EUCTR2007-002716-26-LV进行中（未招募）不适用
A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085
CB Celltech0 个研究点目标入组 200 人开始时间: 2007年11月5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
- 200
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 participated in study C87085 in which the subject completed the study at Week 6 OR
- •the subject completed the week 2 assessment and whose Crohn’s disease was significantly worse as determined by the investigator and whose CDAI score at entry into the study is either:
- •· at least 70 points higher than week 0 in C87085 OR
- •· higher than week 0 in C87085 with an absolute CDAI score of at least 350 points
- •Subjects may have received active or placebo treatment in C87085
- •2. Subject is capable of providing informed consent, which must be obtained prior to any study related procedures
- •3. Have a chest X-ray taken at visit 1 that is read by a qualified radiologist or pulmonary physician, with no evidence of current active TB or old inactive TB
- •4. Subject has taken a TB survey and is committed to comply with TB prophylaxis if applicable
- •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
- •1. Subject is experiencing an ongoing serious adverse event assessed as being related to study medication or is experiencing a serious adverse event that is still not assessable
- •2. Subject has an intercurrent illness that requires termination of treatment, such as a serious infection (e.g. TB, pneumonia, sepsis, pyelonephritis, fistula abscess)
- •3. Subject is non-compliant with TB prophylactic treatment (if applicable)
- •4. Subject has had a chest X-ray at visit 1 that shows an abnormality suggestive of a malignancy or active infection, including TB
- •5. Female who is pregnant or breast feeding
- •6. Female of child bearing age not practicing effective birth control
- •7. Subject is expecting to receive any live virus or bacterial vaccination within 3 months of first Study Medication administration, during the trial or 3 months after last dose of study drug
研究者
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