Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects
NCT ID: NCT00706797
Last Updated: 2011-06-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
141 participants
INTERVENTIONAL
2008-09-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Usual care
Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
methotrexate
ETN + MTX
Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
etanercept (EnbrelTM)
methotrexate
Interventions
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etanercept (EnbrelTM)
methotrexate
Eligibility Criteria
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Inclusion Criteria
* Documented evidence, confirmed by a blinded 3rd party assessor, of at least one erosion observed by X-ray at randomization based on X-ray taken at the screening visit.
* Have received MTX as stable dose for 28 days prior to the screening visit.
Exclusion Criteria
* Receipt of any DMARD, other than MTX, within 28 days before screening.
18 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Wyeth
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Ostrava, , Czechia
Prague, , Czechia
Prague, , Czechia
Amiens, , France
Échirolles, , France
Metz, , France
Montpellier, , France
Paris, , France
Paris, , France
Rouen, , France
Tours, , France
Berlin, , Germany
Cologne, , Germany
Frankfurt, , Germany
Hamburg-Eilbeck, , Germany
Homburg, , Germany
Mainz, , Germany
Budapest, , Hungary
Budapest, , Hungary
Miskolc, , Hungary
Rijeka, , Hungary
Split, , Hungary
Zagreb, , Hungary
Jesi (Ancona), , Italy
Reggio Calabria, , Italy
Bytom, , Poland
Krakow, , Poland
Ustroń, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Santander, Cantabria, Spain
Getafe, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Bilbao, Vizcaya, Spain
Barcelona, , Spain
Madrid, , Spain
Valencia, , Spain
Izmir, , Turkey (Türkiye)
Cambridge, Cambs, United Kingdom
Birmingham, West Midlands, United Kingdom
Aintree, , United Kingdom
Metropolitan Borough of Wirral, , United Kingdom
Newcastle, , United Kingdom
Countries
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References
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Mandl P, Balint PV, Brault Y, Backhaus M, D'Agostino MA, Grassi W, van der Heijde D, de Miguel E, Wakefield RJ, Logeart I, Dougados M. Clinical and ultrasound-based composite disease activity indices in rheumatoid arthritis: results from a multicenter, randomized study. Arthritis Care Res (Hoboken). 2013 Jun;65(6):879-87. doi: 10.1002/acr.21913.
Mandl P, Balint PV, Brault Y, Backhaus M, D'Agostino MA, Grassi W, van der Heijde D, de Miguel E, Wakefield RJ, Logeart I, Dougados M. Metrologic properties of ultrasound versus clinical evaluation of synovitis in rheumatoid arthritis: results of a multicenter, randomized study. Arthritis Rheum. 2012 Apr;64(4):1272-82. doi: 10.1002/art.33491. Epub 2011 Nov 30.
Other Identifiers
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0881X1-4437
Identifier Type: -
Identifier Source: org_study_id
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