Can New Imaging- and Bio-markers Improve the Assessment of Disease Activity and Progression and Predict Therapeutic Outcome in Spondyloarthritis Patients Receiving Adalimumab
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 52
- 试验地点
- 13
- 主要终点
- Reduction in BASDAI of 20 mm or 50%
研究概览
简要总结
Spondyloarthropathies (SpA) are often diagnosed with a considerable delay (often 8-10 years from symptom onset), because the available clinical, biochemical and radiological methods are not sufficiently sensitive. TNF-a antagonists have recently been introduced for treatment of SpA, and current data indicate a higher efficacy than previously available therapies. The improved treatment options have increased the need for improved methods for diagnosis, monitoring and prognostication of these diseases, so that the efficient therapies can be initiated at the optimal time point and monitored optimally. Magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not yet sufficiently studied, methods for this.
详细描述
See brief summary
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of spondyloarthritis according to the European Spondyloarthritis Study Group (ESSG) criteria
- •Clinical active disease, defined as a BASDAI score > 4 despite concurrent NSAID therapy
- •Presence of sacroiliitis on conventional radiography or MRI.
- •Among other issues: Age >18 years; adequate birth control; no contraindications for anti-TNFa-therapy, no previous TNFa-antagonists
排除标准
- •Previous TNFα inhibitor therapy
- •Treatment with disease modifying anti-rheumatic drugs within 4 weeks before screening
- •Oral, intraarticular, intramuscular or intravenous glucocorticoid within 4 weeks before screening
- •Pregnancy or lactation
- •HIV, hepatitis B or C, tuberculosis, other infections
- •Malignancies
- •Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological ore cerebral disease (including demyelinating disease)
- •Contraindications to anti-TNFa-therapy
- •Contraindications to MRI
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Adalimumab
干预措施: Adalimumab (Drug)
结局指标
主要结局
Reduction in BASDAI of 20 mm or 50%
时间窗: 12-24 weeks of treatment
次要结局
未报告次要终点
研究者
MOstergaard
Professor
Glostrup University Hospital, Copenhagen