NCT02476084已完成不适用
Biomarker Signature and Musculoskeletal Ultrasound Profile in Rheumatoid Arthritis Patients: a Pilot Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Changes in synovial thickness and vascularity using a limited joint set musculoskeletal ultrasound examination in Rheumatoid Arthritis.
研究概览
简要总结
The purpose of this study is to determine the kinetics of change in quantitative measures of joint inflammation by state of the art power Doppler vascular imaging and to identify biomarkers in biological samples (synovial biopsies, DNA, RNA, PBMC, serum, plasma, urine and stool samples) from parallel cohorts of RA patients undergoing different treatments. This will be achieved implementing MSUS assessments, standard laboratories techniques (such as ELISAs, gene profiling, transcriptome analysis etc.) and the novel CyTOF™ technology.
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
- 否
入选标准
- •Written confirmed diagnosis of Rheumatoid Arthritis as per ACR/EULAR 2010 criteria.
- •If patient is on oral corticosteroids, dose must be stable for 6 weeks prior to baseline visit.
- •Willingness and ability to comply with all the study procedures.
排除标准
- •Any systemic inflammation conditions (other than RA), connective tissue disease or chronic pain disorders that may interfere with the interpretation of the outcome data. Examples include psoriatic arthritis, reactive arthritis, gout, systemic lupus erythematosus (SLE), polymyalgia rheumatic and/or temporal arteritis, Lyme's disease, fibromyalgia and chronic fatigue syndromes.
- •Major surgery planned within 8 weeks prior to screening or planned surgery throughout the study period.
- •Treatment with any investigational agent ≤ 4 weeks prior to baseline (or 5 ≤ half-lives of the investigational drug, whichever is the longer).
- •Intramuscular/intra-articular glucocorticoids for 6 weeks prior to baseline visit.
- •Active infection.
- •Septic arthritis within a native joint within the last 12 months.
- •Sepsis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ.
- •Known HIV or hepatitis B/C infection.
- •Latent TB infection unless they have completed adequate antibiotic prophylaxis.
- •Malignancy (other than basal cell carcinoma) within the last 10 years.
- •New York Heart Association (NYHA) grade 3 or 4 congestive cardiac failure.
- •Demyelinating disease.
- •Presence of a transplanted organ (with the exception of a corneal transplant > 3 months prior to screening).
- •Known recent substance abuse (drug or alcohol).
结局指标
主要结局
Changes in synovial thickness and vascularity using a limited joint set musculoskeletal ultrasound examination in Rheumatoid Arthritis.
时间窗: 3 years
次要结局
- Changes in the distribution of cell populations in biological samples from Rheumatoid Arthritis patients using CyTOF.(3 years)
- Changes in gene expression in biological samples from Rheumatoid Arthritis patients using gene profiling.(3 years)
- Changes in cytokines' concentration in biological samples from Rheumatoid Arthritis patients using ELISA and transcriptome analysis.(3 years)
研究者
研究点 (1)
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