The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
566
50 mg
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.
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.
Time frame: 16 weeks
Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline
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).
Time frame: Baseline and 16 Weeks
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Heidelberg West, Victoria, Australia
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Shenton Park, Western Australia, Australia
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Innsbruck, Austria
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Klagenfurt, Austria
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Linz, Austria
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Beijing, China
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Shanghai, China
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Ostrava, Czechia
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Prague, Czechia
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Frederiksberg, Denmark
...and 73 more locations