Safety and Efficacy Study of the long-term administration of TNR-001 in Subjects with Juvenile Idiopathic Arthritis (JIA)

Conditions: Juvenile idiopathic arthritis (JIA)
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2014-004103-73-Outside-EU/EEA

Lead Sponsor: Wyeth Kabushiki Kaisha (Wyeth K.K.)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 32

Inclusion Criteria

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

Exclusion Criteria

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.