NCT00647920已完成3 期
Study of the Human Anti-TNF-Antibody Adalimumab
Abbott1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2003年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- ACR20
研究概览
简要总结
A Randomized, Double-Blind, Placebo-Controlled, Study of the Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated with Methotrexate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits 6 swollen joints and 9 tender joints.
排除标准
- •A history of, or current, acute inflammatory joint disease of different origin than RA (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus or any arthritide with onset prior to age 16 years).
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: placebo (Biological)
40 mg
Experimental
干预措施: adalimumab (Biological)
结局指标
主要结局
ACR20
时间窗: Week 12
次要结局
- ACR50(Week 12)
- ACR70(Week 12)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related ArthritisEnthesitis Related Arthritis (ERA)NCT01166282AbbVie (prior sponsor, Abbott)46
已完成
2 期
A Study of Adalimumab to Treat Sarcoidosis of the SkinSarcoidosisNCT00274352Pariser, Robert J., M.D.16
已完成
1 期
Comparative Safety, Tolerability, Pharmacokinetic Study of AVT02 (100MG/ML) and Humira (100MG/ML) in Healthy VolunteersHealthy VolunteersNCT03579823Alvotech Swiss AG24
已完成
2 期
Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic ArthritisArthritisPsoriaticNCT00646386Abbott315
已完成
2 期
A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's DiseaseCrohn's DiseaseNCT00055523Abbott300