E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Juvenile idiopathic arthritis (JIA) |
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E.1.1.1 | Medical condition in easily understood language |
Joint inflammation in children |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Assess the safety of the long-term administration of
TNR-001 in subjects with active polyarticular-course JIA.
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy of the long-term administration of TNR-001 in patients with active polyarticular-course JIA |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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) |
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E.5.1.1 | 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 |
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E.5.2 | 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 |
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial days | 10 |