Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region
NCT00422227
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Diagnosis of RA
- Currently receiving an adequate dose of methotrexate (MTX) for treatment of RA
- Active RA at time of screening and baseline
- Previous or current treatment with etanercept (ETN), other tumor necrosis factor-alpha
inhibitors, or other biologic agents
- Concurrent treatment with a DMARD, other than MTX, at screening
- Receipt of any DMARD, other than MTX, within 3 months before screening
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Bordeaux,
- Limoges,
- Birmingham, Alabama
- Montpellier,
Descriptive Information | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Brief Title ICMJE | Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region | |||||||||
Official Title ICMJE | A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis | |||||||||
Brief Summary | The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region. | |||||||||
Detailed Description | Not Provided | |||||||||
Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Phase 4 | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||||||||
Condition ICMJE | Rheumatoid Arthritis | |||||||||
Intervention ICMJE |
| |||||||||
Study Arms ICMJE |
| |||||||||
Publications * |
| |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||
Recruitment Information | ||||||||||
Recruitment Status ICMJE | Completed | |||||||||
Actual Enrollment ICMJE | 300 | |||||||||
Original Enrollment ICMJE | Same as current | |||||||||
Actual Study Completion Date ICMJE | March 2009 | |||||||||
Actual Primary Completion Date | March 2009 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||||||||
Sex/Gender ICMJE |
| |||||||||
Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | Hong Kong, India, Korea, Republic of, Malaysia, Philippines, Singapore, Taiwan, Thailand | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT00422227 | |||||||||
Other Study ID Numbers ICMJE | 0881A1-408 | |||||||||
Has Data Monitoring Committee | No | |||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||||||||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
Collaborators ICMJE | Not Provided | |||||||||
Investigators ICMJE |
| |||||||||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
Verification Date | July 2010 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |