Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis

A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing Spondylitis

Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.

Inclusion criteria

• Active and severe ankylosing spondylitis
• Ankylosing spondylitis refractory to standard anti-rheumatic treatment
• Between 18 and 70 years of age

Exclusion criteria

• Prior exposure to any TNF-inhibitor, including etanercept
• DMARDs (other than hydroxychloroquine, methotrexate and sulphasalazine) within 4 weeks of study drug initiation
• Dose of NSAIDs changed within two weeks of study drug initiation