ISRCTN50167738已完成4 期
Quantitative MRI to define mechanisms of cardiovascular co-morbidity in patients with early Rheumatoid Arthritis and to measure the effect of biological therapy: a randomised controlled trial
niversity of Leeds (UK)0 个研究点目标入组 100 人开始时间: 2013年11月8日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
- 2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25381560 2. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/27895040
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males and females
- •2. Aged between 18 and 80 years
- •3. Diagnosed with RA according to 2010 ACR/EULAR criteria
- •4. Who have not yet received therapy with disease modifying drugs
- •5. Have early (symptoms for less than 1 year)
- •6. Active disease (clinical or imaging evidence of synovitis and DAS28- ESR >/= 3.2)
- •7. At least one poor prognostic factor (anti-citrullinated peptide antibody +/- abnormal power Doppler in at least 1 joint)
- •1. Males and females without RA
- •2. Aged between 18 and 80 years
- •3. Matched for age and blood pressure
排除标准
- •1. Previous treatment with DMARDs
- •2. Contraindications to MRI and to anti-TNF therapy and severe co-morbidity that would in the clinician?s opinion be associated with unacceptable risk of receiving potentially anti-TNF therapy
- •3. Contraindications to MRI (incompatible metallic implants, pacemakers)
- •4. Renal failure (eGFR<30 ml/min/1.73m2)
- •5. Previous allergic reactions to MRI contrast agents
- •6. Known cardiovascular disease (CVD)
- •7. Contraindications to adenosine (asthma or high grade heart block)
- •1. History of RA or other inflammatory disease
- •2. Contraindications to MRI
- •3. Contrast agents or adenosine or presence of renal failure as defined above
- •4. Known CVD
研究者
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