Registry of Etanercept Use in Patients With Rheumatoid Arthritis in Clinical Practice in Taiwan
A Registry Study to Describe the Implications of Therapeutic Management of Etanercept in Patients With Rheumatoid Arthritis
1 other identifier
observational
441
1 country
23
Brief Summary
The purpose of this study is to develop a registry with safety and efficacy data on the use of etanercept in clinical practice in Taiwan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2008
Typical duration for all trials
23 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
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 24, 2009
CompletedFirst Posted
Study publicly available on registry
April 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFebruary 8, 2012
February 1, 2012
3 years
April 24, 2009
February 7, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Safety: Proportion of patients discontinued from etanercept as a result of an adverse event by Week 24, laboratory exam findings, incidence of adverse events, and vital signs and physical exam findings. Efficacy: Disease Activity Score 28 at week 20.
24 weeks
Secondary Outcomes (1)
Global health assessment; Erythrocyte sedimentation rate; Number of swollen or tender joints; C-reactive protein; Proportion of patients having worsened DAS 28 and components of DAS 28,CRP than baseline; Etanercept approval-lag time.
24 weeks
Study Arms (1)
1
Non-intervention
Eligibility Criteria
clinic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (23)
Pfizer Investigational Site
Changhua, Changhua County, 500, Taiwan
Pfizer Investigational Site
Changhua, Changhua, 500, Taiwan
Pfizer Investigational Site
Lukang Zhen, Changhua, 50544, Taiwan
Pfizer Investigational Site
Dalin, Chia-Yi, 622, Taiwan
Pfizer Investigational Site
Putz, Chiayi, 61363, Taiwan
Pfizer Investigational Site
Kaohsiung City, Kaohsiung, 807, Taiwan
Pfizer Investigational Site
Kaohsiung City, Kaohsiung, 81346, Taiwan
Pfizer Investigational Site
Niao Sung Hsiang, Kaohsiung, 83301, Taiwan
Pfizer Investigational Site
Keelung, Keelung, 204, Taiwan
Pfizer Investigational Site
Taichung, Taichung, 402, Taiwan
Pfizer Investigational Site
Taichung, Taichung, 427, Taiwan
Pfizer Investigational Site
Taipei, Taipei, 14409, Taiwan
Pfizer Investigational Site
Taipei TOC, Taiwan, 100, Taiwan
Pfizer Investigational Site
Guishanli, Taoyuan, 33305, Taiwan
Pfizer Investigational Site
Taoyuan District, Taoyuan, 330, Taiwan
Pfizer Investigational Site
Hualien City, 97002, Taiwan
Pfizer Investigational Site
Taichung, 407, Taiwan
Pfizer Investigational Site
Tainan, 70428, Taiwan
Pfizer Investigational Site
Taipei, 10630, Taiwan
Pfizer Investigational Site
Taipei, 11042, Taiwan
Pfizer Investigational Site
Taipei, 116, Taiwan
Pfizer Investigational Site
Taipei, 220, Taiwan
Pfizer Investigational Site
Taoyuan District, 333, Taiwan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2009
First Posted
April 27, 2009
Study Start
December 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
February 8, 2012
Record last verified: 2012-02