Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region
NCT00422227
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Diagnosis of RA
- Currently receiving an adequate dose of methotrexate (MTX) for treatment of RA
- Active RA at time of screening and baseline
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
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Advanced Information
| 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 |
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| 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 | ||||||||||