SHS_280158 MEAP CUCB 15121
Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis (axSpA) Without X-ray Evidence of Ankylosing Spondylitis (AS) and Objective Signs of Inflammation
Patients with active Axial Spondyloarthritis without x-ray evidence of Ankylosing Spondylitis and with signs of inflammation will be randomly assigned to receive certolizumab pegol (CZP) 200 mg every two weeks or placebo. The primary objective is to demonstrate the efficacy of CZP in these patients.
At least 18 years old at the start of Screening Visit.
A documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) as defined by the specified Assessment of SpondyloArthritis International Society (ASAS) criteria with at least 12 months symptom duration before screening.
No sacroiliitis defined by Modified New York (mNY) criteria on sacroiliac (SI) x-rays. Inadequate response to, or contraindication to, or intolerant to at least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs).
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 primary failure to TNF antagonist therapy.
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 that, in the investigator judgment, would make the subject unsuitable for inclusion in the study.
Philip Mease, M.D.