NCT02293564已完成不适用
An Open-label Safety Extension Study of Gevokizumab in Active Inflammatory, Erosive Osteoarthritis of the Hand
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 312
- 主要终点
- Treatment-emergent adverse events
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety of gevokizumab in the treatment of active inflammatory, erosive osteoarthritis of the hand.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Diagnosis of hand osteoarthritis
- •Joint tenderness and/or redness
- •At least one erosion by X-ray (as determined by the central reader)
- •Contraceptive measures adequate to prevent pregnancy during the study
排除标准
- •History of inflammatory disease other than hand erosive osteoarthritis (EOA) including: secondary post-traumatic osteoarthritis (OA); rheumatoid arthritis; spondylarthropathies; erosion of the ulnar styloid process; psoriatic arthritis; skin psoriasis; erosions of the wrist; fibromyalgia
- •History of gout, pseudogout, or hemochromatosis
- •History of allergic or anaphylactic reactions to monoclonal antibodies
- •History of recurrent or chronic systemic infections
- •Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
gevokizumab
Experimental
干预措施: gevokizumab (Drug)
结局指标
主要结局
Treatment-emergent adverse events
时间窗: Up to two years
Safety analyses will involve examination of the incidence, severity, and type of treatment-emergent adverse events reported.
次要结局
未报告次要终点
研究者
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