PRECISion medicinE Across the Disease Continuum to Prevent and Treat Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- • Synovial biopsy substudy - Changes in immunological markers of inflammation in synovial tissue
研究概览
简要总结
The study will recruit patients referred to the Rheumatology Out-patient departments. Patients will be recruited to the study or control groups (healthy or disease controls who will be age and sex-matched) as needed. The study will first open to recruitment at Manchester University Hospitals NHS Foundation Trust and then open at other NHS Trusts. Patients will be asked to participate in longitudinal (clinical/imaging/biosample) data and/or sample collection that will improve our understanding of underlying disease mechanisms and identify improved diagnostic, prognostic and predictive biomarkers to understand progression of disease and drug response or resistance.
详细描述
Main Study
Consent to this ethics' main programme will permit collection of routinely collected data and use for research activities. Patients may be recruited at any point along their disease continuum (e.g. time of initial diagnosis, before/after a new treatment intervention, at time of disease flare or stable state).
Patients with established disease who are recruited to the study during their follow up appointments will have pre-existing results and clinical documentation. These retrospective data may also be collected where possible using information documented in case-notes and/or hospital information systems.
Some study-specific information will also be collected.
In addition to the main study, participants will be offered the opportunity to consent to participate in one or more sub-studies which include the additional research procedures (entitled 'basic biological' and 'synovial biopsy'). It will be possible for patients to participate in more than one sub-study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
• Synovial biopsy substudy - Changes in immunological markers of inflammation in synovial tissue
时间窗: Baseline +/- week 12 or 24 after change in therapy
• Synovial biopsy substudy - Changes in immunological markers of inflammation in synovial tissue
• Main study - Change in Disease Activity Score in 28 Joints (DAS28)
时间窗: through to study completion, an average of 2 years
• The Disease Activity Score (DAS) assessment is a derived measurement with differential weight given to each component. The DAS28 is calculated at every visit. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment (0-100). The components of the DAS28 CRP score assessment are: Tender/Painful Joint Count (28); Swollen Joint Count (28), CRP, and the Subject General Health VAS assessment (0-100). The DAS score ranges from 0-10 and higher scores indicate high disease activity. A DAS28 value of \>5.1 indicates high disease activity, 3.2 \<DAS28 ≤5.1 and DAS28 ≤3.2 are defined as moderate and low disease activity. Patients may be considered to be in remission phase if DAS28 is \<2.6
• Biosample substudy - Change in serum biomarkers, gene expression and the distribution of cell populations in biological samples (peripheral blood, synovial fluid, urine) using ELISA, sequencing, flow cytometry and CyTOF
时间窗: through to study completion, an average of 2 years
• Biosample substudy - Change in serum biomarkers, gene expression and the distribution of cell populations in biological samples (peripheral blood, synovial fluid, urine) using ELISA, sequencing, flow cytometry and CyTOF
次要结局
- • Change in Patient reported outcome measure - Functional Assessment of Chronic Illness Therapy - fatigue (FACIT-fatigue)(through to study completion, an average of 2 years)
- • Change in Patient reported outcome measure - Rheumatoid Arthritis Quality of Life (RAQoL)(through to study completion, an average of 2 years)
- • Change in Patient reported outcome measure - EuroQoL (EQ-5D)(through to study completion, an average of 2 years)
- • Change in Patient-completed visual analogue scales - pain (VAS-pain)(through to study completion, an average of 2 years)
- • Change in Patient-completed visual analogue scales - disease activity (VAS-DA)(through to study completion, an average of 2 years)
- • Change in Patient-completed visual analogue scales - fatigue (VAS-fatigue)(through to study completion, an average of 2 years)
- • Change in Patient reported outcome measure - Hospital Anxiety and Depression Scale (HADs)(through to study completion, an average of 2 years)
- • Change in Patient-completed visual analogue scales - general health (VAS-GH)(through to study completion, an average of 2 years)
- • Change in joint damage as measured by conventional radiography of hands and feet(through to study completion, an average of 2 years)
- • Change in Patient reported outcome measure - Health Assessment Questionnaire (HAQ)(through to study completion, an average of 2 years)
- • Change in Physician-completed visual analogue scale of disease activity(through to study completion, an average of 2 years)
- • Change from baseline in Ultrasound (US) synovitis as measured by Power Doppler Ultrasound (PDUS)(through to study completion, an average of 2 years)
研究者
Prof. Maya H. Buch
Clinical Professor of Rheumatology
University of Manchester