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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
State/province [16] 0 0
Bordeaux
Country [17] 0 0
France
State/province [17] 0 0
Boulogne Billancourt
Country [18] 0 0
France
State/province [18] 0 0
Creteil
Country [19] 0 0
France
State/province [19] 0 0
Marseille
Country [20] 0 0
France
State/province [20] 0 0
Nantes
Country [21] 0 0
France
State/province [21] 0 0
Orleans
Country [22] 0 0
France
State/province [22] 0 0
Pierre Mendès
Country [23] 0 0
France
State/province [23] 0 0
Toulouse
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Erlangen
Country [26] 0 0
Germany
State/province [26] 0 0
Gommern
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Germany
State/province [28] 0 0
Herne
Country [29] 0 0
Germany
State/province [29] 0 0
Heubnerweg
Country [30] 0 0
Germany
State/province [30] 0 0
Hildesheim
Country [31] 0 0
Germany
State/province [31] 0 0
Muenchen
Country [32] 0 0
Germany
State/province [32] 0 0
Pirna
Country [33] 0 0
Germany
State/province [33] 0 0
Ratingen
Country [34] 0 0
Germany
State/province [34] 0 0
Wiesbaden
Country [35] 0 0
Hungary
State/province [35] 0 0
Debrecen
Country [36] 0 0
Hungary
State/province [36] 0 0
Gyor
Country [37] 0 0
Hungary
State/province [37] 0 0
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
State/province [41] 0 0
Dublin
Country [42] 0 0
Italy
State/province [42] 0 0
Benevento
Country [43] 0 0
Italy
State/province [43] 0 0
Bergamo
Country [44] 0 0
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
Country [50] 0 0
Netherlands
State/province [50] 0 0
Amsterdam
Country [51] 0 0
Netherlands
State/province [51] 0 0
Groningen
Country [52] 0 0
Netherlands
State/province [52] 0 0
Leeuwarden
Country [53] 0 0
Netherlands
State/province [53] 0 0
Maastricht
Country [54] 0 0
Netherlands
State/province [54] 0 0
Nijmegen
Country [55] 0 0
Poland
State/province [55] 0 0
Lodz
Country [56] 0 0
Poland
State/province [56] 0 0
Ustron Zawodzie
Country [57] 0 0
Poland
State/province [57] 0 0
Warszawa
Country [58] 0 0
Poland
State/province [58] 0 0
Wroclaw
Country [59] 0 0
Qatar
State/province [59] 0 0
Doha
Country [60] 0 0
Saudi Arabia
State/province [60] 0 0
Riyadh
Country [61] 0 0
Spain
State/province [61] 0 0
Barcelona
Country [62] 0 0
Spain
State/province [62] 0 0
Asturias
Country [63] 0 0
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
Country [66] 0 0
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
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Glasgow
Country [74] 0 0
United Kingdom
State/province [74] 0 0
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
The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the
treatment of Ankylosing Spondylitis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00247962
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