NCT01848561进行中（未招募）不适用
A Long-Term Non-Interventional Postmarketing Study to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
AbbVie512 个研究点 分布在 1 个国家目标入组 8,250 人开始时间: 2013年4月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 8,250
- 试验地点
- 512
- 主要终点
- Evaluation of long term safety of Adalimumab in patients with moderately to severely active UC
研究概览
简要总结
This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For enrollment into the HUMIRA treatment group; adult patients with moderately to severely active UC who has been prescribed HUMIRA therapy according to routine clinical practice and meets one of the following:
- •Is currently taking HUMIRA therapy and has received at least 8 weeks of therapy; OR
- •Is entering after participation in an Abbott or AbbVie sponsored UC study and; has received continuous HUMIRA therapy since initiation of therapy
- •For enrollment into the IMM treatment group; adult patients with moderately to severely active UC who has been prescribed IMM therapy, is currently taking IMM therapy, and has received at least 12 consecutive weeks of IMM therapy
- •Patients capable of and willing to grant authorization for use/disclosure of data being collected and provided to AbbVie prior to any registry-related data being collected, and to comply with the requirements of the Registry protocol
排除标准
- •Patients on IMM therapy without a concurrent biologic if they cannot continue to be treated with IMM therapy or
- •Patients who are being treated with any investigational agents and/or approved biologics other than Humira.
结局指标
主要结局
Evaluation of long term safety of Adalimumab in patients with moderately to severely active UC
时间窗: 10 years observational period
次要结局
- Evaluation of long term effectiveness of Adalimumab in patients with moderately to severely active UC who have had an inadequate response to conventional therapy(10 years observational period)
研究者
研究点 (512)
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