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")
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 502
- 试验地点
- 30
- 主要终点
- Positive Predictive Value (PPV) for PEST and PEST+2 in adult patients with moderate-to-severe plaque PsO who are candidates for bDMARDs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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:
- Psoriasis Epidemiology Screening Tool (PEST) consisting of 5 simple questions
- 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
- 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.
干预措施: PEST Screening group (Diagnostic Test)
结局指标
主要结局
Positive Predictive Value (PPV) for PEST and PEST+2 in adult patients with moderate-to-severe plaque PsO who are candidates for bDMARDs
时间窗: 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?
次要结局
- 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(Up to approximately 1 year)
- Intervention Appropriateness Measure (IAM)(Up to approximately 1 year)
- Proportion of patients with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist(Up to approximately 1 year)
- Proportion of patients with a false positive score between each group(Up to approximately 1 year)
- Qualitative interview with selected dermatologists(Up to approximately 1 year)
- Patient acceptability/user experience of the PEST+2 questionnaire(Up to approximately 1 year)
- Administration of dermatologist quantitative surveys(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(Up to approximately 1 year)