NCT00141830已完成2 期
A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy
Wyeth is now a wholly owned subsidiary of Pfizer35 个研究点 分布在 6 个国家目标入组 159 人开始时间: 2005年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 35
- 主要终点
- -ACR 20 response at Week 12
研究概览
简要总结
The primary objective of this study is to compare the efficacy and safety of 3 dose levels of oral ERB-041 administered daily for 12 weeks versus placebo in subjects with active rheumatoid arthritis who have had a suboptimal response to therapy with stable doses of methotrexate (MTX).
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
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of active rheumatoid arthritis for at least 6 months and on a stable dose of methotrexate for at least 12 weeks
- •Rheumatoid arthritis onset after 16 years of age
排除标准
- •Any significant health problem other than rheumatoid arthritis
- •History of male or female reproductive system cancer
- •Clinically significant laboratory abnormalities
结局指标
主要结局
-ACR 20 response at Week 12
次要结局
- Secondary efficacy measures include ACR 50 and ACR 70 response.
研究者
研究点 (35)
Loading locations...
相似试验
终止
2 期
Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate TherapyRheumatoid ArthritisNCT00076206Wyeth is now a wholly owned subsidiary of Pfizer
终止
2 期
Maintaining Suppression of Testosterone With Transdermal Estradiol GelCancer of the ProstateNCT02349386BHR Pharma, LLC34
已完成
2 期
A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.Arthroplasty, Replacement, KneeVenous ThrombosisNCT00246025Boehringer Ingelheim512
已完成
2 期
Safety Study of Anti-IgE Immunotherapy in Allergic PatientsAllergyNCT00439621Resistentia Pharmaceuticals AB42
已完成
2 期
A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With EndometriosisEndometriosisNCT02778399ObsEva SA328