Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Ændring af PEST til screening af psoriasisgigt (ScreenX)

25. september 2026 opdateret af: Novartis Pharmaceuticals

Et multicenter, prospektivt studie for at evaluere virkningen af ​​at ændre det validerede psoriasis epidemiologiske screeningsværktøj (PEST) på den potentielle diagnose af psoriasisarthritis hos voksne patienter med moderat til svær plakpsoriasis i 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

502

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Rekruttering
        • Novartis Investigative Site
      • Edmonton, Alberta, Canada, T6G 2C8
        • Rekruttering
        • Novartis Investigative Site
      • Edmonton, Alberta, Canada, T5J 3S9
        • Rekruttering
        • Novartis Investigative Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1W 4V5
        • Rekruttering
        • Novartis Investigative Site
      • Surrey, British Columbia, Canada, V3R 6A7
        • Rekruttering
        • Novartis Investigative Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
        • Rekruttering
        • Novartis Investigative Site
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Rekruttering
        • Novartis Investigative Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 6L2
        • Rekruttering
        • Novartis Investigative Site
      • Greater Sudbury, Ontario, Canada, P3C 1X8
        • Rekruttering
        • Novartis Investigative Site
      • Hamilton, Ontario, Canada, L8N 1V6
        • Rekruttering
        • Novartis Investigative Site
      • Hamilton, Ontario, Canada, L8J 0G5
        • Rekruttering
        • Novartis Investigative Site
      • Hamilton, Ontario, Canada, L8P 4B4
        • Rekruttering
        • Novartis Investigative Site
      • London, Ontario, Canada, N6A 5R9
        • Rekruttering
        • Novartis Investigative Site
      • London, Ontario, Canada, N6G 0W7
        • Rekruttering
        • Novartis Investigative Site
      • Markham, Ontario, Canada, L3R 2C7
        • Rekruttering
        • Novartis Investigative Site
      • Ottawa, Ontario, Canada, K2A 3Z3
        • Rekruttering
        • Novartis Investigative Site
      • Richmond Hill, Ontario, Canada, L4C 9M7
        • Rekruttering
        • Novartis Investigative Site
      • Stoney Creek, Ontario, Canada, L8G 1H1
        • Rekruttering
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M4A 2S8
        • Rekruttering
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5S 1B6
        • Rekruttering
        • Novartis Investigative Site
      • Waterloo, Ontario, Canada, N2J 1C4
        • Rekruttering
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Rekruttering
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H4A 3T2
        • Rekruttering
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H1Y 3L1
        • Rekruttering
        • Novartis Investigative Site
      • Québec, Quebec, Canada, G1W 4R4
        • Rekruttering
        • Novartis Investigative Site
      • Québec, Quebec, Canada, G1V 4X7
        • Rekruttering
        • Novartis Investigative Site
      • Ste-Foy, Quebec, Canada, G1V 4G2
        • Rekruttering
        • Novartis Investigative Site
      • Verdun, Quebec, Canada, H4G 3E7
        • Rekruttering
        • Novartis Investigative Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 2C1
        • Rekruttering
        • Novartis Investigative Site
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Rekruttering
        • Novartis Investigative Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Key inclusion criteria:

  1. Moderate-to-severe plaque PsO patients who are candidates for bDMARDs, according to physician's clinical judgement at the time of patient enrollment.
  2. Adult patients at the time of informed consent signature
  3. Patients able to understand and willing to comply with protocol requirements, instructions, and restrictions
  4. Residents of Canada

Key exclusion criteria:

  1. Patients who have previously screened positive for PsA through PEST.
  2. Patients who have been diagnosed with PsA.
  3. Patients who have been diagnosed with inflammatory arthritis unrelated to PsA (rheumatoid arthritis, reactive arthritis, enteropathic arthritis, axial spondyloarthritis)
  4. 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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:

  1. Psoriasis Epidemiology Screening Tool (PEST) consisting of 5 simple questions
  2. PEST+2 refers to the PEST modified with two additional questions (Do you have morning stiffness that lasts for more than one (1) hour? Do you wake up at night because of low back or buttock pain?), AND
  3. PEST+pictures which provides an opportunity for patients to modify their answers to PEST questions 1, 3, and 5 by presenting them with pictures of swollen joints, fingernail pitting, and swollen fingers and toes.
Diagnostisk test: PEST Screening group

PEST Screening group

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Positive Predictive Value (PPV) for PEST and PEST+2 in adult patients with moderate-to-severe plaque PsO who are candidates for bDMARDs
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: Up to approximately 1 year

Proportion of patients with a new PsA diagnosis or suspicion of PsA, confirmed by the rheumatologist who scored:

  1. Negative on PEST and positive on PEST+pictures
  2. Negative on PEST+2 and positive on PEST+pictures+2 will be evaluated to assess the impact of adding pictures as reference to guide patients answering the screening questions (question 1, 3, and 5)
Up to approximately 1 year
Proportion of patients with a false positive score between each group
Tidsramme: Up to approximately 1 year

Proportion of patients with false positive score between each group will be evaluated:

  1. PEST+2 vs. PEST+pictures+2
  2. PEST+pictures vs. PEST
  3. PEST+pictures+2 vs. PEST
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Up to approximately 1 year

To assess the appropriateness of the PEST+2 from the perspective of rheumatologists
Up to approximately 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Efterforskere

  • Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. januar 2025

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

19. april 2024

Først indsendt, der opfyldte QC-kriterier

19. april 2024

Først opslået (Faktiske)

24. april 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CAIN457ACA06

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner