EUCTR2004-002163-24-SE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
相关药物
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
- •-Subject must have successfully enrolled in and completed either the M02-404 study or the M04-691 study.
- •-If female, subject is either not of child bearing potential, defined as post menopausal for at least one (1) year prior to the previous study (M02-404 study or the M04-691 study), surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control during the study and for 150 days after the last dose of study medication: -Condoms, sponge, foam, jellies, diaphragm or intrauterine device. -Oral or parenteral contraceptives for three months prior to study drug administration.
- •-If female, subject is not breast-feeding throughout the study and for 150 days after the last dose of study medication.
- •-Subject or his/her legal representative has voluntarily signed and dated an informed consent approved and compliant with the requirements of this study protocol which has been approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- •-Subject must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication.
- •-Subject is judged to be in generally good health as determined by the principal investigator based upon the results of laboratory evaluations and physical examinations done throughout the preceding Crohn's disease study (M02-404 study or the M04-691 study) with adalimumab.
- •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.
- •-Subject with 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.
- •-Subject who 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).
- •-Subjects on 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 (see protocol section 5.2.3).
- •-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 cerebrovascluar accidents and any other condition which, in the opinion of the investigator or sponsor, would put the subject at risk by participating in this study.
研究者
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