Modifying PEST for Psoriatic Arthritis Screening

Официальное название

A Multicenter, Prospective, Study to Evaluate the Impact of Modifying the Validated Psoriasis Epidemiology Screening Tool (PEST) on the Potential Diagnosis of Psoriatic Arthritis in Adult Patients With Moderate-to-severe Plaque Psoriasis in Canada ("ScreenX")

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест PEST Screening group
  PEST Screening group

Первичные конечные точки

• Positive Predictive Value (PPV) for PEST and PEST+2 in adult patients with moderate-to-severe plaque PsO who are candidates for bDMARDs [Срок оценки: Up to approximately 1 year]

Вторичные конечные точки (8)

• 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 [Срок оценки: Up to approximately 1 year]
• Proportion of patients with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist [Срок оценки: Up to approximately 1 year]
• Proportion of patients with a false positive score between each group [Срок оценки: 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 [Срок оценки: Up to approximately 1 year]
• Patient acceptability/user experience of the PEST+2 questionnaire [Срок оценки: Up to approximately 1 year]
• Administration of dermatologist quantitative surveys [Срок оценки: Up to approximately 1 year]
• Qualitative interview with selected dermatologists [Срок оценки: Up to approximately 1 year]
• Intervention Appropriateness Measure (IAM) [Срок оценки: Up to approximately 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Канада · 30 центров

• Novartis Investigative Site — Calgary
• Novartis Investigative Site — Edmonton
• Novartis Investigative Site — Edmonton
• Novartis Investigative Site — Kelowna
• Novartis Investigative Site — Surrey
• Novartis Investigative Site — Winnipeg
• Novartis Investigative Site — Fredericton
• Novartis Investigative Site — Barrie
• … и ещё 22 центра

Идентификаторы

NCT: NCT06382051 · CAIN457ACA06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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