Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS
Condition: Axial Spondyloarthritis; Nonradiographic Axial Spondyloarthritis; Nr-axSpA
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Non-Radiographic 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 317.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Axial Spondyloarthritis; axSpA; Ankylosing Spondylitis; Anti TNF-alpha; Certolizumab Pegol; Nr-axSpA; Non-radiographic; Spondylarthropathies; Arthritis; Spinal Diseases; Immunosuppressive Agents

Summary:

      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.
    

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