E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
children with juvenile idiopathic arthritis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059176 |
E.1.2 | Term | Juvenile idiopathic arthritis |
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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 |
evaluation of the efficacy and safety of high dose of etanercept 0.8 mg/kg bw once per week instead of 0.4 mg/kg/bw twice per week by the ACR Pediatric 30 criteria for improvement and standard measures of disease activity. (The ACR Pediatric 30 criteria are defined as improvement of > or = 30% in at least 3 of 6 core response variables used to assess disease activity, with no more than 1 variable worsening by > or = 30%.) |
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E.2.2 | Secondary objectives of the trial |
safety which is measured by rates of serious adverse events (SAEs) and adverse events. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
signed informed consent form; age 4 and older but not 18 years; boys and girls, but girls only after a negative pregnancy test and confirmation for sexual abstinence; patients and parent can and will follow the study procedures; diagnosis of juvenile idiopathic arthritis with polyarticular beginning or with oligoarticular start and transition into polyarthritis; patients with a psoriasis associated arthritis and enthesitis associated arthritis; naiv patients for Etanercept, Adalimumab or Infliximab; active polyarthritis with at least 5 joints involves with inflammination or movement limited with joint pain after pressure or movement; disaese is refractory for a therapy with methotrexate |
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E.4 | Principal exclusion criteria |
excluded are: systemic juvenile idiopathic arthritis; patients that had an active uveitis during the last 4 weeks; pregnant females or lactating patients; girls without contraception; active or chronic infection especially patients with Hepatitis B or C; patients who had a severe bacterial infection during the last 3 months; patients with diagnosis of the tuberculosis or other infections like Herpes zoster; patients with malignancy, patients with other chronic diseases (kidney, liver, etc.) too severe to included the patients into the study; patients had a significant disease 28 days before the application of the study medication is planned; patients with drug or alcohol misuse; patients took medication like: Anakinra, Rituximab, Abatacept, Adalimumab, Etanercept, Infliximab; patients with special medication taken for a defined time; special dose of corticosteroids; vaccination planned two weeks before study medication application and within the coming 12 weeks; patients participated 4 weeks before this study in another trial, will do this during this trial or plans to do it within 4 weeks after this trial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
ACR 30 Pediatric criteria; number of swollen joints, number of "active joints" (joints with swelling); degree of pain on a visual-analogue scale for the patient; degree of pain on a visual-analogue scale for the physician; assessment of QoL by the CHAQ 1 + 2; ESR (sedimentation rate). |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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
|
the trial lasts 12 weeks for each patient and the complete trial will by ended when the last included subject finished the 12 weeks visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 15 |
E.8.9.1 | In the Member State concerned days | |