EUCTR2015-001834-15-ES进行中（未招募）1 期
An open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn's disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 62
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
入选标准
- •- Patients with Crohn`s disease, who have successfully completed the preceding trial 1311.6. Successful treatment is defined as:
- •a. Completion of period 2 in 1311.6 with a clinical response (drop in Crohn's Disease Activity Index from baseline by =100) but no remission (Crohn's Disease Activity Index < 150) at Visit E1; or
- •b. Completion of period 3 in 1311.6 with a clinical response (drop in Crohn's Disease Activity Index from baseline by =100) or remission (Crohn's Disease Activity Index < 150) at Visit E5; or
- •c. Completion of period 2 or 3 in 1311.6 per protocol with a clinical response or remission before initiation of 1311.20 can roll-over either directly or through an open-label i.v. re-induction phase.
- •- Female patients:
- •a. Women of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause), that, if sexually active agree to use one of the appropriate medically accepted methods of birth control in addition to the consistent and correct use of a condom from date of screening until 15 weeks after last administration of study medication. Medically accepted methods of contraception are: ethinyl estradiol containing contraceptives, diaphragm with spermicide substance, and intra-uterine-device, or
- •b. Surgically sterilized female patients with documentation of prior hysterectomy, tubal ligation or complete bilateral oophorectomy, or
- •c. Postmenopausal women with postmenopausal is defined as permanent cessation = 1 year of previously occurring menses, and
- •d. Negative serum ß-Human Chorionic Gonadotrophin test at screening and urine pregnancy test prior to randomization.
- •Male patients:
- •a. Who are documented to be sterile, or
- •b. Who consistently and correctly use effective method of contraception (i.e. condoms) during the study and 15 weeks after last administration of study medication.
- •- Be able to adhere to the study visit schedule and other protocol requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Patients who were not compliant with key study procedures (colonoscopy, treatment compliance, endpoint assessment, contraception measures) in preceding trial 1311.6
- •- Patients who could not tolerate BI 655066 treatment for tolerability or safety reasons in the preceding trial
- •- Are pregnant, nursing, or planning pregnancy while enrolled in the study, or within 15 weeks after receiving the last dose of study medication.
- •- Patients must agree not to receive a live virus or bacterial or Bacille Calmette-Guérin vaccination during the study or up to 12 months after the last administration of study drug.
- •- Patients who have developed malignancy, or suspicion of active malignant disease during the preceding trial
- •- Are intending to participate in any other study using an investigational agent or procedure during participation in this study.
- •- Cannot adhere to the concomitant medication requirements
研究者
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