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Study of Adalimumab in Subjects With Axial Spondyloarthritis

 
Study IDNCT00939003
StatusRecruiting
Phase3
SourceClinicalTrials.gov
StartedJul 1 2009
Last UpdatedNov 23 2009
Estimated CompletionNov 23 2009
  
About this clinical study

Summary

This study will study how well adalimumab works in the short and long term in people with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or psoriatic arthritis.

Condition / Disease

Axial Spondyloarthritis

Therapy

Adalimumab
Placebo
Open-label Adalimumab

Study Outcomes

  • ASAS40 response (ASAS: Assessment of SpondyloArthritis International Society)
  • Adverse Events  
  • Blood and Urine Values Assessed by Central Laboratory  
  • ASAS20 response
  • ASAS partial remission
  • ASAS 5/6
  • BASDAI 50

Sponsors

Primary SponsorAbbott
 

Enrollment

Overview

Gendermale, female
 
Target Enrollment194
 
Recruiting Healthy VolunteersNo

Locations

The Center for Rheumatology and Bone ResearchWheatonMD10 mi

Criteria


Inclusion Criteria:

  • Adults with poor response to at least one NSAID
  • Chronic back pain with onset < 45 years of age
  • MRI indicating active sacroiliitis or positive HLA-B27 blood test in addition to meeting spondyloarthritis clinical criteria
  • Negative PPD test and Chest X-Ray performed at the Baseline Visit must be negative.
  • Ability to administer subcutaneous injections
  • General good health otherwise

    • Exclusion Criteria:

  • Prior anti-TNF therapy
  • Psoriasis
  • Fulfillment of modified New York criteria for Ankylosing Spondylitis
  • Recent infection requiring treatment
  • Significant medical events or conditions that may put patients at risk for participation
  • Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study
  • History of cancer, except successfully treated skin cancer
  • Recent history of drug or alcohol abuse

    • Contact

    Overall Contact

    John Dort -

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