Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS

Launched by UCB BIOSCIENCES GMBH · Sep 15, 2015

Keywords

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Eligibility criteria

• Inclusion Criteria:
• • At least 18 years old at the start of Screening Visit
• • A documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA
• • Subjects must have had back pain for at least 12 months before Screening
• • No sacroiliitis defined by Modified New York (mNY) criteria on sacroiliac (SI) x-rays
• • Active disease at Screening as defined by
• • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>= 4
• • Spinal pain \>= 4 on a 0 to 10 Numerical Rating Scale (NRS)
• • Inadequate response to, have a contraindication to, or have been intolerant to at least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
• Exclusion Criteria:
• • Diagnosis of AS or any other Inflammatory Arthritis
• • Prior treatment with any experimental biological agents for treatment of Axial SpondyloArthritis (SpA)
• • Exposure to more than 1 tumor necrosis factor (TNF)-antagonist or primary failure to TNF antagonist therapy
• • History of or current chronic or recurrent infections
• • Subjects with known Tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent Tuberculosis (LTB)
• • 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