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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00503139
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-16
• Study First Submitted QC: 2007-07-16
• Study First Posted: 2007-07-18
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2014-03-27
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-09
• Last Update Submitted: 2017-01-09
• Results First Posted: 2017-02-28
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 684

Inclusion Criteria

Inclusion Criteria Patients with rheumatoid arthritis (RA) who fulfill all of the following

1. Patients who are refractory to the treatment.
2. Patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted.
3. Patients without a history of or concurrent malignant tumors.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants in Safety Analysis Population of Etanercept	3 years
Number of Participants With Treatment Related Adverse Events of Etanercept	3 years	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.
Number of Participants With Serious Treatment Related Adverse Events of Etanercept	3 years	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.
Number of Participants With Unlisted Treatment Related Adverse Events of Etanercept	3 years	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.
European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (4/Erythrocyte Sedimentation Rate: ESR)	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Modified Health Assessment Questionnaire (mHAQ) Score	2 years	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.
European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (3/Erythrocyte Sedimentation Rate: ESR)	2 years	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.
Visual Analog Fatigue Scale (VAFS)	2 years	Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.

Trial Locations

Locations (1)

Hokkaido University Hospital; 🇯🇵 Sapporo, Japan