Ultrasonography in Juvenile Idiopathic Arthritis

March 21, 2012 updated by: University of Aarhus

Changes in Joint-Cartilage as a Measure of Outcome in Juvenile Idiopathic Arthritis - Assessed by Ultrasonography and Biomarkers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Midt
      • Aarhus, Region Midt, Denmark, 8200
        • Pediatric research dept, Aarhus Universityhospital, Skejby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children diagnosed with Juvenile Idiopathic Arthritis, followed in dept of pediatric rheumatology, Aarhus University Hospital, Skejby

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

January 7, 2011

First Submitted That Met QC Criteria

February 23, 2011

First Posted (Estimate)

February 25, 2011

Study Record Updates

Last Update Posted (Estimate)

March 22, 2012

Last Update Submitted That Met QC Criteria

March 21, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10439 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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