EUCTR2004-002163-24-DE进行中（未招募）不适用
A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 960
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
- •A patient will be eligible for study participation if he/she meets the following criteria:
- •Patients must have successfully enrolled and completed the M02 - 404 or M04-691 study.
- •Female patients: Must continue to utilize a highly effective method of birth control throughout the study and for 70 days after study completion
- •must not be of childbearing potential, defined as postmenopausal at least two years, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
- •Patients must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
- •Adequate cardiac, renal and hepatic function as determined by principal investigator and demonstrated by screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •There were no exclusion criteria for this study since patients participated in the M02-404 and M04-691 studies and were screened against the exclusion criteria of that study.
研究者
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