EUCTR2009-011763-37-IT进行中（未招募）不适用
THE ANTI-ANGIOGENIC EFFECTS OF ADALIMUMAB INCROHN`S DISEASE - ND
ISTITUTO CLINICO HUMANITAS0 个研究点开始时间: 2009年4月16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
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 subject will be eligible for study participation if he/she meets the following criteria:
- •1. Diagnosis of moderate to severe Crohn`s Disease confirmed by endoscopy or radiologic evaluation for greater than 4 months
- •(16 weeks).
- •2. According to Italian summary of product characteristics .
- •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
- •A subject will be excluded from the study if he/she meets any of the following criteria:
- •A subject will be excluded from the study if he/she meets any of the following criteria:
- •1. History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal
- •cell carcinoma or carcinoma − in-situ of the cervix.
- •2. History of listeria, human immunodeficiency virus (HIV), chronic or active Hepatitis B, an immunodeficiency syndrome, central
- •nervous system (CNS) demyelinating disease or active TB.
- •3. Subject with a current diagnosis of ulcerative colitis or indeterminate colitis as determined by the investigator
- •4. Subject with symptomatic known obstructive strictures.
- •5. Subjects with abscess or suspicion of abscess, defined as fever and/or anal pain.
- •6. Subject who has had surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled
- •in the study.
- •7. Subject with an ostomy or ileoanal pouch.
- •8. Subject who has short bowel syndrome as determined by the investigator.
- •9. Subject who is currently receiving total parenteral nutrition (TPN).
- •10. Females who are pregnant or will not discontinue breast-feeding.
- •11. Subject who has received any investigational chemical agent in the past 30 days or 5 half-lives prior to Baseline (whichever is
- •12. Subject who has received any investigational biological agent within 5 half-lives prior to Baseline.
- •13. Subject who has an active infection or has had systemic antibiotic, antiviral, or antifungal treatment within 3 weeks prior to Baseline
- •for infection. Subjects are allowed to be on ciprofloxacin or metronidazole for their non-infectious Crohn`s symptoms.
- •14. Subject with a history of clinically significant drug or alcohol abuse in the last year.
- •15. Subjects with a poorly controlled medical condition such as: uncontrolled diabetes with documented history of recurrent infections,
- •unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the
- •opinion of the investigator or the sponsor, would put the subject at risk by participation in the protocol.
- •16. Subjects with positive C. difficile stool assay.
- •17. Subject who has previously used infliximab or any anti-TNF within 8 weeks of Baseline.
- •18. Previous treatment with adalimumab or previous participation in an adalimumab clinical study.
- •19. Screening laboratory and other analyses show any of the following abnormal results:
- •● Electrocardiogram (ECG) - with clinically significant abnormalities;
- •● Aspartate transaminase (AST) or alanine transaminase (ALT) >1.75 x the upper limit of the reference range;
研究者
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