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Ultrasonography in Juvenile Idiopathic Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01304420
First Posted: February 25, 2011
Last Update Posted: March 22, 2012
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.
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
  Purpose
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 Intervention Phase
Juvenile Idiopathic Arthritis, Oligoarthritis Polyarticular Juvenile Rheumatoid Arthritis Systemic Juvenile Idiopathic Arthritis Device: Ultrasonography Early Phase 1

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 95
Study Start Date: October 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Ultrasonography
    Scanning 5 joints bilaterally with an ultrasound scanner
    Other Name: Hitachi EUB-7500
  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01304420


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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01304420     History of Changes
Other Study ID Numbers: 10439
First Submitted: January 7, 2011
First Posted: February 25, 2011
Last Update Posted: March 22, 2012
Last Verified: March 2012

Keywords provided by University of Aarhus:
Juvenile idiopathic arthritis
Ultrasonography
Cartilage
Cartilage biomarkers
Bone biomarkers

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases