Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)

Completed

• Conditions: Arthritis; Rheumatoid
• Interventions: Drug: etanercept (genetical recombination)

• Registration Number: NCT01230177
• Lead Sponsor: Pfizer

Brief Summary

This survey is conducted to investigate safety and efficacy under the post marketed drug utilization on the patient with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy) at the time of switching regimen from 10 mg twice a week administration to 25 mg once a week administration.

Detailed Description

Implemented as a Special Investigation by Central Registration System

Study Timeline

• Study First Submitted: 2010-10-27
• Study First Submitted QC: 2010-10-27
• Study First Posted: 2010-10-28
• Study Start: 2011-05
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2014-03-27
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-03
• Last Update Submitted: 2017-01-03
• Results First Posted: 2017-02-23
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Patients need to be administered etanercept in order to be enrolled in the survey
• Patients who have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.

Exclusion Criteria

• Patients who have been administered etanercept 50mg once a week
• Patients who have been administered etanercept 25mg once a week

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Etanercept (genetical recombination)	etanercept (genetical recombination)	Among the patients with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy), the patients who will have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Related Adverse Events	12 weeks	Adverse events are defined as any unfavorable events, including clinically significant abnormal changes in laboratory test values, which develop in participants after the administration of etanercept regardless of the causal relationship to etanercept. The causal relationship between an adverse event and etanercept was evaluated by the sponsor.
Change in Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])	12 weeks	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.; DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, 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.
Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])	12 weeks	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.; DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, 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.

Secondary Outcome Measures

Name	Time	Method
Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values	12 weeks	On the basis of how well the clinical symptoms of rheumatoid arthritis were controlled at baseline, the physician assessed the clinical effect of etanercept in two grades: "effective" or "ineffective". To assess the clinical efficacy of etanercept, the degrees of the symptoms of rheumatoid arthritis and laboratory test values were compared between at baseline and at the 12th week of the investigation.

Trial Locations

Locations (1)

Taihaku Sakura Hospital; 🇯🇵 Sendai, Miyagi, Japan