NCT00133315已完成4 期
TNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With Spondylarthropathies
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 18
研究概览
简要总结
The purpose of the study is to establish a Danish cohort of spondylarthropathy (SpA) patients who are being treated with TNFalfa blockers. By following the TNFalfa blocking treated patients the researchers want to identify better biomarkers for disease activity and disease progression. In addition, the researchers want to identify predictors for disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age>18 years old
- •Spondylarthropathies according to the European Spondylarthropathy Study Group (ESSG) criteria
- •Sacroiliitis by X-ray or magnetic resonance imaging (MRI)
- •Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)>3
- •No signs of tuberculosis (TB)
- •Sufficient contraception
排除标准
- •Wish of pregnancy or nursing
- •Previous treatment with TNFalfa blocker
- •Disease-modifying anti-rheumatic drugs (DMARDs) other than methotrexate (MTX) later than 4 weeks before inclusion
- •Steroid treatment later than 4 weeks before inclusion
- •Immunosuppressing agents later than 4 weeks before inclusion
- •Severe infections within 3 months
- •HIV-infection
- •Active hepatitis B and C
- •Active or latent TB
- •Severe chronic diseases
- •Heart insufficiency (New York Heart Association [NYHA] 3 and 4)
- •Malignancy
- •Systemic lupus erythematosus (SLE) or SLE-like disease
- •Abuse of narcotics or alcohol
- •Major psychiatric disorders
研究者
研究点 (18)
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