Registry of Etanercept Use in Patients With Rheumatoid Arthritis in Clinical Practice in Taiwan
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00888576
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 441
Inclusion Criteria
Main Inclusion Criteria: 1) Male or female patients aged > 20 years; 2) Patients who have already been selected and approved under the Taiwan National Health Insurance Program to receive 24 weeks of etanercept for rheumatoid arthritis. Main
Exclusion Criteria
Exclusion Criteria: None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇳Taoyuan, Taiwan