NCT00333788已完成3 期
Open Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 233
- 试验地点
- 64
- 主要终点
- Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)
研究概览
简要总结
The study will continue to assess the safety of certolizumab pegol (CDP870) as well as examine the evolution of long term efficacy in Crohn's disease patients who completed study C87042 [NCT00308581]. It will also assess the effect of subcutaneous CDP870 400 mg on direct cost parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having completed study C87042 [NCT00308581] (previously treated with infliximab)
排除标准
- •Subject withdraw from C87042 [NCT00308581] study
- •Subject who received treatment other than certolizumab pegol and other than medications permitted in C87042 [NCT00308581] study
- •Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment
- •Female patients of childbearing age who are NOT practicing (in the Investigator's opinion) effective birth control. All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every certolizumab pegol administration
研究组 & 干预措施
Certolizumab pegol 400 mg
Experimental
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
干预措施: Certolizumab pegol (CDP870) (Biological)
结局指标
主要结局
Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)
时间窗: Maximum 164 weeks
Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.
次要结局
- Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042).(Baseline (corresponding to Week 26 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals])
- Change From Baseline of Study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals](Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals])
- Length of Hospital Stays During the Overall Period(Maximum 164 weeks)
- Occurrence of at Least 1 Emergency Room Visit During the Treatment Period(Maximum 152 weeks)
- Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period(Maximum 12 weeks)
- Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals](Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals])
- Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals](Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals])
- Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period(Maximum 12 weeks)
- Occurrence of at Least 1 Hospital Stay During the During the Overall Period(Maximum 164 weeks)
- Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period(Maximum 164 weeks)
- Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period(Maximum 12 weeks)
- Occurrence of at Least 1 General Concomitant Medication During the Overall Period(Maximum 164 weeks)
- Occurrence of at Least 1 Hospital Stay During the Treatment Period(Maximum 152 weeks)
- Length of Hospital Stays During the Treatment Period(Maximum 152 weeks)
- Occurrence of at Least 1 Emergency Room Visit During the Overall Period(Maximum 164 weeks)
- Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study(Maximum 154 weeks)
- Occurrence of at Least 1 Hospital Stay During the Follow-Up Period(Maximum 12 weeks)
- Length of Hospital Stays During the Follow-Up Period(Maximum 12 weeks)
- Occurrence of at Least 1 General Concomitant Medication During the Treatment Period(Maximum 152 weeks)
- Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period.(Maximum 152 weeks)
- Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period(Maximum 152 weeks)
- Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period(Maximum 12 weeks)
- Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period(Maximum 164 weeks)
研究者
研究点 (64)
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