Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

Inclusion Criteria:

- Documented diagnosis of adult-onset axial Spondyloarthritis (SpA) of at least 3
months' duration as defined by the specified Assessment of Spondyloarthritis
International Society (ASAS) criteria

- Active disease as defined by:

- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4

- Back pain ≥ 4 on a 0 to 10 Neurobehavioral Rating Scale (NRS) (from BASDAI item
2)

- C-Reactive Protein (CRP) > ULN (Upper Limit of Normal) and/or current evidence
(ie, within the last 3 months from Screening) for Sacroiliitis on Magnetic
Resonance Imaging (MRI) as defined by Assessment of Spondyloarthritis
International Society (ASAS) criteria

- Intolerance to or inadequate response to at least 1 Nonsteroidal Anti-Inflammatory
Drug (NSAID)

Exclusion Criteria:

- Presence of total Spinal Ankylosis ("bamboo spine")

- Diagnosis of any other Inflammatory Arthritis

- Prior treatment with any experimental biological agents for treatment of Axial
Spondyloarthritis (SpA)

- Exposure to more than 1 TNF-antagonist or to more than 2 previous biological agents
for Axial Spondyloarthritis (SpA)

- History of or current chronic or recurrent infections

- High risk of infection

- Recent live vaccination

- Concurrent malignancy or a history of malignancy

- Class III or IV congestive heart failure - New York Heart Association (NYHA)

- Demyelinating disease of the central nervous system

- Female subjects who are breastfeeding, pregnant or plan to become pregnant during the
study or within 3 months following the last dose of the investigational product

- Subjects with any other condition which, in the investigator's judgment, would make
the subject unsuitable for inclusion in the study