Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance]

Study Overview
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Brief Summary
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This surveillance is conducted to survey the followings under the post marketed drug utilization on the patients who are administrated ENBREL as a treatment for active polyarticular JIA. Primary Occurrence status of Adverse Events; incidence of all adverse events, serious adverse events Secondary Factors affecting safety and to confirm the efficacy such as DAS28.

Detailed Description
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All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year).

Official Title
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Enbrel-JIA Use Results Survey [All-Case Surveillance]

Conditions
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Juvenile Idiopathic Arthritis

Intervention / Treatment
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* Drug: Etanercept (genetical recombination)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in active polyarticular JIA (restricted to the case of lack of effect by other treatment) during enrollment period (2.5years). Patients receiving Enbrel for JIA as diagnosed by a qualified physician. Age 5 - 16 years Exclusion Criteria: Patients not administered ENBREL

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Etanercept (genetical recombination)<br>All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year). | Drug: Etanercept (genetical recombination)<br>* All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis (restricted to the case of lack of effect by other treatment) during registered period (2.5 year).<br>* Other names: Enbrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Related Adverse Events of Etanercept | Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. | 24 weeks | 
| Number of Participants With Serious Treatment-Related Adverse Events of Etanercept | Serious treatment-related adverse events are defined as any events that lead to death, life-thretening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anormaly/congenital deficiency, or other medically significant events or disorder. | 24 weeks | 
| Number of Unlisted Treatment-Related Adverse Events of Etanercept | Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. Unlisted treatment-related adverse events were confirmed with listed adverse drug reactions specified in Japanese package insert. | 24 weeks | 
| Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Overall Improvement On Physician's Assessment. | Percentage of participants in whom the efficacy of etanercept was assessed as either markedly effective or effective. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enbrel-JIA