NCT01304420

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

March 22, 2012

Status Verified

March 1, 2012

Enrollment Period

2.1 years

First QC Date

January 7, 2011

Last Update Submit

March 21, 2012

Conditions

Juvenile Idiopathic Arthritis, OligoarthritisPolyarticular Juvenile Rheumatoid ArthritisSystemic Juvenile Idiopathic Arthritis

Keywords

Juvenile idiopathic arthritisUltrasonographyCartilageCartilage biomarkersBone biomarkers

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Level of different biomarkers in serum and urine

    1.5 years

Interventions

UltrasonographyDEVICE

Scanning 5 joints bilaterally with an ultrasound scanner

Also known as: Hitachi EUB-7500

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric research dept, Aarhus Universityhospital, Skejby

Aarhus, Region Midt, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum specimens taken for rutine markers of inflammation.

MeSH Terms

Conditions

Arthritis, JuvenileArthritis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2011

First Posted

February 25, 2011

Study Start

October 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

March 22, 2012

Record last verified: 2012-03

Locations

DK(1)