Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis.
NCT00393471
Last updated date
ABOUT THIS STUDY
To compare the therapeutic and radiographic effects and safety between etanercept,
methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid
arthritis.
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.
Active Rheumatoid Arthritis
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
NEED INFO?
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ALL GENDERS
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years
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Active Rheumatoid ArthritisStudy Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis.
NCT00393471
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Advanced Information
| Descriptive Information | ||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis. | |||||||||||||||||||||||||||||||||||||||||||||
| Official Title ICMJE | A Double-Blind Study Evaluating the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Comparison to Etanercept Alone or Methotrexate Alone in Rheumatoid Arthritis Patients. | |||||||||||||||||||||||||||||||||||||||||||||
| Brief Summary | To compare the therapeutic and radiographic effects and safety between etanercept, methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid arthritis. | |||||||||||||||||||||||||||||||||||||||||||||
| Detailed Description | Etanercept is an injection administered under the skin twice weekly. Methotrexate is a tablet to be taken once weekly. Patients will not know which treatment they are on. Patients will need to meet the study criteria to be enrolled in the study and sign an informed consent. | |||||||||||||||||||||||||||||||||||||||||||||
| Study Type ICMJE | Interventional | |||||||||||||||||||||||||||||||||||||||||||||
| Study Phase ICMJE | Phase 3 | |||||||||||||||||||||||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||||||||||||||||||||||||||||||||||||||||||||
| Condition ICMJE | Active Rheumatoid Arthritis | |||||||||||||||||||||||||||||||||||||||||||||
| Intervention ICMJE | Drug: Etanercept | |||||||||||||||||||||||||||||||||||||||||||||
| Study Arms ICMJE | Not Provided | |||||||||||||||||||||||||||||||||||||||||||||
| Publications * |
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* 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 | |||||||||||||||||||||||||||||||||||||||||||||
| Enrollment ICMJE | 615 | |||||||||||||||||||||||||||||||||||||||||||||
| Original Enrollment ICMJE | Same as current | |||||||||||||||||||||||||||||||||||||||||||||
| Study Completion Date ICMJE | October 2001 | |||||||||||||||||||||||||||||||||||||||||||||
| Primary Completion Date | Not Provided | |||||||||||||||||||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion: - Generally healthy of at least 18 years of age with active rheumatoid arthritis. Exclusion: - A history or presence of clinically important medical disease. | |||||||||||||||||||||||||||||||||||||||||||||
| Sex/Gender ICMJE |
| |||||||||||||||||||||||||||||||||||||||||||||
| Ages ICMJE | 18 Years and older (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 | Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, United Kingdom | |||||||||||||||||||||||||||||||||||||||||||||
| Removed Location Countries | ||||||||||||||||||||||||||||||||||||||||||||||
| Administrative Information | ||||||||||||||||||||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT00393471 | |||||||||||||||||||||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | 0881A1-308 | |||||||||||||||||||||||||||||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||||||||||||||||||||||||||||||||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||||||||||||||||||||||||||||||||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||||||||||||||||||||||||||||||||
| Responsible Party | Not Provided | |||||||||||||||||||||||||||||||||||||||||||||
| 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 | October 2006 | |||||||||||||||||||||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||||||||||||||||||||||||||||||||||||||