Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis

A Phase 3, Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis

The purpose of the study is to assess the safety and clinical efficacy of adalimumab in subjects with active ankylosing spondylitis

Inclusion Criteria:

• Subject was age 18 or older and in relatively good health (Investigator discretion) with a recent stable medical history.
• Subject met the definition of AS based on the Modified New York Criteria.
• Subject had an inadequate response to or intolerance to one or more NSAIDs as defined by the Investigator

Exclusion Criteria:

• Subject had previously received anti-TNF therapy.
• Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
• Female subject who is pregnant or breast-feeding or considering becoming pregnant