children with juvenile idiopathic arthritis MedDRA version: 9.1 Level: LLT Classification code 10059176 Term: Juvenile idiopathic arthritis
Conditions
Interventions
Trade Name: Enbrel®
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
Asklepios-Klinik Sankt Augustin
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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%.) ;Secondary Objective: safety which is measured by rates of serious adverse events (SAEs) and adverse events.;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). | — |
Countries
Germany
Outcome results
None listed