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

Description

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.

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

Keywords

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

Eligibility

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

Locations

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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
UCB BIOSCIENCES GmbH
ID
NCT02552212
Phase
Phase 3
Lead Scientist
Lianne Gensler
Study Type
Interventional
Last Updated
May 1, 2017