Open Label, Dose-Regimen Study Evaluating Etanercept 50 mg Once-Weekly In Japanese Subjects With RA

Phase 3

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: etanercept

• Registration Number: NCT00418717
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The primary purpose of this study is to evaluate the safety and efficacy of a once-weekly dose of etanercept for rheumatoid arthritis. Currently, patients in Japan can only use 25 mg etanercept two times a week. If a once-a-week regimen of 50 mg is approved, this would be more convenient for most patients. This once-weekly regimen is used in countries outside of Japan.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-01-02
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-05
• Study Start: 2007-02
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2008-12-19
• Results First Submitted QC: 2010-04-08
• Results First Posted: 2010-05-04
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-01
• Last Update Posted: 2012-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Subjects of Japanese ancestry and living in Japan.
• Subjects who are receiving the approved dose of 25 mg etanercept BIW for at least 6 months and have stable disease activity, as determined by investigator's judgment for 3 months before test articles administration.
• Subjects who have mildly active rheumatoid arthritis as demonstrated by 5 swollen joints and 5 tender/painful joints.

Main

Exclusion Criteria

• Prior treatment with Disease Modifying Anti-Rheumatic Drugs (DMARDs) and/or methotrexate (MTX) within 6 months of the baseline visit.
• Subjects considered being in disease remission, per investigator's judgment.
• Received other biological drugs, rituximab, anti-CD-4 agents, or diphtheria interleukin-2 fusion protein (DAB-IL-2) within 6 months prior to baseline.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	etanercept	Arm 1: Period A-25mg BW; Arm 1: Period B-50mg QW

Primary Outcome Measures

Name	Time	Method
Disease Activity Score Using 28-joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4ESR) by Treatment Period.	weeks 4 and 12	DAS28-4ESR is a clinical index of rheumatoid arthritis disease activity based on information from swollen joints, tender joints, acute phase response (Erythrocyte Sedimentation Rate) and general health. DAS28-4ESR scores range from 0 - 10, where a score of less than or equal to 3.2 implies well controlled disease and greater than or equal to 5.1 implies active disease. In this analysis, the DAS28-4ESR is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12).

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-Time Curve (AUC)	7 days after week 4 and 7 days after week 12	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. In this analysis, the AUC is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12). Blood samples were taken on day 0 of PK analysis and collected every day after for 7 days for weeks 4 and 12.