Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis.


Last updated date
Study Location
St. Leonards, New South Wales, 2065, Australia


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Eligibility Criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Active Rheumatoid Arthritis
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years


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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 *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 26, 2006)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2001
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE


- Generally healthy of at least 18 years of age with active rheumatoid arthritis.


- A history or presence of clinically important medical disease.

Sex/Gender  ICMJE
Sexes Eligible for Study:Male
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
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Australia, [email protected]
Principal Investigator:Trial ManagerFor Austria, [email protected]
Principal Investigator:Trial ManagerFor Belgium, [email protected]
Principal Investigator:Trial ManagerFor Czech Republic, [email protected]
Principal Investigator:Trial ManagerFor Denmark, Finland, Norway, and Sweden, [email protected]
Principal Investigator:Trial ManagerFor France, [email protected]
Principal Investigator:Trial ManagerFor Germany, [email protected]
Principal Investigator:Trial ManagerFor Greece, [email protected]
Principal Investigator:Trial ManagerFor Italy, [email protected]
Principal Investigator:Trial ManagerFor Netherlands, [email protected]
Principal Investigator:Trial ManagerFor Poland, [email protected]
Principal Investigator:Trial ManagerFor Romania, [email protected]
Principal Investigator:Trial ManagerFor Spain, [email protected]
Principal Investigator:Trial ManagerFor UK/Great Britian, [email protected]
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