EUCTR2011-003953-25-DE进行中（未招募）不适用
A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject must be a current, on-label user of Humira who rates his/her average Humira injection site related pain (in the last month) as at least 3 cm on a pain Visual Analogue Scale and has had at least 6 consecutive doses of Humira prior to Screening, or a biologic-naïve subject who requires initiation of on-label treatment with Humira.
- •2. Male and Female subjects over 18 who require adalimumab for RA
- •3. Subject has diagnosis of RA as defined by the 1987 revised ACR classifcation criteria.
- •4. Female subjects are either not of childbearing potential or are using birth control.
- •5. Female subjects are not pregnant.
- •6. Subject has negative TB screening test.
- •7. Subjects are judged to be in good health.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Subject has been treated with an investigational product within the last 30 days or 5 half-lives which ever is longer.
- •2. Any infection requiring treatment with IV anti-infectives with 30 days.
- •3. Prior exposure to natalizumab or efalizumab.
- •4. History of invasive infection or demyelinatiing disease.
- •5. Subjects with an active viral infection.
- •6. Subjects with a positive Hepatitis B, HBV-DNR PCR qualitative test for HBc Ab/HBs screen.
- •7. Have received a live vaccine within 3 months prior to study drug administration.
研究者
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