NL-OMON30310尚未招募2 期
A randomized, double-blind, placebo-controlled, phase 2a study of the efficacy, safety, and pharmacokinetics of MLN3897 in patients with rheumatoid arthritis taking methotrexate. - C08005
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 6
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
- •Patients should:
- •- Meet the ACR diagnostic criteria for RA
- •- Have a RA Global Functional Class of I, II, or III
- •- Be taking MTX for a minimum of 6 months before screening
- •- If taking oral corticosteroids, no more than 10mg/day and dose unchanged for at least 4 weeks prior to screening
- •- If taking NSAIDs, stable regimen that has been unchanged for at least 2 weeks prior to screening
- •- Have at lease 6 swollen joints and 6 tender joints + at least 2 of the following: Morning stiffness with a duration of at least 45 minutes, CRP > 1.5ml.dL or ESR at least 28mm/h
排除标准
- •Patients cannot:
- •- Be taking any DMARD other than MTX concomitantly or within 1 month prior to study enrollment.
- •- Currently being treated with TNF-antagonists. A wash out of 8 weeks is permitted.
- •- suffer from tuberculosis
- •- have a HIV, Hepatitis B or C infection
- •- Have evidence of an infectious or acute cardiopulonary process on chest X-ray completed at screening
- •- suffer from any other serious illness.
研究者
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