Ultrasonography in Juvenile Idiopathic Arthritis

Systemic Juvenile Idiopathic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304420
• Other study ID #: 10439
• Status: Completed
• Phase: Phase 0
• First received: January 7, 2011
• Last updated: March 21, 2012
• Start date: October 2009
• Est. completion date: November 2011

Study information

• Verified date: March 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Rheumatoid
• Juvenile Idiopathic Arthritis, Oligoarthritis
• Polyarticular Juvenile Rheumatoid Arthritis
• Systemic Juvenile Idiopathic Arthritis

Intervention

Device:
• Ultrasonography
Scanning 5 joints bilaterally with an ultrasound scanner

Locations

Country	Name	City	State
Denmark	Pediatric research dept, Aarhus Universityhospital, Skejby	Aarhus	Region Midt

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Joint cartilage thickness	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	No
Secondary	Level of different biomarkers in serum and urine	Level of bone- and cartilage-degradation biomarkers in serum and urine. COMP, CTX-II, RANKL/OPG, PYD/DPD	1.5 years	No