Registry of Etanercept Use in Patients With Rheumatoid Arthritis in Clinical Practice in Taiwan

Rheumatoid Arthritis Clinical Trial

Official title:

A Registry Study to Describe the Implications of Therapeutic Management of Etanercept in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888576
• Other study ID #: 0881A1-4445
• Status: Completed
• Phase: N/A
• First received: April 24, 2009
• Last updated: February 7, 2012
• Start date: December 2008
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthTaiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Taiwan	Pfizer Investigational Site	Changhua
Taiwan	Pfizer Investigational Site	Changhua City	Changhua County
Taiwan	Pfizer Investigational Site	Dalin	Chia-Yi
Taiwan	Pfizer Investigational Site	Hualien
Taiwan	Pfizer Investigational Site	Kaohsiung
Taiwan	Pfizer Investigational Site	Kaohsiung
Taiwan	Pfizer Investigational Site	Keelung
Taiwan	Pfizer Investigational Site	Kuei Shan	Taoyuan
Taiwan	Pfizer Investigational Site	Lukang Zhen	Changhua
Taiwan	Pfizer Investigational Site	Niao Sung Hsiang	Kaohsiung
Taiwan	Pfizer Investigational Site	Putz	Chiayi
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Tainan
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei TOC
Taiwan	Pfizer Investigational Site	Taoyuan
Taiwan	Pfizer Investigational Site	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes

External Links

•   To obtain contact information for a study center near you, click here.