EUCTR2006-003871-11-DE进行中（未招募）不适用
An open-label, multi-center trial to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). - COSPAR II
CB Pharma S.A.0 个研究点目标入组 352 人开始时间: 2006年10月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 352
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
- •Patients on placebo and/or active drug who were unable to complete corticosteroid tapering or who needed to be restarted on corticosteroids, and patients suffering from Crohn's disease who have successfully completed, in remission, the C87059 trial. Patients able to understand the information provided to them and who have given written informed consent for C87065. If female, the patient is either postmenopausal for atleast one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception( oral or parenteral hormonal contraceptive; intrauterine device; barrier or spermicide-abstinence is not an acceptable method. Patients must agree to use adequate contraception during the trial and for 12 weeks after the last dose of certolizumab. If the patient is on immunosuppresant ( azathioprine, 6-mercaptopurine and methotrexate) are allowed immunosuppresants, the dose has to have been stable during the 8 weeks preceding and throughout the C87059 trial and is expected to remain stable during the extension trial. If the patient is on a 5-ASA analogue for Crohn's disease, the dose has to have been stable during, and for the 4 weeks preceding, the C87059 trial and is expected to remain stable during the extension trial.
- •Are the trial subjects under 18?
- •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
- •Subjects withdrawn or discontinued from the C87059 trial for reasons other than those listed in Inclusion 1. Subject who received treatment other than trial medication and other than medications permitted in the C87059 trial. Subjects from countries where certolizumab pegol is authorised in Crohn's disease treatment. Patients who have developed medical conditions excluded in the C87059 trial will be excluded from participation in C87065. Patients who took permitted antibiotics for conditions other than Crohn's disease in C87059 will be allowed to enter trial C87065 as long as the antibiotic use has not occured within two weeks of entry into C87065.
研究者
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