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