Targeting Synovitis in Early Rheumatoid Arthritis (TaSER). Intensive Management of Early Rheumatoid Arthritis Using Either Clinical or Musculoskeletal Ultrasound Assessment of Synovitis - a Randomised Study With Blinded Outcome Assessments
试验速览
- 阶段
- 4 期
- 入组人数
- 110
- 试验地点
- 6
- 主要终点
- MRI RAMRIS Erosion Score
研究概览
简要总结
Patients with rheumatoid arthritis are at risk of developing permanent joint damage and disability. This study hopes to identify the most effective way of using existing arthritis medication to minimise the chances of developing permanent disability. Patients will have their arthritis activity assessed using an ultrasound machine. If there is still evidence of active arthritis the participant's arthritis medication will be increased until the arthritis is in remission. The effectiveness of this approach will be compared to the traditional method of assessing arthritis using clinical examination.
Furthermore, it is extremely important to identify those patients most at risk of aggressive disease. The investigators hope to produce a more accurate measurement of disease prognosis by examining the relationship between a series of blood tests and how well controlled rheumatoid arthritis appears after 18 months of therapy. Some patients will also be asked to donate samples of joint fluid and joint lining for additional analysis.
详细描述
PURPOSE 1 - to determine whether it is possible to achieve better control of inflammatory joint disease activity in early rheumatoid arthritis by using musculoskeletal ultrasound, instead of clinical examination, to identify the presence, or absence, of synovitis
NULL HYPOTHESIS 1 - using musculoskeletal ultrasound to confirm / refute the presence of ongoing synovitis will NOT allow better control of early rheumatoid arthritis nor prevent progression of destructive joint disease despite patients receiving more intensive disease modifying therapy regimens
PURPOSE 2 - to determine whether baseline measures of certain biochemical and pathological factors, associated with the development of inflammatory synovitis, are predictive of response to therapy in early rheumatoid arthritis and short term outcome measures of inflammatory joint disease activity, functional ability and quality of life
NULL HYPOTHESIS 2 - serial measures of biochemical and pathological factors, associated with the development of inflammatory synovitis, will NOT correlate with short term outcome measures of disease activity and therefore cannot be used to predict a patient's prognosis nor identify those at risk of progressive, destructive joint disease
TRIAL DESIGN - randomised, prospective single blinded trial of treatment strategy with a nested study correlating baseline measures and 18 month outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Patients attending Early RA clinics with newly diagnosed RA or anti-CCP +ve Undifferentiated Arthritis (UA)
- •Active disease (DAS28 > 3.2)
- •DMARD naïve or DMARD monotherapy for less than 6 weeks
- •Aged 18 or more
排除标准
- •Significant liver disease and/or abnormality of liver function tests
- •AST / ALT > x2 normal, Alkaline Phosphatase > x2.5 normal
- •Renal impairment - serum creatinine > 200 μmol/l, eGFR < 30
- •Cytopenias - white cell count < 4.0, haemoglobin < 10, platelet < 150
- •Pregnancy or planned pregnancy
- •Contraindication to MRI
- •Other co-morbid condition that in the opinion of the investigator would preclude the use of sequential or combination DMARD therapy
结局指标
主要结局
MRI RAMRIS Erosion Score
时间窗: Baseline and 18 months
44 Joint Disease Activity Score
时间窗: Baseline, 3, 6, 9, 12, 15 and 18 months
次要结局
- Plain Xray - Hands and Feet - modified Sharp score(Baseline and 18 months)
- Health Assessment Questionnaire(Baseline, 3, 6, 9, 12, 15 and 18 months)
- Euro-Qol 5D(Baseline, 3, 6, 9, 12, 15 and 18 months)
- EULAR response and remission rates(Baseline and 18 months)
- Biomarker analysis - correlation between baseline values and 18 month radiological outcomes(Baseline)
- Adverse event rates(Throughout period of study)