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ClinicalTrial.gov Identifier : NCT00939003

Study of Adalimumab in Subjects With Axial Spondyloarthritis

    Status Completed
    Related Conditions

Enrollment Details

185 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type III phase trial.

Brief summary

Top

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

Participant Attributes :
  • Male and Female
  • Ages 18 Years and older

Canada: 4

0
Edmonton, AB
1
Quebec, QC
2
Toronto, ON
3
St. John's, NL
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Study Design

  • The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.
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    Allocation

    Randomized

  • A target outcome that the study’s protocol aims to evaluate - things like: the occurrence of a disease, a symptom, sign, or lab abnormality, among others.
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    Endpoint Classification

    Safety/Efficacy Study

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Parallel Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
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    Purpose

    Treatment

    • Adult subjects with inadequate response to >/= 1 non-steroidal anti-inflammatories (NSAIDs)
    • 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 purified protein derivative (PPD) test and Chest X-Ray performed at Baseline Visit must be Negative
    • Ability to administer subcutaneous injections
    • General good health otherwise
    • Prior anti-TNF therapy
    • Psoriasis or Psoriatic Arthritis
    • 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

More on this trial

Clinical Trials.gov