Summary

for people ages 18-45 (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

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.

Official Title

A Multicenter, Open-label (Part A) Followed by a Randomized, Double-blind, Parallel-group, Placebo Controlled Study (Part B) to Evaluate Maintenance of Remission in Subjects With Active Axial Spondyloarthritis (axSpA) Receiving Either Certolizumab Pegol 200 mg Q2W or 200 mg Q4W as Compared to Placebo

Keywords

Axial SpondyloarthrithisAnkylosing SpondylitisAxial SpondyloarthritisaxSpAAnti TNF-alphaCertolizumab PegolRemissionSpondylarthropathiesArthritisSpinal DiseasesImmunosuppressive AgentsSpondylitisSpondylitis, AnkylosingOpen-label Certolizumab PegolDouble-blind Certolizumab Pegol 200 mg Q2WDouble-blind Certolizumab Pegol 200 mg Q4WCZP 200 mg Q4W to CZP 200 mg Q2W escapeCZP 200 mg Q2W to CZP 200 mg Q2W escape

Eligibility

You can join if…

Open to people ages 18-45

  • 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)

You CAN'T join if...

  • 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

Locations

  • As0005 2310
    San FranciscoCalifornia94143United States
  • As0005 2305
    UplandCalifornia91786United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
UCB BIOSCIENCES GmbH
ID
NCT02505542
Phase
Phase 3
Study Type
Interventional
Last Updated