Ultrasonography in Juvenile Idiopathic Arthritis

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01304420
First received: January 7, 2011
Last updated: March 21, 2012
Last verified: March 2012
  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
Phase 0

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01304420     History of Changes
Other Study ID Numbers: 10439
Study First Received: January 7, 2011
Last Updated: March 21, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on July 29, 2014