Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan

Study Overview
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Brief Summary
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The special use-results surveillance is conducted in patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use after marketing with the following objectives: 1. To examine the safety of long-term use of Enbrel including the occurrence of malignant tumors. 2. To confirm the efficacy of Enbrel in the long-term use.

Official Title
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Enbrel Special Use Result Surveillance

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Enbrel (etanercept)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria Patients with rheumatoid arthritis (RA) who fulfill all of the following Patients who are refractory to the treatment. Patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted. Patients without a history of or concurrent malignant tumors. Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 10 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

| Intervention/Treatment |
| --- |
|Drug: Enbrel (etanercept)|Enbrel 10 to 25 mg twice a week subcutaneous injection|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants in Safety Analysis Population of Etanercept |  | 3 years | 
| 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. | 3 years | 
| 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-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder. | 3 years | 
| Number of Participants With 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. | 3 years | 
| European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (4/Erythrocyte Sedimentation Rate: ESR) | DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Health Assessment Questionnaire (mHAQ) Score | Modified Health Assessment Questionnaire-(mHAQ): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. | 2 years | 
| Visual Analog Fatigue Scale (VAFS) | Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. | 2 years | 
| European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (3/Erythrocyte Sedimentation Rate: ESR) | DAS28-3 (ESR) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count and ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission. | 2 years |