Aiming for Remission in Rheumatoid Arthritis: a Randomized Trial Examining the Benefit of Ultrasonography in a Clinical TIght Control Regimen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 11
- 主要终点
- Complete clinical Disease Activity Score (DAS) remission
研究概览
简要总结
The ultimate goal of treatment in early rheumatoid arthritis (RA) is remission, i.e. an absence of signs and symptoms of the disease. However, the optimal way of reaching this goal is not known.
Ultrasonography (US) is an imaging modality which application is rapidly growing. It has a number of advantages over other advanced imaging techniques such as magnetic resonance imaging (MRI), including low cost, good accessibility, and ability to scan many joints in a short period of time. However, the additional benefit of using this modality in terms of patient outcomes has not been demonstrated. Thus, clarification is needed if the use of US leads to better care for RA patients.
This study will assess if the use of a treatment strategy incorporating information from ultrasonography assessment will allow for better outcomes of patients with RA, than a strategy based on clinical and laboratory assessments alone.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant, non-nursing female
- •> 18 years of age and < 75 years of age
- •Patients classified as having RA (according to new ACR/EULAR criteria)
- •Disease duration less than 2 years (defined as time from 1st joint swelling)
- •The treating rheumatologist decides the patient requires treatment with a Disease Modifying Anti-Rheumatic Drug (DMARD)
- •The patient has taken no prior DMARD
- •Patients able and willing to give written informed consent and comply with the requirements of the study protocol
排除标准
- •Abnormal renal function (serum creatinine > 142 µmol/L in female and > 168 µmol/L in male)
- •Abnormal liver function, active or recent hepatitis, cirrhosis
- •Major co-morbidities like severe malignancies, severe diabetic mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease and/or severe respiratory diseases.
- •Leukopenia and/or thrombocytopenia
- •Inadequate birth control conception, pregnancy, and/or breastfeeding
- •Indications of active tuberculosis
- •Psychiatric or mental disorders, alcohol abuse or other abuse of substances, language barriers or other factors which makes adherence to the study protocol impossible
研究组 & 干预措施
Conventional clinical and laboratory assessment
Conventional assessment plus ultrasonography
干预措施: Ultrasonography (Device)
结局指标
主要结局
Complete clinical Disease Activity Score (DAS) remission
时间窗: 24 months
Specifically, the primary endpoint will be the proportion of patients with all the following criteria met at the end of the study (at 24 months): * DAS score \< 1.6 at visits 11, 12 and 13 (after 16, 20 and 24 months) * Absence of swollen joints at visits 11, 12 and 13 (after 16, 20 and 24 months) * No radiological progression between visit 11 (16 months) and visit 13 (24 months)
次要结局
- Magnetic Resonance Imaging (MRI) of dominant hand(12 months)
- The RA Impact of Disease (RAID) score(12 months)
- American College of Rheumatology (ACR) response(12 months)
- Remission(12 months)
- European League Against Rheumatism (EULAR) response(12 months)
- Medical Outcomes Study Short-Form 36-item (SF-36)(12 months)
- Work performance(12 months)
- Conventional radiography(12 months)
- EuroQol-5 Dimension (EQ-5D)(24 months)
- Health Assessment Questionnaire (HAQ-PROMIS)(12 months)
- Dual Energy X-ray Absorptiometry (DEXA) of spine and hip(12 months)
- Disease Activity Score (DAS)(12 months)
- Ultrasonography (synovitis)(12 months)
- Magnetic Resonance Imaging (MRI) of dominant hand(24 months)
- American College of Rheumatology (ACR) response(24 months)
- Remission(24 months)
- European League Against Rheumatism (EULAR) response(24 months)
- Work performance(24 months)
- Conventional radiography(24 months)
- Ultrasonography (synovitis)(24 months)
- The RA Impact of Disease (RAID) score(24 months)
- Health Assessment Questionnaire (HAQ-PROMIS)(24 months)
- Medical Outcomes Study Short-Form 36-item (SF-36)(24 months)
- Dual Energy X-ray Absorptiometry (DEXA) of spine and hip(24 months)
- Disease Activity Score (DAS)(24 months)
研究者
Espen A. Haavardsholm
Post. doctoral Researcher, MD Ph.D.
Diakonhjemmet Hospital