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

Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arthritis, Rheumatoid

Intervention: etanercept (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth


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.

Clinical Details

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 design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Primary outcome: The primary objective is to evaluate the efficacy and safety of etanercept 50 mg QW dose regimen in Japanese RA subjects.

Secondary outcome: Pharmacokinetics


Minimum age: 20 Years. Maximum age: 75 Years. Gender(s): Both.


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.

Locations and Contacts

41,Nunoya-cho Goshogawara, Aomori 037-0053, Japan

155-1, Kokubu, Kurume, Fukuoka 839-0863, Japan

1040, Inomachi Takasaki, Gunma 370-0004, Japan

1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan

5-21-1, Higashiuneno Kawanishi, Hyogo 666-0195, Japan

2573-1 Kamiyokoba, Tsukuba, Ibaraki 305-0854, Japan

375, Hazama, Isobe-cho, Shima, Mie 517-0214, Japan

2065-5, Douhaku, Suzuka, Mie 513-0824, Japan

2158-5 Hisai Myojin-cho, Tsu, Mie 514-1101, Japan

15, Yamato, Sasebo, Nagasaki 857-1195, Japan

5-4-16 Higashizuka, Kurashiki, Okayama 712-8044, Japan

1-1-25, Toranomon, Minato-ku, Tokyo 105-0001, Japan

Additional Information

Starting date: February 2007
Ending date: December 2007
Last updated: December 19, 2007

Page last updated: June 20, 2008

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