Clinical trial NCT00247962: Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis
Official title: A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis (AS)
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-11-02
Enrollment: 566
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ankylosing spondylitis
* Active ankylosing spondylitis

Exclusion Criteria:

* Complete ankylosis of spine
* Previous treatment with etanercept

Primary outcomes:
measure: Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)
timeFrame: 16 weeks
Secondary outcomes:
measure: Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline
timeFrame: Baseline and 16 Weeks
Other outcomes:
Locations:
city: Heidelberg West
country: Australia
state: Victoria
city: Shenton Park
country: Australia
state: Western Australia
city: Innsbruck
country: Austria
city: Klagenfurt
country: Austria
city: Linz
country: Austria
city: Beijing
country: China
city: Shanghai
country: China
city: Ostrava
country: Czech Republic
city: Praha
country: Czech Republic
city: Frederiksberg
country: Denmark
city: Kolding
country: Denmark
city: Odense
country: Denmark
city: Vejle
country: Denmark
city: Helsinki
country: Finland
city: Kuopio
country: Finland
city: Tampere
country: Finland
city: Amiens
country: France
city: Bordeaux
country: France
city: Boulogne Billancourt
country: France
city: Creteil
country: France
city: Marseille
country: France
city: Nantes
country: France
city: Orleans
country: France
city: Pierre MendÃ¨s
country: France
city: Toulouse
country: France
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Erlangen
country: Germany
city: Gommern
country: Germany
city: Hamburg
country: Germany
city: Herne
country: Germany
city: Heubnerweg
country: Germany
city: Hildesheim
country: Germany
city: Muenchen
country: Germany
city: Pirna
country: Germany
city: Ratingen
country: Germany
city: Wiesbaden
country: Germany
city: Wiesbaden
country: Germany
city: Debrecen
country: Hungary
city: Gyor
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Wilton
country: Ireland
state: Cork
city: Dublin
country: Ireland
city: Benevento
country: Italy
city: Bergamo
country: Italy
city: Firenze
country: Italy
city: Monserrato
country: Italy
city: Potenza
country: Italy
city: Prato
country: Italy
city: Reggio Emilia
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Amsterdam
country: Netherlands
city: Groningen
country: Netherlands
city: Leeuwarden
country: Netherlands
city: Maastricht
country: Netherlands
city: Nijmegen
country: Netherlands
city: Lodz
country: Poland
city: Ustron Zawodzie
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Doha
country: Qatar
city: Riyadh
country: Saudi Arabia
city: Granollers
country: Spain
state: Barcelona
city: Asturias
country: Spain
city: Barcelona
country: Spain
city: Cordoba
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Porto
country: Spain
city: Tenerife
country: Spain
city: Ostra kyrkogardsgatan
country: Sweden
city: Solna
country: Sweden
city: Upton
country: United Kingdom
state: Wirral
city: Basingstoke
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Cannock
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Upper Borough Walls
country: United Kingdom
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Poland, WPWZMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Italy, descresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Hungary, WPBUMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Czech Republic, WPPGCLI@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Australia, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Germany, medinfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Austria, WPVIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Spain, infomed@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Netherlands, trials-NL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Denmark, medinfonord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Finland, MedInfoNord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Sweden, MedInfoNord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For UK/Great Britian, ukmedinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Ireland, ukmedinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For France, infomedfrance@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For China, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.