Status:
COMPLETED
Open Label, Dose-Regimen Study Evaluating Etanercept 50 mg Once-Weekly In Japanese Subjects With RA
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
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 ti...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00418717
Start Date
February 1 2007
End Date
December 1 2007
Last Update
March 2 2012
Active Locations (12)
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1
Nunoya-cho Goshogawara, Aomori, Japan, 037-0053
2
Kokubu, Kurume, Fukuoka, Japan, 839-0863
3
Inomachi Takasaki, Gunma, Japan, 370-0004
4
Higashiuneno Kawanishi, Hyōgo, Japan, 666-0195