A Study of Infliximab (Remicade) in Patients With Ankylosing Spondylitis.

A Randomized, Double-blind Trial of the Efficacy of REMICADE (Infliximab) Compared With Placebo in Subjects With Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug Therapy

A study of the safety and efficacy of Infliximab (Remicade) versus placebo in subjects with Ankylosing Spondylitis

This is a clinical research study that will determine if there is a reduction in the signs and symptoms (such as back pain and stiffness) of patients with ankylosing spondylitis with infliximab therapy. This study will also study the safety of infliximab in patients with ankylosing spondylitis. The effect of infliximab on physical function, damage to joints and the quality of life in patients with ankylosing spondylitis will also be studied. Subjects received infusions of either placebo at weeks 0, 2, 6, 12, 18 and 5 mg/kg infliximab at weeks 24, 26, 30 and every 6 weeks through week 96, or 5 mg/kg infliximab at weeks 1, 2, 6, 12, 18 and every 6 weeks through week 96

Inclusion Criteria:

• Have had a diagnosis of definite Akylosing Spondylitis for at least 3 months prior to screening
• Have active disease with spinal pain
• receiving or intolerant to standard anti-inflammatory agents

Exclusion Criteria:

• Have Rheumatoid Arthritis, systemic lupus erythematosus, or other inflammatory rheumatic disease
• Have a documented history of fibromyalgia
• Have total ankylosis