Multicenter, Prospective, Open-label, Cohort Study With Collection of Blood Samples and Ultrasound / MRI and X-ray Examination
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 主要终点
- Determination of the predictive value of US alone and in combination with cartilage biodegradation markers on radiographic progression (change in Ratingen score)
研究概览
简要总结
Multicenter, prospective, open-label, cohort study. Primary objective: Determination of the predictive value of US alone and in combination with cartilage biodegradation markers on radiographic progression (change in Ratingen score)
Secondary objectives:
- Correlation of ultrasound synovitis score and clinical disease activity score
- Determination of the sensitivity of ultrasound erosion detection compared to MRI
- Assessment of the value of including tenosynovitis assessment for predicting radiographic progression
- Assessment of the predictive value of ultrasound synovitis score at baseline for the need to install biologic DMARDs
详细描述
Multicenter, prospective, open-label, cohort study with collection of blood samples and ultrasound / MRI and x-ray examination.
Duration of study: 12 months This study is a prospective cohort study. The choice of therapy at any time during the study is entirely up to the treating rheumatologist. The study does not put any restriction on the management of the patient which will be according to routine care.
At occurrence of one or more of the above mentioned variables defining adverse clinical outcome (prednisone in a dose exceeding 10mg/d and/or intraarticular steroid injections and/or start of biologic DMARD) an analysis as for D360 will be performed US-Score: SONAR-Score assessment of synovitis (22 joints)/erosions (14 joints)/cartilage thickness (8 joints) Clinical evaluation: Disease activity score (DAS28 = Number of tender and swollen joints (0-28), additional measures (ESR / CRP), Patient Global Health (0-100), health assessment questionnaire (HAQ) at 0, 3, 6, 9, 12 months (attached) Lab: ESR, CRP Serology: Antinuclear antibody (ANA), Rheumatoid factor (RF), Anti-cyclic citrullinated peptide (anti-CCP) at baseline if not available COL2-1 / COL2-1N X-Ray: hands and feet at baseline and 12 months (scoring according to Ratingen Score) if not available MRI without contrast at baseline and at 12 months or when first erosions detected with US
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients fulfilling all of the following inclusion criteria may be enrolled in the study:
- •male and female subjects, Age above 18 yrs
- •recent onset RA fulfilling the American College of Rheumatology (ACR) criteria (revised 2010)
- •Symptoms for at least 6 weeks
- •no previous DMARD treatment
- •no intraarticular steroid injections in the last 4 weeks before inclusion
- •no treatment with oral steroids exceeding the equivalent of 10mg prednisone per day in the last 2 weeks before inclusion
- •signed Informed Consent after being informed
排除标准
- •History of inflammatory joint disease other than RA
- •History of active Tbc, histoplasmosis or listeriosis
- •History of lymphoma or other malignancies within 5 years
- •Contraindication for the use of DMARD's or biologics
- •Comorbidities: severe myocardial dysfunction, recent stroke (within 3 months), uncontrolled diabetes and other disease which in the opinion of the investigator, would put the subject at risk by participation in the trial
- •History of demyelinating disorders
- •persistent or recurrent infections
- •Pregnancy or breast feeding
- •no informed consent
研究组 & 干预措施
cohort study
Collection of blood samples and ultrasound / MRI and x-ray examination.
干预措施: Venipuncture, ultrasound, MRI, x-ray (Procedure)
结局指标
主要结局
Determination of the predictive value of US alone and in combination with cartilage biodegradation markers on radiographic progression (change in Ratingen score)
时间窗: 12 months
次要结局
- Correlation of ultrasound synovitis score and clinical disease activity score(12 months)
- Determination of the sensitivity of ultrasound erosion detection compared to MRI(12 months)
- Assessment of the value of including tenosynovitis assessment for predicting radiographic progression(12 months)
- Assessment of the predictive value of ultrasound synovitis score at baseline for the need to install biologic DMARDs(12 months)