Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
NCT ID: NCT00913458
Last Updated: 2014-07-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
306 participants
INTERVENTIONAL
2009-09-30
2012-12-31
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
QUADRUPLE
Study Groups
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1
etanercept + methotrexate; etanercept + methotrexate
etanercept
Interventions
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etanercept
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Methotrexate (MTX) naive.
* Active early rheumatoid arthritis at the time of enrollment.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Lyon, , France
Pfizer Investigational Site
Montpellier, , France
Pfizer Investigational Site
Paris, , France
Pfizer Investigational Site
Paris, , France
Pfizer Investigational Site
Paris, , France
Pfizer Investigational Site
Strasbourg, , France
Pfizer Investigational Site
Toulouse, , France
Pfizer Investigational Site
Vogelsang, Gommern, Germany
Pfizer Investigational Site
Altona, , Germany
Pfizer Investigational Site
Elmshorn, , Germany
Pfizer Investigational Site
Halle, , Germany
Pfizer Investigational Site
Halle, , Germany
Pfizer Investigational Site
Hamburg, , Germany
Pfizer Investigational Site
Ludwigsfelde, , Germany
Pfizer Investigational Site
München, , Germany
Pfizer Investigational Site
Osnabrück, , Germany
Pfizer Investigational Site
Rostock, , Germany
Pfizer Investigational Site
Würzburg, , Germany
Pfizer Investigational Site
Zerbst, , Germany
Pfizer Investigational Site
Dublin, Ireland, Ireland
Pfizer Investigational Site
Pavia, , Italy
Pfizer Investigational Site
Pisa, , Italy
Pfizer Investigational Site
Monaco, , Monaco
Pfizer Investigational Site
Amsterdam, North Holland, Netherlands
Pfizer Investigational Site
Haarlem, , Netherlands
Pfizer Investigational Site
Heerlen, , Netherlands
Pfizer Investigational Site
Ustroń, Poland, Poland
Pfizer Investigational Site
Warsaw, Poland, Poland
Pfizer Investigational Site
Żyrardów, Poland, Poland
Pfizer Investigational Site
Bydgoszczy, , Poland
Pfizer Investigational Site
Poznan, , Poland
Pfizer Investigational Site
Torun, , Poland
Pfizer Investigational Site
Warsaw, , Poland
Pfizer Investigational Site
Wroclaw, , Poland
Pfizer Investigational Site
Doha, Qatar, Qatar
Pfizer Investigational Site
Bucharest, Romania, Romania
Pfizer Investigational Site
Bucharest, Romania, Romania
Pfizer Investigational Site
Bucharest, , Romania
Pfizer Investigational Site
Bucharest, , Romania
Pfizer Investigational Site
Bucharest, , Romania
Pfizer Investigational Site
Bucharest, , Romania
Pfizer Investigational Site
Târgu Mureş, , Romania
Pfizer Investigational Site
Yaroslavl, , Russia
Pfizer Investigational Site
Barcelona, Barcelona, Spain
Pfizer Investigational Site
A Coruña, La Coruna, Spain
Pfizer Investigational Site
Madrid, Madrid, Spain
Pfizer Investigational Site
Oviedo, Principality of Asturias, Spain
Pfizer Investigational Site
Barcelona, Spain, Spain
Pfizer Investigational Site
Valencia, Valencia, Spain
Pfizer Investigational Site
Sankt Gallen, Canton of St. Gallen, Switzerland
Pfizer Investigational Site
Chur, , Switzerland
Pfizer Investigational Site
Lausanne, , Switzerland
Pfizer Investigational Site
Wigan, Lancaster, United Kingdom
Pfizer Investigational Site
Manchester, Manchester, United Kingdom
Pfizer Investigational Site
Harrogate, North Yorkshire, United Kingdom
Pfizer Investigational Site
Dudley, West Midlands, United Kingdom
Pfizer Investigational Site
Leeds, West Yorkshire, United Kingdom
Pfizer Investigational Site
London, , United Kingdom
Pfizer Investigational Site
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Tanaka Y, Smolen JS, Jones H, Szumski A, Marshall L, Emery P. The effect of deep or sustained remission on maintenance of remission after dose reduction or withdrawal of etanercept in patients with rheumatoid arthritis. Arthritis Res Ther. 2019 Jul 5;21(1):164. doi: 10.1186/s13075-019-1937-4.
Fleischmann RM, van der Heijde D, Gardiner PV, Szumski A, Marshall L, Bananis E. DAS28-CRP and DAS28-ESR cut-offs for high disease activity in rheumatoid arthritis are not interchangeable. RMD Open. 2017 Jan 30;3(1):e000382. doi: 10.1136/rmdopen-2016-000382. eCollection 2017.
Zhang W, Bansback N, Sun H, Pedersen R, Kotak S, Anis AH. Impact of etanercept tapering on work productivity in patients with early rheumatoid arthritis: results from the PRIZE study. RMD Open. 2016 Jul 7;2(2):e000222. doi: 10.1136/rmdopen-2015-000222. eCollection 2016.
Wiland P, Dudler J, Veale D, Tahir H, Pedersen R, Bukowski J, Vlahos B, Williams T, Gaylord S, Kotak S. The Effect of Reduced or Withdrawn Etanercept-methotrexate Therapy on Patient-reported Outcomes in Patients with Early Rheumatoid Arthritis. J Rheumatol. 2016 Jul;43(7):1268-77. doi: 10.3899/jrheum.151179. Epub 2016 Jun 1.
Zhang W, Bansback N, Sun H, Pedersen R, Kotak S, Anis AH. Estimating the monetary value of the annual productivity gained in patients with early rheumatoid arthritis receiving etanercept plus methotrexate: interim results from the PRIZE study. RMD Open. 2015 Apr 8;1(1):e000042. doi: 10.1136/rmdopen-2014-000042. eCollection 2015.
Emery P, Hammoudeh M, FitzGerald O, Combe B, Martin-Mola E, Buch MH, Krogulec M, Williams T, Gaylord S, Pedersen R, Bukowski J, Vlahos B. Sustained remission with etanercept tapering in early rheumatoid arthritis. N Engl J Med. 2014 Nov 6;371(19):1781-92. doi: 10.1056/NEJMoa1316133.
Related Links
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Other Identifiers
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B1801020
Identifier Type: -
Identifier Source: secondary_id
0881X1-4524
Identifier Type: -
Identifier Source: org_study_id
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