NL-OMON41245已完成4 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 - M13-375 Spondyloarthritis study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AbbVie B.V.
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Main Inclusion: ;- Adult subjects with inadequate response of 2 or more 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;- Negative TB screening assessment;- Ability to administer subcutaneous injections;- General good health otherwise
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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