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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00247962




Registration number
NCT00247962
Ethics application status
Date submitted
31/10/2005
Date registered
2/11/2005
Date last updated
8/11/2012

Titles & IDs
Public title
Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis
Scientific title
A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis
Secondary ID [1] 0 0
0881A3-402
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankylosing Spondylitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - etanercept
Treatment: Drugs - sulphasalazine (SSZ)

Experimental: A -

Active comparator: B -


Treatment: Drugs: etanercept
50 mg

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)
Timepoint [1] 0 0
16 weeks
Secondary outcome [1] 0 0
Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline
Timepoint [1] 0 0
Baseline and 16 Weeks

Eligibility
Key inclusion criteria
* Clinical diagnosis of ankylosing spondylitis
* Active ankylosing spondylitis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Complete ankylosis of spine
* Previous treatment with etanercept

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2008
Sample size
Target
Accrual to date
Final
566
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
- Heidelberg West
Recruitment hospital [2] 0 0
- Shenton Park
Recruitment postcode(s) [1] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [2] 0 0
6000 - Shenton Park
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
Country [2] 0 0
Austria
State/province [2] 0 0
Klagenfurt
Country [3] 0 0
Austria
State/province [3] 0 0
Linz
Country [4] 0 0
China
State/province [4] 0 0
Beijing
Country [5] 0 0
China
State/province [5] 0 0
Shanghai
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Ostrava
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Praha
Country [8] 0 0
Denmark
State/province [8] 0 0
Frederiksberg
Country [9] 0 0
Denmark
State/province [9] 0 0
Kolding
Country [10] 0 0
Denmark
State/province [10] 0 0
Odense
Country [11] 0 0
Denmark
State/province [11] 0 0
Vejle
Country [12] 0 0
Finland
State/province [12] 0 0
Helsinki
Country [13] 0 0
Finland
State/province [13] 0 0
Kuopio
Country [14] 0 0
Finland
State/province [14] 0 0
Tampere
Country [15] 0 0
France
State/province [15] 0 0
Amiens
Country [16] 0 0
France
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Bordeaux
Country [17] 0 0
France
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Boulogne Billancourt
Country [18] 0 0
France
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Creteil
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France
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Marseille
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France
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Nantes
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France
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Orleans
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France
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Pierre Mendès
Country [23] 0 0
France
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Toulouse
Country [24] 0 0
Germany
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Berlin
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Germany
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Erlangen
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Germany
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Gommern
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Germany
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Hamburg
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Germany
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Herne
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Germany
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Heubnerweg
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Germany
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Hildesheim
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Germany
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Muenchen
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Germany
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Pirna
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Germany
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Ratingen
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Germany
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Wiesbaden
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Hungary
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Debrecen
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Hungary
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Gyor
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Hungary
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Nyiregyhaza
Country [38] 0 0
Hungary
State/province [38] 0 0
Pecs
Country [39] 0 0
Hungary
State/province [39] 0 0
Szeged
Country [40] 0 0
Ireland
State/province [40] 0 0
Cork
Country [41] 0 0
Ireland
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Dublin
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Italy
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Benevento
Country [43] 0 0
Italy
State/province [43] 0 0
Bergamo
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Italy
State/province [44] 0 0
Firenze
Country [45] 0 0
Italy
State/province [45] 0 0
Monserrato
Country [46] 0 0
Italy
State/province [46] 0 0
Potenza
Country [47] 0 0
Italy
State/province [47] 0 0
Prato
Country [48] 0 0
Italy
State/province [48] 0 0
Reggio Emilia
Country [49] 0 0
Italy
State/province [49] 0 0
Roma
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Netherlands
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Amsterdam
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Netherlands
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Groningen
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Netherlands
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Leeuwarden
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Netherlands
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Maastricht
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Netherlands
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Nijmegen
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Poland
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Lodz
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Poland
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Ustron Zawodzie
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Poland
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Warszawa
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Poland
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Wroclaw
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Qatar
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Doha
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Saudi Arabia
State/province [60] 0 0
Riyadh
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Spain
State/province [61] 0 0
Barcelona
Country [62] 0 0
Spain
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Asturias
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Spain
State/province [63] 0 0
Cordoba
Country [64] 0 0
Spain
State/province [64] 0 0
Madrid
Country [65] 0 0
Spain
State/province [65] 0 0
Porto
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Spain
State/province [66] 0 0
Tenerife
Country [67] 0 0
Sweden
State/province [67] 0 0
Ostra kyrkogardsgatan
Country [68] 0 0
Sweden
State/province [68] 0 0
Solna
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Wirral
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Basingstoke
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Cambridge
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Cannock
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United Kingdom
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Glasgow
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United Kingdom
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Liverpool
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Newcastle Upon Tyne
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Upper Borough Walls

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Wyeth is now a wholly owned subsidiary of Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00247962