Modifisering av PEST for screening av psoriasisartritt (ScreenX)
En multisenter, prospektiv studie for å evaluere virkningen av å modifisere det validerte psoriasisepidemiologiske screeningsverktøyet (PEST) på den potensielle diagnosen psoriasisartritt hos voksne pasienter med moderat til alvorlig plakkpsoriasis 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Novartis Pharmaceuticals
- E-post: novartis.email@novartis.com
Studer Kontakt Backup
- Navn: Novartis Pharmaceuticals
- Telefonnummer: +41613241111
- E-post: novartis.email@novartis.com
Studiesteder
-
-
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
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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:
|
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:
|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CAIN457ACA06
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .