Registry of Etanercept Use in Patients With Rheumatoid Arthritis in Clinical Practice in Taiwan
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00888576
First received: April 24, 2009
Last updated: February 7, 2012
Last verified: February 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Etanercept
U.S. FDA Resources
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
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 May 22, 2013