for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Lianne Gensler



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.

Official Title

Phase 3, 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


Axial Spondyloarthritis Nonradiographic Axial Spondyloarthritis Nr-axSpA axSpA Ankylosing Spondylitis Anti TNF-alpha Certolizumab Pegol Non-radiographic Spondylarthropathies Arthritis Spinal Diseases Immunosuppressive Agents Spondylitis, Ankylosing Spondylarthritis Certolizumab Pegol 200 mg Q2W


You can join if…

Open to people ages 18 years and up

  • 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)

You CAN'T join if...

  • 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 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


  • As0006 143
    San Francisco California United States
  • As0006 155
    Beverly Hills California United States
  • As0006 101
    Palm Desert California United States


in progress, not accepting new patients
Start Date
Completion Date
Phase 3
Lead Scientist
Lianne Gensler
Study Type
Last Updated
September 12, 2018