Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis
A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis
1 other identifier
interventional
566
17 countries
80
Brief Summary
The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2005
Typical duration for phase_4
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2005
CompletedFirst Posted
Study publicly available on registry
November 2, 2005
CompletedStudy Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
November 8, 2012
CompletedNovember 8, 2012
October 1, 2012
2.2 years
October 31, 2005
January 30, 2009
October 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an improvement ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
16 weeks
Secondary Outcomes (1)
Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline
Baseline and 16 Weeks
Study Arms (2)
A
EXPERIMENTALB
ACTIVE COMPARATORInterventions
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
You may qualify if:
- Clinical diagnosis of ankylosing spondylitis
- Active ankylosing spondylitis
You may not qualify if:
- Complete ankylosis of spine
- Previous treatment with etanercept
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (83)
Unknown Facility
Heidelberg West, Victoria, 3081, Australia
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Shenton Park, Western Australia, 6000, Australia
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Innsbruck, 6020, Austria
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Klagenfurt, A-9020, Austria
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Linz, A-4020, Austria
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Beijing, 100853, China
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Shanghai, 200001, China
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Ostrava, 722 00, Czechia
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Prague, 120 00, Czechia
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Frederiksberg, DK-2000, Denmark
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Kolding, 6000, Denmark
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Odense, 5000, Denmark
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Vejle, 7100, Denmark
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Helsinki, 00029, Finland
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Kuopio, 70211, Finland
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Tampere, 33100, Finland
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Amiens, 80054, France
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Bordeaux, 33076, France
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Boulogne-Billancourt, 92104, France
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Créteil, 94010, France
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Marseille, 13005, France
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Nantes, 44000, France
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Orléans, 45032, France
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Pierre Mendès, 76290, France
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Toulouse, 31059, France
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Berlin, 12200, Germany
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Berlin, D-10117, Germany
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Erlangen, D-91054, Germany
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Gommern, D-39245, Germany
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Hamburg, D-22081, Germany
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Herne, D-44652, Germany
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Heubnerweg, D-14059, Germany
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Hildesheim, D-31134, Germany
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München, D-80639, Germany
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Pirna, D-01796, Germany
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Ratingen, D-40882, Germany
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Wiesbaden, 65185, Germany
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Wiesbaden, D-65191, Germany
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Debrecen, 4043, Hungary
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Győr, 9025, Hungary
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Nyíregyháza, 4400, Hungary
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Pécs, 7621, Hungary
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Szeged, 6724, Hungary
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Wilton, Cork, Ireland
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Dublin, Ireland
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Benevento, 82037, Italy
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Bergamo, 24128, Italy
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Florence, 50143, Italy
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Monserrato, 09042, Italy
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Potenza, 85100, Italy
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Prato, 59100, Italy
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Reggio Emilia, 42100, Italy
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Roma, 00161, Italy
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Roma, 00189, Italy
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Amsterdam, 1081 HV, Netherlands
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Groningen, 9713GZ, Netherlands
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Leeuwarden, 8934AD, Netherlands
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Maastricht, 6229HX, Netherlands
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Nijmegen, 6522JV, Netherlands
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Lodz, 93-513, Poland
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Ustron Zawodzie, 43-450, Poland
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Warsaw, 02-637, Poland
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Wroclaw, 53-137, Poland
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Doha, 3050, Qatar
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Riyadh, 11426, Saudi Arabia
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Granollers, Barcelona, 08400, Spain
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Asturias, 33012, Spain
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Barcelona, 08003, Spain
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Córdoba, 14004, Spain
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Madrid, 28035, Spain
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Madrid, 28922, Spain
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Porto, 4200-319, Spain
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Santa Cruz de Tenerife, 38010, Spain
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Ostra Kyrkogardsgatan, 59333, Sweden
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Solna, 17176, Sweden
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Upton, Wirral, L49 5PE, United Kingdom
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Basingstoke, RG24 9NA, United Kingdom
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Cambridge, CB2 2QQ, United Kingdom
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Cannock, WS11 2XY, United Kingdom
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Glasgow, G31 2ER, United Kingdom
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Liverpool, L9 7AL, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Upper Borough Walls, BA1 1RL, United Kingdom
Related Publications (4)
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.
PMID: 38488976DERIVEDBaraliakos 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.
PMID: 30473179DERIVEDBraun 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.
PMID: 22337244DERIVEDBraun 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.
PMID: 21630245DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- U. S. Contact Center
- Organization
- Wyeth
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
- PRINCIPAL INVESTIGATOR
Trial Manager
For Poland, WPWZMED@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Italy, descresg@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Hungary, WPBUMED@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Czech Republic, WPPGCLI@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Australia, medinfo@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Germany, medinfoDEU@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Austria, WPVIMED@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Spain, infomed@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Netherlands, trials-NL@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Denmark, medinfonord@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Finland, MedInfoNord@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Sweden, MedInfoNord@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For UK/Great Britian, ukmedinfo@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Ireland, ukmedinfo@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For France, infomedfrance@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For China, medinfo@wyeth.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2005
First Posted
November 2, 2005
Study Start
December 1, 2005
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
November 8, 2012
Results First Posted
November 8, 2012
Record last verified: 2012-10