Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
Condition: Spondyloarthropathies
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Spondylarthropathies
Intervention: CZP 200 mg Q2W; CZP 400 mg Q4W; Placebo
Intervention description: 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).; 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).; Matching Placebo to CZP injection.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 325.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Certolizumab Pegol; Cimzia

Summary:

      The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to
      evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects
      with active axial Spondyloarthritis (axial SpA).
    

Eligibility criteria:

        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