Study Evaluating the Efficacy and Safety of Etanercept in Chinese Subjects With Rheumatoid Arthritis
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Etanercept in Chinese Subjects With Active Rheumatoid Arthritis Receiving Methotrexate
1 other identifier
interventional
150
1 country
6
Brief Summary
The objective of this study is to compare in Chinese subjects with rheumatoid arthritis (RA) the efficacy and safety in this subject population of 50 mg once-weekly injections of etanercept versus placebo in subjects receiving methotrexate. This is a multi-center, double-blind, randomized, parallel and placebo-controlled outpatient study. Approximately 150 subjects will participate in this study for about 18 weeks including a screening period up to 4 weeks, 12-week treatment period, and a 2-week follow-up period at approximately 25 sites.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2006
Shorter than P25 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 5, 2007
CompletedFirst Posted
Study publicly available on registry
March 7, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedDecember 13, 2007
December 1, 2007
March 5, 2007
December 11, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint is ACR20 response at 12 weeks.
Secondary Outcomes (9)
Physician global assessments
Morning stiffness in minutes
Pain visual analog scale(VAS)
Health assessment questionnaire(HAQ)
C-reactive protein (CRP) values, Subject global assessments
- +4 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Must be of Chinese ancestry and living in China.
- Meets the American Rheumatism Association 1987 Revised Criteria for the Classification of RA.
- Have active RA at the time of study enrollment (before the start of the screening period,) as demonstrated by 5 swollen and 5 tender/painful joints.
You may not qualify if:
- Previous receipt of etanercept; antibody to tumor necrosis factor (TNF) antibody (infliximab, adalimumab), anti-CD4 antibody or diphtheria IL-2 fusion protein (DAB IL-2).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Beijing, 100029, China
Unknown Facility
Beijing, 100044, China
Unknown Facility
Beijing, 100853, China
Unknown Facility
Guangzhou, 510275, China
Unknown Facility
Shanghai, 200001, China
Unknown Facility
Xi'an, 710032, China
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
March 5, 2007
First Posted
March 7, 2007
Study Start
June 1, 2006
Study Completion
July 1, 2007
Last Updated
December 13, 2007
Record last verified: 2007-12