A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis
A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Safety and Efficacy of Etanercept 10 mg Twice Weekly and 25 mg Once Weekly in Japanese Subjects With Active Rheumatoid Arthritis
1 other identifier
interventional
80
1 country
13
Brief Summary
This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 rheumatoid-arthritis
Started Apr 2007
Shorter than P25 for phase_3 rheumatoid-arthritis
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 7, 2007
CompletedFirst Posted
Study publicly available on registry
June 8, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedDecember 5, 2007
December 1, 2007
June 7, 2007
December 3, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary comparison of the study will be the change of DAS28-4ESR scores from baseline (week 0) between the 10 mg BIW group (at week 12) and the 25 mg QW group (at week 12).
Secondary Outcomes (1)
ACR 20, 50, and 70; Number of swollen joints (68 joints); Number of painful joints on pressure or motion (71 joints); Physician global assessment; Patient global assessment; Duration of morning stiffness.
Interventions
Eligibility Criteria
You may qualify if:
- Presence of \>6 swollen joints and \>6 tender joints
- Inadequate response to at least one disease modifying anti-rheumatic drug (DMARD)
- Have not been treated with a DMARD for at least 4 weeks prior to the baseline visit
You may not qualify if:
- Previous treatment with etanercept, antibody to TNFα, or other TNFα inhibitors
- Received investigational drugs within 6 months of the baseline visit
- Received intra-articular hyaluronic acid injections within 4 weeks of the baseline visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Unknown Facility
Goshogawara, Aomori, 037-0053, Japan
Unknown Facility
Choseigun, Chiba, 299-4301, Japan
Unknown Facility
Yotsukaidō, Chiba, 284-0003, Japan
Unknown Facility
Fukuoka, Fukuoka, 810-0001, Japan
Unknown Facility
Fukushima, Fukushima, 960-8251, Japan
Unknown Facility
Higashihiroshima, Hiroshima, 790-0002, Japan
Unknown Facility
Katoh, Hyōgo, 673-1462, Japan
Unknown Facility
Sagamihara, Kanagawa, 228-8522, Japan
Unknown Facility
Kumamoto, Kumamoto, 862-0976, Japan
Unknown Facility
Sendai, Miyagi, 982-0032, Japan
Unknown Facility
Nagano, Nagano, 380-0928, Japan
Unknown Facility
Sasebo, Nagasaki, 857-1195, Japan
Unknown Facility
Ōita, Oita Prefecture, 870-0823, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 7, 2007
First Posted
June 8, 2007
Study Start
April 1, 2007
Study Completion
December 1, 2007
Last Updated
December 5, 2007
Record last verified: 2007-12