- Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
- Active AS, defined by average of visual analog scale (VAS) of ≥ 30 for duration and
intensity of morning stiffness and at least 2 of the following: VAS for patient global
assessment ≥ 30; average of VAS for nocturnal and total pain ≥ 30; BASFI ≥ 30 (all
scores on a scale of 0 to 100).
- Complete ankylosis (fusion) of spine.
- Previous treatment with etanercept, antibody to Tumor Necrosis Factor ? (TNF?), or
other TNF? inhibitors or other biologic agents.
- Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine,
sulphasalazine, and methotrexate within 4 weeks of baseline. Subjects treated with
hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during
this study but doses must be held stable for 4 weeks before baseline examination and
for the duration of the study.
- Receipt of multiple nonsteroidal anti-inflammatory drugs (NSAIDs) at baseline.
- Dose of NSAID changed within 2 weeks of baseline evaluation.
- Dose of prednisone >10 mg/day (or equivalent) or changed within 2 weeks of baseline
evaluation.