A long-term, open-label study of TNR-001 in Japanese Juvenile Idiopathic Arthritis Subjects.

Wyeth Kabushiki Kaisha (Wyeth K.K.)0 个研究点目标入组 32 人开始时间: 2015年3月12日最近更新: 2015年3月16日

试验速览

暂无简介。

•1. Subjects who completed the 204, 206-JA or 208-JA studies didn’t have any safety concern in the previous studies, and the investigator judged it was proper them to be move to this study.
•2. The subjects have consented to practice proper contraception during the study, if male children of reproductive capacity or female children of child-bearing potential.
•3. The subjects have given informed assent to participate in the study, and whose legal guardian has given informed consent. For children under 7 years of age, the acquisition of informed assent may not necessarily be required.
•4. The subjects should have legal guardians who can properly manage the storage and administration of the test article and can accurately record the time of administration, and the physical condition of the subject, etc. in the patient diary.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 32
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 4
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Subjects who failed to meet the restrictive conditions regarding concomitant medications or treatment.
•2. Any others judged ineligible for participation in the study by the investigator or the sub-investigator.
•3. Subjects with a present or past psychiatric disorder that may obstruct compliance with the protocol or acquisition of informed consent or assent and patients whose legal guardian has any present or past psychiatric disorder that may obstruct compliance with the protocol or the acquisition of informed consent.
•4. Subjects who are unable to abide by the requirements of the study, and patients whose legal guardian is unable to abide by the requirements.

发起方

Wyeth Kabushiki Kaisha (Wyeth K.K.)