NL-OMON48179已完成不适用
A Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects with Moderate to Severe Rheumatoid Arthritis - M16-560
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
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
- •1. Adult male or female, between 18 and 75 years of age inclusive at Screening.
- •2. Subject has the clinical diagnosis of RA for > 3 months based on the 1987
- •ACR classification criteria or 2010 ACR/European League against Rheumatism
- •(EULAR) criteria.
- •3. Subject meets the following disease activity criteria: >= 4 swollen joints
- •(based on 28 joint count) and >= 4 tender joints (based on 28 joint count) at
- •Screening and BL Visits; and DAS28(CRP) >= 3.2 at Screening.
- •4. Subject has an incomplete response to MTX. Subjects must have been on oral
- •or parenteral MTX therapy >= 3 months and on a stable prescription of 15 to 25
- •mg/week (or >= 10 mg/week in subjects intolerant of MTX at doses >= 15 mg/week)
- •for >= 4 weeks prior to the first dose of study drug. Subject must be expected
- •to be able to continue on stable dose of MTX for the duration of study
- •participation.
排除标准
- •1. Subjects previously exposed to adalimumab or other anti-TNF biologics.
- •2. Subjects previously exposed to non-anti-TNF biologics or targeted synthetic
- •DMARDs for RA, with exception of subjects exposed for less than 3 months and
- •terminated not due to lack of efficacy or intolerability.
研究者
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