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.Estudio multicéntrico abierto del anticuerpo monoclonal anti-TNF humano Adalimumab para evaluar la seguridad y la tolerabilidad a largo plazo de la administración repetida de Adalimumab en sujetos con enfermedad de Crohn.

Abbott GmbH & Co. KG0 个研究点目标入组 960 人开始时间: 2005年6月7日最近更新: 2013年6月10日

研究概览

暂无简介。

•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

•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.

发起方