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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Changhua, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

None

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Apr 27, 2009
Registry last updated: Feb 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed