Úprava PEST pro screening psoriatické artritidy (ScreenX)
Multicentrická prospektivní studie k vyhodnocení dopadu modifikace validovaného nástroje pro screening epidemiologie psoriázy (PEST) na potenciální diagnózu psoriatické artritidy u dospělých pacientů se středně těžkou až těžkou plakovou psoriázou v Kanadě ("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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Novartis Pharmaceuticals
- E-mail: novartis.email@novartis.com
Studijní záloha kontaktů
- Jméno: Novartis Pharmaceuticals
- Telefonní číslo: +41613241111
- E-mail: novartis.email@novartis.com
Studijní místa
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Alberta
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Calgary, Alberta, Kanada, T2J 7E1
- Nábor
- Novartis Investigative Site
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Edmonton, Alberta, Kanada, T6G 2C8
- Nábor
- Novartis Investigative Site
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Edmonton, Alberta, Kanada, T5J 3S9
- Nábor
- Novartis Investigative Site
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British Columbia
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Kelowna, British Columbia, Kanada, V1W 4V5
- Nábor
- Novartis Investigative Site
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Surrey, British Columbia, Kanada, V3R 6A7
- Nábor
- Novartis Investigative Site
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Manitoba
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Winnipeg, Manitoba, Kanada, R3C 0N2
- Nábor
- Novartis Investigative Site
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New Brunswick
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Fredericton, New Brunswick, Kanada, E3B 1G9
- Nábor
- Novartis Investigative Site
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Ontario
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Barrie, Ontario, Kanada, L4M 6L2
- Nábor
- Novartis Investigative Site
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Greater Sudbury, Ontario, Kanada, P3C 1X8
- Nábor
- Novartis Investigative Site
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Hamilton, Ontario, Kanada, L8N 1V6
- Nábor
- Novartis Investigative Site
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Hamilton, Ontario, Kanada, L8J 0G5
- Nábor
- Novartis Investigative Site
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Hamilton, Ontario, Kanada, L8P 4B4
- Nábor
- Novartis Investigative Site
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London, Ontario, Kanada, N6A 5R9
- Nábor
- Novartis Investigative Site
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London, Ontario, Kanada, N6G 0W7
- Nábor
- Novartis Investigative Site
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Markham, Ontario, Kanada, L3R 2C7
- Nábor
- Novartis Investigative Site
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Ottawa, Ontario, Kanada, K2A 3Z3
- Nábor
- Novartis Investigative Site
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Richmond Hill, Ontario, Kanada, L4C 9M7
- Nábor
- Novartis Investigative Site
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Stoney Creek, Ontario, Kanada, L8G 1H1
- Nábor
- Novartis Investigative Site
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Toronto, Ontario, Kanada, M4A 2S8
- Nábor
- Novartis Investigative Site
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Toronto, Ontario, Kanada, M5S 1B6
- Nábor
- Novartis Investigative Site
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Waterloo, Ontario, Kanada, N2J 1C4
- Nábor
- Novartis Investigative Site
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Quebec
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Montreal, Quebec, Kanada, H1T 2M4
- Nábor
- Novartis Investigative Site
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Montreal, Quebec, Kanada, H4A 3T2
- Nábor
- Novartis Investigative Site
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Montreal, Quebec, Kanada, H1Y 3L1
- Nábor
- Novartis Investigative Site
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Québec, Quebec, Kanada, G1W 4R4
- Nábor
- Novartis Investigative Site
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Québec, Quebec, Kanada, G1V 4X7
- Nábor
- Novartis Investigative Site
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Ste-Foy, Quebec, Kanada, G1V 4G2
- Nábor
- Novartis Investigative Site
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Verdun, Quebec, Kanada, H4G 3E7
- Nábor
- Novartis Investigative Site
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7K 2C1
- Nábor
- Novartis Investigative Site
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Saskatoon, Saskatchewan, Kanada, S7K 0H6
- Nábor
- Novartis Investigative Site
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Promítání
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Jiný: 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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CAIN457ACA06
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
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