Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis
NCT ID: NCT00247962
Last Updated: 2012-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
566 participants
INTERVENTIONAL
2005-12-31
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
etanercept
50 mg
B
sulphasalazine (SSZ)
Sulphasalazine: The target dose for SSZ is 1.5 g (3 tablets) twice daily orally. Subject start the oral TA at 0.5 g daily for the first week and increase by 0.5 g every week until a daily dose of 3 g. Is achieved by the start of study week 5 of the study.
Interventions
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etanercept
50 mg
sulphasalazine (SSZ)
Sulphasalazine: The target dose for SSZ is 1.5 g (3 tablets) twice daily orally. Subject start the oral TA at 0.5 g daily for the first week and increase by 0.5 g every week until a daily dose of 3 g. Is achieved by the start of study week 5 of the study.
Eligibility Criteria
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Inclusion Criteria
* Active ankylosing spondylitis
Exclusion Criteria
* Previous treatment with etanercept
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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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Heidelberg West, Victoria, Australia
Shenton Park, Western Australia, Australia
Innsbruck, , Austria
Klagenfurt, , Austria
Linz, , Austria
Beijing, , China
Shanghai, , China
Ostrava, , Czechia
Prague, , Czechia
Frederiksberg, , Denmark
Kolding, , Denmark
Odense, , Denmark
Vejle, , Denmark
Helsinki, , Finland
Kuopio, , Finland
Tampere, , Finland
Amiens, , France
Bordeaux, , France
Boulogne-Billancourt, , France
Créteil, , France
Marseille, , France
Nantes, , France
Orléans, , France
Pierre Mendès, , France
Toulouse, , France
Berlin, , Germany
Berlin, , Germany
Erlangen, , Germany
Gommern, , Germany
Hamburg, , Germany
Herne, , Germany
Heubnerweg, , Germany
Hildesheim, , Germany
München, , Germany
Pirna, , Germany
Ratingen, , Germany
Wiesbaden, , Germany
Wiesbaden, , Germany
Debrecen, , Hungary
Győr, , Hungary
Nyíregyháza, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Wilton, Cork, Ireland
Dublin, , Ireland
Benevento, , Italy
Bergamo, , Italy
Florence, , Italy
Monserrato, , Italy
Potenza, , Italy
Prato, , Italy
Reggio Emilia, , Italy
Roma, , Italy
Roma, , Italy
Amsterdam, , Netherlands
Groningen, , Netherlands
Leeuwarden, , Netherlands
Maastricht, , Netherlands
Nijmegen, , Netherlands
Lodz, , Poland
Ustron Zawodzie, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Doha, , Qatar
Riyadh, , Saudi Arabia
Granollers, Barcelona, Spain
Asturias, , Spain
Barcelona, , Spain
Córdoba, , Spain
Madrid, , Spain
Madrid, , Spain
Porto, , Spain
Santa Cruz de Tenerife, , Spain
Ostra Kyrkogardsgatan, , Sweden
Solna, , Sweden
Upton, Wirral, United Kingdom
Basingstoke, , United Kingdom
Cambridge, , United Kingdom
Cannock, , United Kingdom
Glasgow, , United Kingdom
Liverpool, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Upper Borough Walls, , United Kingdom
Countries
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References
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Baraliakos X, Szumski AE, Kwok KK, Vlahos B, Borlenghi CE. Long-term Etanercept Response for Patients with Radiographic Axial Spondyloarthritis Based on Achievement of Early, Intermediate, or Late Responses During Index Studies. Rheumatol Ther. 2024 Jun;11(3):583-597. doi: 10.1007/s40744-024-00656-3. Epub 2024 Mar 15.
Baraliakos X, Szumski A, Koenig AS, Jones H. The role of C-reactive protein as a predictor of treatment response in patients with ankylosing spondylitis. Semin Arthritis Rheum. 2019 Jun;48(6):997-1004. doi: 10.1016/j.semarthrit.2018.10.019. Epub 2018 Nov 2.
Braun J, Pavelka K, Ramos-Remus C, Dimic A, Vlahos B, Freundlich B, Koenig AS. Clinical efficacy of etanercept versus sulfasalazine in ankylosing spondylitis subjects with peripheral joint involvement. J Rheumatol. 2012 Apr;39(4):836-40. doi: 10.3899/jrheum.110885. Epub 2012 Feb 15.
Braun J, van der Horst-Bruinsma IE, Huang F, Burgos-Vargas R, Vlahos B, Koenig AS, Freundlich B. Clinical efficacy and safety of etanercept versus sulfasalazine in patients with ankylosing spondylitis: a randomized, double-blind trial. Arthritis Rheum. 2011 Jun;63(6):1543-51. doi: 10.1002/art.30223.
Other Identifiers
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0881A3-402
Identifier Type: -
Identifier Source: org_study_id