Novartis Investigative Site
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Hamilton, Ontario, Canada, L8P 4B4
- Reclutamento
- Novartis Investigative Site
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London, Ontario, Canada, N6A 5R9
- Reclutamento
- Novartis Investigative Site
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London, Ontario, Canada, N6G 0W7
- Reclutamento
- Novartis Investigative Site
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Markham, Ontario, Canada, L3R 2C7
- Reclutamento
- Novartis Investigative Site
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Ottawa, Ontario, Canada, K2A 3Z3
- Reclutamento
- Novartis Investigative Site
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Richmond Hill, Ontario, Canada, L4C 9M7
- Reclutamento
- Novartis Investigative Site
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Stoney Creek, Ontario, Canada, L8G 1H1
- Reclutamento
- Novartis Investigative Site
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Toronto, Ontario, Canada, M4A 2S8
- Reclutamento
- Novartis Investigative Site
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Toronto, Ontario, Canada, M5S 1B6
- Reclutamento
- Novartis Investigative Site
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Waterloo, Ontario, Canada, N2J 1C4
- Reclutamento
- Novartis Investigative Site
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Reclutamento
- Novartis Investigative Site
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Montreal, Quebec, Canada, H4A 3T2
- Reclutamento
- Novartis Investigative Site
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Montreal, Quebec, Canada, H1Y 3L1
- Reclutamento
- Novartis Investigative Site
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Québec, Quebec, Canada, G1W 4R4
- Reclutamento
- Novartis Investigative Site
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Québec, Quebec, Canada, G1V 4X7
- Reclutamento
- Novartis Investigative Site
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Ste-Foy, Quebec, Canada, G1V 4G2
- Reclutamento
- Novartis Investigative Site
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Verdun, Quebec, Canada, H4G 3E7
- Reclutamento
- Novartis Investigative Site
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 2C1
- Reclutamento
- Novartis Investigative Site
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Saskatoon, Saskatchewan, Canada, S7K 0H6
- Reclutamento
- Novartis Investigative Site
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Key inclusion criteria:
- Moderate-to-severe plaque PsO patients who are candidates for bDMARDs, according to physician's clinical judgement at the time of patient enrollment.
- Adult patients at the time of informed consent signature
- Patients able to understand and willing to comply with protocol requirements, instructions, and restrictions
- Residents of Canada
Key exclusion criteria:
- Patients who have previously screened positive for PsA through PEST.
- Patients who have been diagnosed with PsA.
- Patients who have been diagnosed with inflammatory arthritis unrelated to PsA (rheumatoid arthritis, reactive arthritis, enteropathic arthritis, axial spondyloarthritis)
- Patients treated with a bDMARD for moderate-to-severe plaque PsO or any other medical condition within the last 6 months prior to patient enrollment.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Selezione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: PEST Screening group
When visiting their dermatologists, all eligible patients with moderate-to-severe plaque psoriasis (PsO) eligible for treatment with biologic Disease-Modifying Antirheumatic Drugs (bDMARDs) will be screened for psoriatic arthritis (PsA) using PEST+pictures+2, a variation of the PEST screening tool. The PEST+pictures+2 is made up of 3 components:
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PEST Screening group |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Positive Predictive Value (PPV) for PEST and PEST+2 in adult patients with moderate-to-severe plaque PsO who are candidates for bDMARDs
Lasso di tempo: Up to approximately 1 year
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To assess the impact of adding two questions (morning stiffness and low back or buttock pain) to the validated PEST for the potential diagnosis of PsA in moderate-to-severe plaque PsO patients who are candidates for biologic disease-modifying antirheumatic drugs (bDMARDs) The primary clinical question of interest is: Can the addition of two questions to PEST pertaining to presence of morning stiffness and low back or buttock pain (i.e., PEST+2) allow for improved screening and diagnosis of PsA in patients with moderate-to-severe plaque PsO? |
Up to approximately 1 year
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Proportion of patients scoring negative on PEST and positive on PEST+2 with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist
Lasso di tempo: Up to approximately 1 year
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To estimate the proportion of patients with a confirmed or suspected PsA diagnosis referred by dermatologists using PEST+2 only |
Up to approximately 1 year
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Proportion of patients with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist
Lasso di tempo: Up to approximately 1 year
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Proportion of patients with a new PsA diagnosis or suspicion of PsA, confirmed by the rheumatologist who scored:
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Up to approximately 1 year
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Proportion of patients with a false positive score between each group
Lasso di tempo: Up to approximately 1 year
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Proportion of patients with false positive score between each group will be evaluated:
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Up to approximately 1 year
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Description of the baseline characteristics of the positive screening score and negative screening score patients for both PEST and PEST+2 tests
Lasso di tempo: Up to approximately 1 year
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Description of the baseline characteristics (i.e., patient age, biological sex, years since plaque PsO diagnosis, medical history, disease characteristics, concomitant treatments, height, weight, etc.) of the positive screening score and negative screening score patients for both PEST and PEST+2 tests will be evaluated to determine patient's baseline characteristics. |
Up to approximately 1 year
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Patient acceptability/user experience of the PEST+2 questionnaire
Lasso di tempo: Up to approximately 1 year
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Summary scores of the patient acceptability questionnaire of PsA screening questionnaires and a categorical presentation of question-by-question responses at Visit 1 |
Up to approximately 1 year
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Administration of dermatologist quantitative surveys
Lasso di tempo: Up to approximately 1 year
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Administration of dermatologist quantitative surveys, as well as open-ended qualitative questions to assess the acceptability and feasibility of the PEST+pictures+2 from the perspective of dermatologists |
Up to approximately 1 year
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Qualitative interview with selected dermatologists
Lasso di tempo: Up to approximately 1 year
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Brief 1:1 qualitative interview with selected dermatologists (maximum 12) to assess their knowledge, beliefs, and attitudes towards PsA screening (e.g., motivation to screen) |
Up to approximately 1 year
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Intervention Appropriateness Measure (IAM)
Lasso di tempo: Up to approximately 1 year
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To assess the appropriateness of the PEST+2 from the perspective of rheumatologists |
Up to approximately 1 year
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
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
Altri numeri di identificazione dello studio
- CAIN457ACA06
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Informazioni su farmaci e dispositivi, documenti di studio
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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 .