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

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
etanercept
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Arm 1: Period A-25mg BW; Arm 1: Period B-50mg QW

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
January 2, 2007
Last Updated
March 1, 2012
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00418717
Brief Title
Open Label, Dose-Regimen Study Evaluating Etanercept 50 mg Once-Weekly In Japanese Subjects With RA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Arm 1: Period A-25mg BW; Arm 1: Period B-50mg QW
Intervention Type
Drug
Intervention Name(s)
etanercept
Intervention Description
Period A: Weeks 1-4: Etanercept 25mg (25mg vial)bi-weekly (BW); Period B: Weeks 5-12: Etanercept 50mg (50mg vial) weekly (QW)
Primary Outcome Measure Information:
Title
Disease Activity Score Using 28-joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4ESR) by Treatment Period.
Description
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).
Time Frame
weeks 4 and 12
Secondary Outcome Measure Information:
Title
Area Under the Concentration-Time Curve (AUC)
Description
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.
Time Frame
7 days after week 4 and 7 days after week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Nunoya-cho Goshogawara
State/Province
Aomori
ZIP/Postal Code
037-0053
Country
Japan
City
Kokubu, Kurume
State/Province
Fukuoka
ZIP/Postal Code
839-0863
Country
Japan
City
Inomachi Takasaki
State/Province
Gunma
ZIP/Postal Code
370-0004
Country
Japan
City
Higashiuneno Kawanishi
State/Province
Hyogo
ZIP/Postal Code
666-0195
Country
Japan
City
Mukogawa-cho, Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
City
Kamiyokoba, Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-0854
Country
Japan
City
Douhaku, Suzuka
State/Province
Mie
ZIP/Postal Code
513-0824
Country
Japan
City
Hazama, Isobe-cho, Shima
State/Province
Mie
ZIP/Postal Code
517-0214
Country
Japan
City
Hisai Myojin-cho, Tsu
State/Province
Mie
ZIP/Postal Code
514-1101
Country
Japan
City
Yamato, Sasebo
State/Province
Nagasaki
ZIP/Postal Code
857-1195
Country
Japan
City
Higashizuka, Kurashiki
State/Province
Okayama
ZIP/Postal Code
712-8044
Country
Japan
City
Toranomon, Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-0001
Country
Japan

12. IPD Sharing Statement

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

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