Juvenile idiopathic arthritis (JIA)
Conditions
Interventions
Trade Name: Enbrel
Pharmaceutical Form: Solution for injection in pre-filled syringe
Sponsors
Wyeth Kabushiki Kaisha (Wyeth K.K.)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the efficacy of the long-term administration of TNR-001 in patients with active polyarticular-course JIA;Primary end point(s): Physician’s Global Assessment Subject or Guardians Global Assessment Number of Active Joints Number of Painful Joints on Pressure or Motion Quality of Life Assessd by Childhood Health Assessment Questionnaire (CHAQ) Erythrocyte Sedimentation Rate (ESR);Timepoint(s) of evaluation of this end point: Baseline, Week 12, Week 24, Week 36, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216;Main Objective: Assess the safety of the long-term administration of TNR-001 in subjects with active polyarticular-course JIA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Numbers of Subjects Who Achieved Juvenile Rheumatoid Arthritis (JRA) 30 percent (%)Definition of Improvement (DOI), 50 % DOI And 70 % DOI Percent Change of the JRA Core Set and Other Disease Activity Variables;Timepoint(s) of evaluation of this end point: Baseline, Week 12, Week 24, Week 36, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216 | — |
Countries
Japan
Contacts
Public ContactPfizer Japan Inc.
Pfizer Japan Inc.
Outcome results
None listed