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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
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Scientific title
A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis
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Secondary ID [1]
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0881A3-402
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ankylosing Spondylitis
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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0
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)
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Assessment method [1]
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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.
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Timepoint [1]
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16 weeks
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Secondary outcome [1]
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Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline
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Assessment method [1]
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ASQoL is a questionnaire to assess disease specific quality of life. It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS). Each statement is answered by the patients as a "Yes" (scored as 1) or "No" (scored as 0). All item scores are summed to give a total score. Scores can range from 0 (good QoL) to 18 (poor QoL).
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Timepoint [1]
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Baseline and 16 Weeks
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Eligibility
Key inclusion criteria
* Clinical diagnosis of ankylosing spondylitis
* Active ankylosing spondylitis
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Complete ankylosis of spine
* Previous treatment with etanercept
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2008
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Sample size
Target
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Accrual to date
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Final
566
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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- Heidelberg West
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Recruitment hospital [2]
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- Shenton Park
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Recruitment postcode(s) [1]
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3081 - Heidelberg West
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Recruitment postcode(s) [2]
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6000 - Shenton Park
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Recruitment outside Australia
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Austria
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Innsbruck
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Austria
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Klagenfurt
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Austria
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Linz
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China
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Beijing
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China
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Shanghai
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Ostrava
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Czech Republic
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Praha
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Frederiksberg
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Kolding
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Odense
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Vejle
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Helsinki
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Tampere
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Amiens
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Nantes
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Orleans
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France
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Pierre Mendès
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Toulouse
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Solna
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Newcastle Upon Tyne
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United Kingdom
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Upper Borough Walls
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Wyeth is now a wholly owned subsidiary of Pfizer
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.
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Trial website
https://clinicaltrials.gov/study/NCT00247962
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Medical Monitor
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Address
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Wyeth is now a wholly owned subsidiary of Pfizer
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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
Download to PDF