NCT01029847已完成4 期
Adalimumab in Axial Spondyloarthritis. An Investigation of Whole-body MRI, MRI of Sacroiliac Joints and Spine and Soluble Biomarkers of Joint Inflammation and Damage.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 8
- 主要终点
- Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50%
研究概览
简要总结
Investigation of wholebody MRI and circulating biomarkers of inflammation, cartilage and bone metabolism in patients with spondyloarthritis treated with adalimumab. Furthermore to compare ultrasound examination with wholebody MRI etc.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spondyloarthritis (SpA) according to the new ASAS criteria for axial SpA
- •BASDAI > 40 mm despite NSAIDs
- •Clinical indication for treatment with TNF-alpha inhibitor
- •Age > 18 years old and < 85 years old
- •Sufficient contraception for women
- •Capable of giving informed consent
- •Capable of complying with the examination program of the protocol
排除标准
- •Pregnancy wish, pregnancy or breast-feeding
- •DMARDs within 4 weeks prior to inclusion
- •Oral, intra-articular or intramuscular glucocorticoid within 4 weeks prior to inclusion
- •The use of other study drugs within 4 weeks prior to inclusion or less than 5 half-lives of the study drug before inclusion if this is more than 4 weeks
- •The use of suspected disease-modifying or immunosuppressive drugs within 4 weeks prior to inclusion
- •DMARDs are allowed during the study, but the dose cannot be changed from 4 weeks prior to inclusion through week
- •Contraindications for TNF-α inhibitor treatment
- •Contraindications for MRI
- •Known recent drug or alcohol abuse
- •Failure to provide written consent
- •Incapable of complying with the examination program for physical or mental reasons
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Adalimumab
Active Comparator
TNF-alpha inhibitor
干预措施: Adalimumab (Drug)
结局指标
主要结局
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50%
时间窗: 24 weeks
次要结局
- Number of peripheral and axial joints and entheses with inflammation, circulating biomarkers of inflammation, cartilage and bone metabolism, conventional clinical parameters and changes in these during treatment with adalimumab.(24 week)
研究者
Professor Mikkel Østergaard
Professor
Rigshospitalet, Denmark
研究点 (8)
Loading locations...
相似试验
尚未招募
4 期
Effects of adalimumab on biomarkers in synovial tissue in patients with rheumatoid arthritis1000381610023213Rheumatoid arthritisNL-OMON30623Academisch Medisch Centrum30
Unknown
4 期
Adalimumab in Alleviating Inflammation in Patients With Axial SpondyloarthritisAnkylosing SpondyloarthritisNCT02634541University of Helsinki60
Unknown
2 期
D2E7-Early ASAnkylosing SpondylitisNCT00235105Charite University, Berlin, Germany46
尚未招募
不适用
Added Value of Diffusion Weighted MRI in Evaluation of Sacroiliitis in Newly Diagnosed Patients of Spondyloarthropathy.Spondyloarthropathy and SacroilitisNCT05655533Assiut University50
已完成
不适用
Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA)Rheumatoid ArthritisNCT00497614University Hospital, Tours8