Modifizieren von PEST für das Psoriasis-Arthritis-Screening (ScreenX)
Eine multizentrische, prospektive Studie zur Bewertung der Auswirkungen einer Änderung des validierten Psoriasis-Epidemiologie-Screening-Tools (PEST) auf die potenzielle Diagnose von Psoriasis-Arthritis bei erwachsenen Patienten mit mittelschwerer bis schwerer Plaque-Psoriasis in Kanada („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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Novartis Pharmaceuticals
- E-Mail: novartis.email@novartis.com
Studieren Sie die Kontaktsicherung
- Name: Novartis Pharmaceuticals
- Telefonnummer: +41613241111
- E-Mail: novartis.email@novartis.com
Studienorte
-
-
Alberta
-
Calgary, Alberta, Kanada, T2J 7E1
- Rekrutierung
- Novartis Investigative Site
-
Edmonton, Alberta, Kanada, T6G 2C8
- Rekrutierung
- Novartis Investigative Site
-
Edmonton, Alberta, Kanada, T5J 3S9
- Rekrutierung
- Novartis Investigative Site
-
-
British Columbia
-
Kelowna, British Columbia, Kanada, V1W 4V5
- Rekrutierung
- Novartis Investigative Site
-
Surrey, British Columbia, Kanada, V3R 6A7
- Rekrutierung
- Novartis Investigative Site
-
-
Manitoba
-
Winnipeg, Manitoba, Kanada, R3C 0N2
- Rekrutierung
- Novartis Investigative Site
-
-
New Brunswick
-
Fredericton, New Brunswick, Kanada, E3B 1G9
- Rekrutierung
- Novartis Investigative Site
-
-
Ontario
-
Barrie, Ontario, Kanada, L4M 6L2
- Rekrutierung
- Novartis Investigative Site
-
Greater Sudbury, Ontario, Kanada, P3C 1X8
- Rekrutierung
- Novartis Investigative Site
-
Hamilton, Ontario, Kanada, L8N 1V6
- Rekrutierung
- Novartis Investigative Site
-
Hamilton, Ontario, Kanada, L8J 0G5
- Rekrutierung
- Novartis Investigative Site
-
Hamilton, Ontario, Kanada, L8P 4B4
- Rekrutierung
- Novartis Investigative Site
-
London, Ontario, Kanada, N6A 5R9
- Rekrutierung
- Novartis Investigative Site
-
London, Ontario, Kanada, N6G 0W7
- Rekrutierung
- Novartis Investigative Site
-
Markham, Ontario, Kanada, L3R 2C7
- Rekrutierung
- Novartis Investigative Site
-
Ottawa, Ontario, Kanada, K2A 3Z3
- Rekrutierung
- Novartis Investigative Site
-
Richmond Hill, Ontario, Kanada, L4C 9M7
- Rekrutierung
- Novartis Investigative Site
-
Stoney Creek, Ontario, Kanada, L8G 1H1
- Rekrutierung
- Novartis Investigative Site
-
Toronto, Ontario, Kanada, M4A 2S8
- Rekrutierung
- Novartis Investigative Site
-
Toronto, Ontario, Kanada, M5S 1B6
- Rekrutierung
- Novartis Investigative Site
-
Waterloo, Ontario, Kanada, N2J 1C4
- Rekrutierung
- Novartis Investigative Site
-
-
Quebec
-
Montreal, Quebec, Kanada, H1T 2M4
- Rekrutierung
- Novartis Investigative Site
-
Montreal, Quebec, Kanada, H4A 3T2
- Rekrutierung
- Novartis Investigative Site
-
Montreal, Quebec, Kanada, H1Y 3L1
- Rekrutierung
- Novartis Investigative Site
-
Québec, Quebec, Kanada, G1W 4R4
- Rekrutierung
- Novartis Investigative Site
-
Québec, Quebec, Kanada, G1V 4X7
- Rekrutierung
- Novartis Investigative Site
-
Ste-Foy, Quebec, Kanada, G1V 4G2
- Rekrutierung
- Novartis Investigative Site
-
Verdun, Quebec, Kanada, H4G 3E7
- Rekrutierung
- Novartis Investigative Site
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Kanada, S7K 2C1
- Rekrutierung
- Novartis Investigative Site
-
Saskatoon, Saskatchewan, Kanada, S7K 0H6
- Rekrutierung
- Novartis Investigative Site
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Screening
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: 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:
|
PEST Screening group |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Positive Predictive Value (PPV) for PEST and PEST+2 in adult patients with moderate-to-severe plaque PsO who are candidates for bDMARDs
Zeitfenster: Up to approximately 1 year
|
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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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
Zeitfenster: Up to approximately 1 year
|
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
|
|
Proportion of patients with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist
Zeitfenster: Up to approximately 1 year
|
Proportion of patients with a new PsA diagnosis or suspicion of PsA, confirmed by the rheumatologist who scored:
|
Up to approximately 1 year
|
|
Proportion of patients with a false positive score between each group
Zeitfenster: Up to approximately 1 year
|
Proportion of patients with false positive score between each group will be evaluated:
|
Up to approximately 1 year
|
|
Description of the baseline characteristics of the positive screening score and negative screening score patients for both PEST and PEST+2 tests
Zeitfenster: Up to approximately 1 year
|
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
|
|
Patient acceptability/user experience of the PEST+2 questionnaire
Zeitfenster: Up to approximately 1 year
|
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
|
|
Administration of dermatologist quantitative surveys
Zeitfenster: Up to approximately 1 year
|
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
|
|
Qualitative interview with selected dermatologists
Zeitfenster: Up to approximately 1 year
|
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
|
|
Intervention Appropriateness Measure (IAM)
Zeitfenster: Up to approximately 1 year
|
To assess the appropriateness of the PEST+2 from the perspective of rheumatologists |
Up to approximately 1 year
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CAIN457ACA06
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .