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for people ages 18 years and up
at San Francisco, California and other locations
study started
estimated completion:
Principal Investigator



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

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


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) 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
  • 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, or contraindication to, or intolerant to at least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

You CAN'T join if...

  • 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


  • As0006 143 accepting new patients
    San Francisco, California, USA
  • As0006 155 accepting new patients
    Beverly Hills, California, USA
  • As0006 131 withdrawn
    Covina, California, USA
  • As0006 157 accepting new patients
    Fullerton, California, USA
  • As0006 101 accepting new patients
    Palm Desert, California, USA
  • As0006 140 withdrawn
    Tustin, California, USA


accepting new patients
Start Date
Completion Date
Phase 3
Lead Scientist
Lianne Gensler
Study Type
Last Updated
April 2017
I'm interested in this study!