Clinical trial NCT00888576: Registry of Etanercept Use in Patients With Rheumatoid Arthritis in Clinical Practice in Taiwan
Official title: A Registry Study to Describe the Implications of Therapeutic Management of Etanercept in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-27
Enrollment: 441
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: clinic

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 24 weeks
Secondary outcomes:
measure: 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.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
facility: Pfizer Investigational Site
state: Changhua County
city: Lukang Zhen
country: Taiwan
facility: Pfizer Investigational Site
state: Changhua
city: Dalin
country: Taiwan
facility: Pfizer Investigational Site
state: Chia-Yi
city: Putz
country: Taiwan
facility: Pfizer Investigational Site
state: Chiayi
city: Niao Sung Hsiang
country: Taiwan
facility: Pfizer Investigational Site
state: Kaohsiung
city: Kuei Shan
country: Taiwan
facility: Pfizer Investigational Site
state: Taoyuan
city: Changhua
country: Taiwan
facility: Pfizer Investigational Site
city: Hualien
country: Taiwan
facility: Pfizer Investigational Site
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Keelung
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei TOC
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taoyuan
country: Taiwan
facility: Pfizer Investigational Site
city: Taoyuan
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: