EUCTR2014-004531-39-Outside-EU/EEA进行中（未招募）不适用
A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease.
Abbott Deutschland GmbH & Co. KG0 个研究点目标入组 80 人开始时间: 2014年11月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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. Subjects who successfully enrolled in and completed Study M04-729.
- •2. Subject who can continuously receive isoniazide (INH) for the prophylaxis of latent TB infection if they are receiving INH in Study M04-729 (INH must be administered for 9 months from starting administration of the drug).
- •3. If female, subject is either not of child bearing potential, defined as post menopausal for at least 1 year, 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:
- •- Condoms, sponge, foam, jellies, diaphragm or intrauterine device
- •- Oral contraceptives for three months prior to study drug administration
- •- A vasectomized partner
- •4. If female of child bearing potential, the result of a urine pregnancy test performed at the screening and Week 0 visit are negative.
- •5. Subject must be able and willing to give written informed consent and to comply with the
- •requirements of this study protocol. For the subjects < 20 years old, the subject's parent or legal guardian must be willing to give written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
研究者
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