EUCTR2004-002163-24-DK进行中（未招募）不适用
A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 960
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 patient will be eligible for study participation if he/she meets the following criteria:
- •Patients must have successfully enrolled and completed the M02 - 404 or M04-691 study.
- •Female patients: Must continue to utilize a highly effective method of birth control throughout the study and for 70 days after study completion
- •must not be of childbearing potential, defined as postmenopausal at least two years, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
- •Patients must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
- •Adequate cardiac, renal and hepatic function as determined by principal investigator and demonstrated by screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits.
- •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 this study if he/she did not meet all inclusion criteria or met any of the exclusion criteria from the M02-404 study or the M04 - 691 study. In addition a subject will be excluded from this study if he/she does not complete the M02-404 study or the M04-691 study.
- •Female who is pregnant or breast-feeding will be excluded from this study.
- •For any reason, subject is considered by the investigator to be an unsuitable candidate for continuing therapy in the M04-690 study.
- •Subject has abnormal laboratory or other test results that, in the opinion of the investigator, would make it unsuitable for the subject to participate in this study.
- •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. History of listeria, human immunodeficiency virus (HIV), central nervous system (CNS) demyelinating disease or untreated TB.
- •Subject with ulcerative colitis, symptomatic known obstructive strictures.
- •Subject who has had surgical bowel resections within 6 months prior to the previous study (M02-404 or M04-691) or is planning any resection at any time point while enrolled in the study.
- •Subject with an ostomy or ileoanal pouch.
- •Subject who has short bowel syndrome as determine by the investigator and is currently receiving total parenteral nutrition (TPN).
- •Subject with a history of clinically significant drug or alcohol abuse within one year prior to the previous study (M02-404 or M04-691).
- •Subjects on prednisone > 40 mg/day (or equivalent) or budesonide > 9 mg/day.
- •Subjects currently taking both budesonide and prednisone (or equivalent) are excluded.
- •Subject is not in compliance with prior and concomitant medication requirements
- •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 sponsor, would put the subject at risk by participation in this study.
- •There were no exclusion criteria for this study since patients participated in the M02-404 and M04-691 studies and were screened against the exclusion criteria of that study.
研究者
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