Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
NCT00913458
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- Diagnosis of early rheumatoid arthritis.
- Methotrexate (MTX) naive.
- Active early rheumatoid arthritis at the time of enrollment.
- Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF)
inhibitors, or other biologic agents.
- Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), within
4 weeks before baseline.
- Concurrent treatment with more than 1 non-steroidal anti-inflammatory drug (NSAID) at
baseline.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis | |||
Official Title ICMJE | A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate | |||
Brief Summary | Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE | Drug: etanercept
Other Name: Enbrel | |||
Study Arms ICMJE | Experimental: 1
etanercept + methotrexate; etanercept + methotrexate Intervention: Drug: etanercept | |||
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 | 306 | |||
Original Estimated Enrollment ICMJE | 300 | |||
Actual Study Completion Date ICMJE | December 2012 | |||
Actual Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
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 | France, Germany, Ireland, Italy, Monaco, Netherlands, Poland, Qatar, Romania, Russian Federation, Spain, Switzerland, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00913458 | |||
Other Study ID Numbers ICMJE | 0881X1-4524 B1801020 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | July 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |