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

An Open-label, Multicenter, Dose-regimen Study Evaluating the Efficacy and Safety of Etanercept 50 mg Once-weekly Dose in Japanese Subjects With Rheumatoid Arthritis

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.

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Drug: etanercept

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aomori
    • Nunoya-cho Goshogawara, Aomori, Japan, 037-0053
  • Fukuoka
    • Kokubu, Kurume, Fukuoka, Japan, 839-0863
  • Gunma
    • Inomachi Takasaki, Gunma, Japan, 370-0004
  • Hyogo
    • Higashiuneno Kawanishi, Hyogo, Japan, 666-0195
    • Mukogawa-cho, Nishinomiya, Hyogo, Japan, 663-8501
  • Ibaraki
    • Kamiyokoba, Tsukuba, Ibaraki, Japan, 305-0854
  • Mie
    • Douhaku, Suzuka, Mie, Japan, 513-0824
    • Hazama, Isobe-cho, Shima, Mie, Japan, 517-0214
    • Hisai Myojin-cho, Tsu, Mie, Japan, 514-1101
  • Nagasaki
    • Yamato, Sasebo, Nagasaki, Japan, 857-1195
  • Okayama
    • Higashizuka, Kurashiki, Okayama, Japan, 712-8044
  • Tokyo
    • Toranomon, Minato-ku, Tokyo, Japan, 105-0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Arm 1: Period A-25mg BW; Arm 1: Period B-50mg QW	Drug: etanercept; Period A: Weeks 1-4: Etanercept 25mg (25mg vial)bi-weekly (BW); Period B: Weeks 5-12: Etanercept 50mg (50mg vial) weekly (QW)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Activity Score Using 28-joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4ESR) by Treatment Period.	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).	weeks 4 and 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-Time Curve (AUC)	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.	7 days after week 4 and 7 days after week 12

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: January 2, 2007
• First Submitted That Met QC Criteria: January 4, 2007
• First Posted (Estimate): January 5, 2007

Study Record Updates

• Last Update Posted (Estimate): March 2, 2012
• Last Update Submitted That Met QC Criteria: March 1, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: 0881A1-321