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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00888576

Enrollment

441

Registered

2009-04-27

Start date

2008-12-31

Completion date

2011-12-31

Last updated

2012-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Taiwan

Outcome results