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临床试验/NCT02389283
NCT02389283Unknown不适用

Sensitivity to Change of Different Reduced Ultrasound Counts in Rheumatoid Arthritis

Hospital General Universitario Gregorio Marañon1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Mode B and power Doppler (PD) ultrasound evaluation

研究概览

简要总结

Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by intra and peri-articular synovial inflammation. Synovitis can damage the articular cartilage, bones, joint capsule, tendons and ligaments leading to the consequential functional joint deterioration.

The main goal of RA treatment is to achieve disease remission. The treatment of RA consists of synthetic and biologic disease modifying drugs (DMARDs), being the second ones selected when low disease or remission is not achieved with the first ones. Therapeutic response monitoring in RA should be closely managed. It is classically based on clinical exploration and laboratory tests. During the last decade, the resolution improvement of musculoskeletal ultrasound (MSUS) imaging has led to the gradual incorporation of this technique in the evaluation and monitoring of patients with RA, mainly due to its better capacity to detect synovitis than clinical exploration . Ultrasound imaging is highly available, non-invasive, reproducible, affordable and well accepted by patients. Ultrasound doppler mode detects pathological synovial flow, which reflects synovial inflammation and has a demonstrated sensitivity to change in multiple longitudinal studies. Sonographic evaluation of patients with RA includes the detection of synovitis in B and Doppler mode in the joints accessible by ultrasound. There has been high variability in the literature regarding the number of joints that should be evaluated for an appropriate monitoring of the RA patients. The validity for monitoring the therapeutic response in long standing RA has been demonstrated in three reduced joint counts, including 12, 7 and 6 joints. However, in shorter evolution RA, the sensitivity to change of any of these reduced ultrasound evaluations has never been studied

详细描述

Primary objectives

• To evaluate the sensitivity to change of the Doppler Ultrasound evaluation of 12, 7 and 6 joints counts in RA patients with more than 6 months and less than 5 years of evolution, which initiate an effective treatment for the disease according to indication (biologic DMARD in monotherapy or combined with methotrexate).

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Patients of both genders, ≥ 18 years of age
  • Patients diagnosed with RA (according to the ACR 2010 criteria) with more than 6 months and less than 5 years of active evolution and DAS28 > 3.2 or SDAI > 11, which start treatment with biologic DMARD for the first time, according to the product's summary of products characteristics (SPC).
  • Patients who have granted their written informed consent for the collection and review of their data.

排除标准

  • Patients who are already participating in a clinical trial/s at the moment of participation in this study.
  • Patients with rheumatic disease other than RA

结局指标

主要结局

Mode B and power Doppler (PD) ultrasound evaluation

时间窗: at baseline and 1, 3 and 6 months after the initiation with the biologic DMARD

Mode B and PD ultrasound evaluation will consist in quantifying the synovitis (0 to 3) in B mode (synovial hypertrophy, effusion) and PD with quantification system OMERACT (Outcome Measures in Rheumatology) in the following bilateral joints: * Elbows (anterior and posterior recess) * Carpi (radiocarpal and midcarpal + carpoulnar) (dorsal recess) * Second and third metacarpophalangeal (dorsal recess) * Second and third proximal interphalangeal of hands (dorsal and palmar recesses) * Knees (suprapatellar and parapatelallar recesses) * Tibiotalar (dorsal and lateral recesses) * Second and fifth metatarsophalangeal (dorsal recess)

次要结局

  • Dopler Ultrasound sensitivity to change comparison(at baseline and 1, 3 and 6 months after the initiation with the biologic DMARD)

研究者

发起方
Hospital General Universitario Gregorio Marañon
申办方类型
Other
责任方
Sponsor

研究点 (1)

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