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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00888576
First received: April 24, 2009
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Registry Study to Describe the Implications of Therapeutic Management of Etanercept in Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 441
Study Start Date: December 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Non-intervention

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

clinic

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888576

Locations
Taiwan
Pfizer Investigational Site
Changhua City, Changhua County, Taiwan, 500
Pfizer Investigational Site
Lukang Zhen, Changhua, Taiwan, 50544
Pfizer Investigational Site
Dalin, Chia-Yi, Taiwan, 622
Pfizer Investigational Site
Putz, Chiayi, Taiwan, 61363
Pfizer Investigational Site
Niao Sung Hsiang, Kaohsiung, Taiwan, 83301
Pfizer Investigational Site
Kuei Shan, Taoyuan, Taiwan, 33305
Pfizer Investigational Site
Changhua, Taiwan, 500
Pfizer Investigational Site
Hualien, Taiwan, 97002
Pfizer Investigational Site
Kaohsiung, Taiwan, 807
Pfizer Investigational Site
Kaohsiung, Taiwan, 81346
Pfizer Investigational Site
Keelung, Taiwan, 204
Pfizer Investigational Site
Taichung, Taiwan, 407
Pfizer Investigational Site
Taichung, Taiwan, 427
Pfizer Investigational Site
Taichung, Taiwan, 402
Pfizer Investigational Site
Tainan, Taiwan, 70428
Pfizer Investigational Site
Taipei, Taiwan, 10630
Pfizer Investigational Site
Taipei, Taiwan, 14409
Pfizer Investigational Site
Taipei, Taiwan, 116
Pfizer Investigational Site
Taipei, Taiwan, 220
Pfizer Investigational Site
Taipei, Taiwan, 11042
Pfizer Investigational Site
Taipei TOC, Taiwan, 100
Pfizer Investigational Site
Taoyuan, Taiwan, 330
Pfizer Investigational Site
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00888576     History of Changes
Other Study ID Numbers: 0881A1-4445
Study First Received: April 24, 2009
Last Updated: February 7, 2012
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014