Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo
Condition: Axial Spondyloarthrithis; Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Axial Spondyloarthritis
Intervention: Certolizumab Pegol; Placebo
Intervention description: Active substance: Certolizumab Pegol
Pharmaceutical form: Prefilled syringe
Concentration: 200 mg / ml
Route of Administration: Subcutaneous injection; Active substance: Placebo
Pharmaceutical form: Prefilled syringe
Concentration: 0.9 % Saline
Route of Administration: Subcutaneous 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: 736.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Axial Spondyloarthritis; axSpA; Ankylosing Spondylitis; Anti TNF-alpha; Certolizumab Pegol; Remission; Spondylarthropathies; Arthritis; Spinal Diseases; Immunosuppressive Agents

Summary:

      Patients receive study drug for one year (Part A). If, after the initial run-in phase, a
      sustained remission is reached they will be randomly split into one of three dose groups for
      another year (Part B). The maintenance of the sustained remission will be analyzed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) with at least 3
             months' symptom duration and meet the Assessment of SpondyloArthritis International
             Society (ASAS) criteria for axSpA and symptom duration of less than 5 years prior to
             the participation of this study

          -  Active disease at Screening as defined by

               -  Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥ 2.1

               -  Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4

               -  Spinal pain > 4 on a 0 to 10 Numerical Rating Scale (NRS) (from BASDAI Item 2)

               -  for modified New York (mNY) -negative subjects only: C-reactive Protein (CRP) >
                  upper limit of normal (ULN) and/or current evidence for sacroiliitis on the
                  Screening Magnetic Resonance Imaging (MRI)

          -  Inadequate response to, or contraindication to, or intolerant to at least 2
             Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

        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 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 which, in the investigator's judgment, would make
             the subject unsuitable for inclusion in the study