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

Pfizer441 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

441

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (23)

Pfizer Investigational Site

Changhua, Changhua County, Taiwan

Pfizer Investigational Site

Outcomes

Primary Outcomes

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.

Time frame: 24 weeks

Secondary Outcomes

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.

Time frame: 24 weeks

Data from ClinicalTrials.gov

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