Doppler Quantitative Evaluation and Follow-up Over 12 Months in RA Patients With Moderate and High Disease Activity Who Are Candidates for Biologic add-on Therapy With Adalimumab
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- The proportion of different clinical (EULAR) response
研究概览
简要总结
The purpose is to study the relationship between RA disease activity based on Doppler quantification and the subsequent clinical response (EULAR response) to treatment with Adalimumab during 12 months. The purpose is also to compare the Doppler quantification with conventional clinical methods and semiquantitative Doppler assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Adult patient (> 18 years of age), male or female
- •Rheumatoid arthritis according to the 1987 ACR or 2010 EULAR/ACR classification criteria
- •Moderate to high disease activity
- •Ongoing anti-rheumatic treatment with DMARD, with stable dosage during the last 3 months, and being a candidate for anti-TNF add-on therapy OR ongoing treatment with first anti-TNF therapy and being a candidate for switch to another anti-TNF therapy
- •Women with child-bearing potential: use of an adequate method of contraception to avoid pregnancy throughout the study
- •Signed Informed Consent *Signed Informed Consent must be obtained before any study specific procedures take place.
排除标准
- •Biologic treatment with Adalimumab before inclusion
- •Two or more ongoing biologic treatments before inclusion
- •Treatment with other biologic treatment than anti-TNF therapy before inclusion
- •Any contraindication for treatment with Adalimumab
- •Intraarticular corticosteroid injection during the last 4 weeks before each follow-up visit
- •Positive for tuberculosis or hepatitis B.
- •Ongoing pregnancy or lactation
研究组 & 干预措施
Arm 1
Adalimumab
干预措施: Adalimumab (Biological)
结局指标
主要结局
The proportion of different clinical (EULAR) response
时间窗: 6 months from BL
The primary endpoint will be the proportion of different clinical (EULAR) response (good, moderate, no response)\* to add-on therapy with anti-TNF treatment at 6 months follow-up visit in patients with activity versus in those without activity measured by Doppler ultrasound at baseline.
次要结局
- The proportion of patients with good response to add-on therapy(6 and 12 months from BL)
研究者
Hamed Rezaei
Chief Arthritis, Inflammation department
Karolinska Institutet