NCT00650156已完成1 期
A Randomized, Parallel-group, Open-Label, Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis.
AbbVie1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2007年6月最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- pharmacokinetic profile of a single subcutaneous dose of 40 and 80 mg adalimumab
研究概览
简要总结
Pharmacokinetic and Safety Study with Adalimumab in Chinese Subjects with Mild Rheumatoid Arthritis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Male or Female ages 18 years and older.
- •Body weight less than 100 kg.
排除标准
- •Wheelchair-bound or bedridden.
- •Joint surgery involving joints to be assessed within this study, within two months prior to the Screening visit.
- •Intra-articular, intramuscular or intravenous (IV) administration of corticosteroids within 28 days prior to the Screening visit.
- •Prior treatment with any TNF antagonist, including adalimumab.
- •Positive tuberculin PPD
- •Female subjects who are pregnant or breast-feeding.
- •History of HIV or of being immuno-compromised.
- •History of malignancy.
- •Poorly controlled medical condition.
研究组 & 干预措施
40 mg adalimumab
Experimental
干预措施: adalimumab (Biological)
80 mg Adalimumab
Experimental
干预措施: adalimumab (Biological)
结局指标
主要结局
pharmacokinetic profile of a single subcutaneous dose of 40 and 80 mg adalimumab
时间窗: Days 1, 2, 4, 6, 8, 11, 15, 22, & 29
次要结局
- Swollen and Tender Joint counts(Days 1, 15 and 29)
- VAS assessments(Days 1, 15 and 29)
- Adverse event profile(follow up to day 70 after dose)
研究者
研究点 (1)
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