EUCTR2012-000646-35-IT进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Study Comparing the Efficacy and Safety of Continuing Versus Withdrawing Adalimumab Therapy in Maintaining Remission in Subjects with Non Radiographic Axial Spondyloarthritis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 673
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Main Inclusion:
- •- Adult subjects with inadequate response to >/= 2 non-steroidal anti-inflammatories (NSAIDs)
- •- Subject with axial SpA fulfilling the Assessment of Spondyloarthritis International Society (ASAS) axial SpA classification criteria
- •- Subject with evidence of active inflammation in the SI joints or spine on MRI, or elevated hs-CRP
- •- Negative purified protein derivative (PPD) test and Chest X-Ray performed at Baseline Visit must be Negative
- •- Ability to administer subcutaneous injections
- •- General good health otherwise
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 678
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 62
排除标准
- •Main Exclusion:
- •- Prior anti-TNF therapy
- •- Fulfillment of modified New York criteria for Ankylosing Spondylitis
- •- Recent infection requiring treatment
- •- Significant medical events or conditions that may put patients at risk for participation
- •- Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study
- •- History of cancer, except successfully treated skin cancer
- •- Recent history of drug or alcohol abuse
研究者
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