Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects 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 objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1 disease-modifying antirheumatic drug (DMARD).

Inclusion Criteria:

• Subjects must be >= 18 years of age
• meet Modified NY Criteria definition of ankylosing spondylitis (AS)
• have diagnosis of active AS based on protocol specified criteria
• inadequate response or intolerance to >= 1 nonsteroidal antiinflammatory drug (NSAID)
• be able and willing to learn to self-administer subcutaneous (SC) injections

Exclusion Criteria:

• Active tuberculosis, listeriosis,or hepatitis B, or any history of hepatitis C
• History of demyelinating disease, multiple sclerosis, cancer, or lymphoproliferative disease
• Previous anti-tumor necrosis factor therapy
• Treatment with disease-modifying antirheumatic drugs (DMARDs - other than methotrexate, hydroxychloroquine, and sulfasalazine)
• Treatment with intra-articular corticosteroid joint injections within 4 weeks of study dosing
• Biologic or investigational therapy within 6 weeks of study dosing
• Treatment with intravenous (IV) antibiotics within 30 days of study dosing
• Treatment with oral antibiotics within 14 days of study dosing