Early Biomarkers for ARthritic PAIN to Guide Improved Treatments for Arthritis (ARPAIN) Study
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from Baseline Numerical Rating Scale (NRS) for pain in target knee after 3 months
研究概览
简要总结
Osteoarthritis (OA) is a condition affecting the whole joint and is a major cause of pain and disability worldwide. Although OA is very common, the initial steps which lead to the development of pain and tissue damage are not fully understood. In this study participants will be investigated for markers in the blood, joint and urine in people who have a diagnosis of osteoarthritis or inflammatory arthritis and are receiving a steroid injection for their condition. Markers will be evaluated in participants with osteoarthritis compared with other types of arthritis, including rheumatoid arthritis and spondyloarthritis.
详细描述
Osteoarthritis (OA) is the most common form of arthritis worldwide. OA causes major disability and pain and places a huge financial burden on healthcare worldwide. In recent work, the gene expression profile of bone marrow lesions (BML) in osteoarthritis has been evaluated. BML in OA have a novel gene expression profile which includes genes involved in inflammation, neurogenesis and matrix turnover. The plan is to investigate the functional significance of the genes found at the protein biomarker level in studies of joint tissue, blood and urine from participants with knee OA and compare these changes with participants who have other forms of arthritis, including rheumatoid arthritis and spondyloarthritis.
A study amendment was added in April 2020 due to Covid-19. We are studying up to 150 additional participants with or without inflammatory conditions who are being treated with immunomodulatory drugs compared with participants who are not on immunomodulators. We will be evaluating the course of Covid-19 infection in people without autoimmune inflammatory conditions, compared with people who have autoimmune inflammatory diseases who are on immunomodulators.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Inclusion Criteria for OA patients:
- •Fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of knee osteoarthritis
- •Symptomatic knee pain
- •On usual care for knee osteoarthritis including paracetamol and/or NSAIDs
- •Inclusion criteria for Inflammatory Arthritis Patients:
- •Fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of inflammatory arthritis i.e. rheumatoid arthritis (Anti-CCP antibodies & Rheumatoid Factor checked ), psoriatic arthritis or spondyloarthropathy
- •Symptomatic knee pain
- •On usual care for arthritis including disease-modifying anti-rheumatic drugs (DMARDs), paracetamol and/or NSAIDs
排除标准
- •Other rheumatological diagnosis e.g. systemic lupus erythematosus, fibromyalgia, Polymyalgia Rheumatica, Gout, Giant Cell Arteritis, Sjogren's syndrome
- •History of uncontrolled depression
- •Recent surgery
- •Uncontrolled ischaemic heart disease
- •Uncontrolled diabetes mellitus
- •Alcohol consumption > 14 units/week as per UK National guidelines
- •Participants unable to give full informed consent
结局指标
主要结局
Change from Baseline Numerical Rating Scale (NRS) for pain in target knee after 3 months
时间窗: Baseline (Visit 1) and 3 months after treatment (Visit 2)
Pain outcome measure. The Numerical Rating Scale for pain has a range of 0 - 10, with the lowest score being 0 and the highest rating at 10.The pain rating will be reported by the participants for their symptomatic knee
次要结局
- Change in Biomarkers 3 months following treatment(Baseline (Visit 1) and 3 months after treatment (Visit 2))