NCT05925842Enrolling By Invitation不适用
Clinical and Molecular Characterization of Axial Psoriatic Arthritis (PsA), A Pilot Study
Group for Research and Assessment of Psoriasis and Psoriatic Arthritis2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Target biomarker identification
研究概览
简要总结
Objectives: To identify a candidate set of biomarkers specific to AxPsA. Overview: Clinical and imaging characterization of PsA patients will be combined with extensive molecular assessment of both liquid and tissue compartments to identify biomarkers which differentiate PsA patients with and without axial involvement
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons with PsA diagnosed by a consultant Rheumatologist with disease duration of > 3 months but < 10 years with or without IBP.
- •Adults between the ages 18 and 80 years, with joint disease onset after 16 years of age
- •Patients able to understand and complete consent procedures
- •Study participants must have PsA, meet CASPAR criteria, and must have active disease as defined by the treating rheumatologist, including an evaluable psoriatic skin lesion amenable to 6mm punch skin biopsy.
- •o Psoriasis should be diagnosed by a consultant rheumatologist or dermatologist.
- •Study participants must have been on consistent therapy for their PsA for the past 90 days
- •Study participants must be naïve to biological treatment and targeted synthetic DMARD treatment (examples: JAK inhibitors, apremilast)
排除标准
- •• Persons with musculoskeletal (peripheral or axial) symptoms for >10 years
- •Persons with planned major surgery (e.g., joint replacement) within the duration of the collection of data for the study
- •Persons with a history of chemotherapy, radiation therapy or immunotherapy for cancer in the preceding 5 years.
- •Persons with ongoing cancer (not excluding non-melanoma skin, cervical/breast in-situ carcinoma) but those fully recovered from an episode of cancer (in remission for more than 5 years) may be included at the discretion of the patient's treating rheumatologist.
- •Persons with an active severe or serious infection
- •Patients with non-severe infection at the discretion of the Investigator
- •Persons with other concomitant disorders incompatible with study (at discretion of Investigator).
结局指标
主要结局
Target biomarker identification
时间窗: 18 months
Identify candidate biomarkers able to discriminate between PsA with and without axial involvement
次要结局
未报告次要终点
研究者
研究点 (2)
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