Biomarkers of Remission in Rheumatoid Arthritis (BioRRA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Time-to-flare of arthritis activity following DMARD cessation
研究概览
简要总结
Rheumatoid arthritis is a common condition affecting approximately 1% of the United Kingdom population; it is an autoimmune disease where the body's natural defences (the immune system) attack the body itself resulting, most notably, in joint damage and arthritis. To help prevent this, patients with rheumatoid arthritis need to take disease-modifying anti-rheumatic drugs (DMARDs). As rheumatoid arthritis is a life-long condition, these drug treatments are prescribed as long-term medications taken for many years.
With successful drug treatment, many patients are able to achieve an excellent control of their disease and their arthritis can go in to remission. At present, there are no markers which can reliably predict which of these patients can reduce their drug treatment, and hence benefit from a lower risk of side effects and inconvenience, without an increase in their arthritis activity.
We invite patients with stable rheumatoid arthritis to participate in this study conducted by Newcastle upon Tyne Hospitals NHS Foundation Trust in collaboration with Newcastle University and funded by the Wellcome Trust. Patients whose arthritis is confirmed as being in remission will be able to stop their DMARD medication and be monitored for a period of 6 months. Patients whose arthritis activity increases during this time will be able to restart their DMARD medication, whereas those patients whose arthritis remains in remission will be able to stay off DMARD medication.
The main aim of this study is to identify clinical, ultrasound and blood markers that can predict which patients will remain in remission after stopping DMARD medication. If identified, these markers could be a useful guide to doctors and patients in the future when deciding whether to stop DMARD therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •Clinical diagnosis of rheumatoid arthritis made by consultant rheumatologist at least 12 months previously
- •Current single or combination use of methotrexate, sulphasalazine and/or hydroxychloroquine
- •Arthritis currently in remission, as judged clinically by referring healthcare professional
- •Willing to consider DMARD withdrawal
排除标准
- •Use of biologic therapy within the past 6 months
- •Received steroids within past 3 months (enteral, parenteral or intra-articular)
- •Use of any DMARD other than methotrexate, sulphasalazine or hydroxychloroquine within the past 6 months (or past 12 months for leflunomide)
- •Current pregnancy, or pregnancy planned within next 6 months
- •Current participation within another clinical trial
- •Inability to provide informed consent
研究组 & 干预措施
DMARD cessation
All patients recruited to the study who have a Disease Activity in 28 Joints C-Reactive Protein (DAS28-CRP) score of < 2.4 and who do not have power Doppler synovitis on a 7-joint musculoskeletal ultrasound scan will stop their DMARD therapy. These patients will then be followed-up for a period of 6 months or until flare of their arthritis activity, whichever is sooner.
干预措施: DMARD cessation (Drug)
结局指标
主要结局
Time-to-flare of arthritis activity following DMARD cessation
时间窗: From recruitment, assessed up to 6 months
Flare of arthritis activity defined as Disease Activity Score in 28 Joints C-Reactive Protein (DAS28-CRP) score greater than or equal to 2.4
次要结局
- Physical disability(At baseline and at 6 months following DMARD cessation)
- Genetic biomarkers of DMARD-free remission(At recruitment)
- Clinical biomarkers predictive of DMARD-free remission(At recruitment)
- Cytokine biomarkers of DMARD-free remission(At recruitment)
- Ultrasound biomarkers of DMARD-free remission(At recruitment)
- Rheumatoid arthritis disease activity(At recruitment and at 1 month, 3 months and 6 months following DMARD cessation)