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Ultrasonography in Juvenile Idiopathic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01304420
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : March 22, 2012
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
The purpose of this study is to analyse the usability of ultrasonography together with biomarkers in the investigation of patients diagnosed with juvenile idiopathic arthritis. The investigators hypothesize that serum and urine markers of cartilage and bone synthesis and degradation, together with ultrasound measurements of joint cartilage thickness, are useful tools in the early evaluation of JIA patients, - as diagnostic, prognostic and monitoring methods.

Condition or disease Intervention/treatment
Juvenile Idiopathic Arthritis, Oligoarthritis Polyarticular Juvenile Rheumatoid Arthritis Systemic Juvenile Idiopathic Arthritis Device: Ultrasonography

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Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Changes in Joint-Cartilage as a Measure of Outcome in Juvenile Idiopathic Arthritis - Assessed by Ultrasonography and Biomarkers
Study Start Date : October 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Intervention Details:
  • Device: Ultrasonography
    Scanning 5 joints bilaterally with an ultrasound scanner
    Other Name: Hitachi EUB-7500

Primary Outcome Measures :
  1. Joint cartilage thickness [ Time Frame: 1.5 years ]
    Joint catilage thickness measured by ultrasonography: knee, ankle, wrist, metacarpophalangeal and proximal interphalangeal joints by MRI: one knee by plain radiographs: knee, ankel and wrist

Secondary Outcome Measures :
  1. Level of different biomarkers in serum and urine [ Time Frame: 1.5 years ]
    Level of bone- and cartilage-degradation biomarkers in serum and urine. COMP, CTX-II, RANKL/OPG, PYD/DPD

Biospecimen Retention:   Samples Without DNA
Serum specimens taken for rutine markers of inflammation.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children diagnosed with Juvenile Idiopathic Arthritis, followed in dept of pediatric rheumatology, Aarhus University Hospital, Skejby

Inclusion Criteria:

  • Juvenile idiopathic arthritis: Oligoarticular, polyarticular or systemic onset type.
  • Informed consent from parents
  • between 5-15 years of age

Exclusion Criteria:

  • Other diagnoses that involves bones or cartilage
  • Intraarticular steroid injections within 1 month of the trial investigation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01304420

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Pediatric research dept, Aarhus Universityhospital, Skejby
Aarhus, Region Midt, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital

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Responsible Party: University of Aarhus Identifier: NCT01304420     History of Changes
Other Study ID Numbers: 10439
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: March 22, 2012
Last Verified: March 2012
Keywords provided by University of Aarhus:
Juvenile idiopathic arthritis
Cartilage biomarkers
Bone biomarkers
Additional relevant MeSH terms:
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Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases