Overview
Open Label, Dose-Regimen Study Evaluating Etanercept 50 mg Once-Weekly In Japanese Subjects With RA
Status:
Completed
Completed
Trial end date:
2007-12-01
2007-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of PfizerTreatments:
Etanercept
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.