Juvenile Idiopathic Arthritis, OligoarthritisNCT01304420
Ultrasonography in Juvenile Idiopathic Arthritis
An observational study of Juvenile Idiopathic Arthritis, Oligoarthritis and Polyarticular Juvenile Rheumatoid Arthritis, run by University of Aarhus at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Oligoarthritis, Polyarticular Juvenile Rheumatoid Arthritis, Systemic Juvenile Idiopathic Arthritis
- What is being tested?
- Ultrasonography
- Type of treatment
- Medical device
- How many people
- 95 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2009to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children diagnosed with Juvenile Idiopathic Arthritis, followed in dept of pediatric rheumatology, Aarhus University Hospital, Skejby
Who may be able to join
- Juvenile idiopathic arthritis: Oligoarticular, polyarticular or systemic onset type.
- Informed consent from parents
- between 5-15 years of age
Who cannot join
- Other diagnoses that involves bones or cartilage
- Intraarticular steroid injections within 1 month of the trial investigation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Pediatric research dept, Aarhus Universityhospital, Skejby
Aarhus, Region Midt, 8200
About this study
Official title: 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.
- Conditions
- Juvenile Idiopathic Arthritis, Oligoarthritis, Polyarticular Juvenile Rheumatoid Arthritis, Systemic Juvenile Idiopathic Arthritis
- Being tested
- Ultrasonography
- Keywords
- Juvenile idiopathic arthritis, Ultrasonography, Cartilage, Cartilage biomarkers, Bone biomarkers
- Medical subject headings
- Arthritis, Juvenile, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDevice
Also called Hitachi EUB-7500
Scanning 5 joints bilaterally with an ultrasound scanner
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1.5 years
Secondary outcomes (1)
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
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startOct 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic Arthritis, OligoarthritisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304420
- Sponsor's protocol ID
- 10439
- Status last verified
- Mar 2012
- First submitted
- 7 Jan 2011
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Joint-Cartilage as a Measure of Outcome in Juvenile Idiopathic Arthritis - Assessed by Ultrasonography and Biomarkers
- ClinicalTrials.gov ID
- NCT01304420
- Acronym / sponsor ID
- 10439
- Conditions
- Juvenile Idiopathic Arthritis, Oligoarthritis, Polyarticular Juvenile Rheumatoid Arthritis, Systemic Juvenile Idiopathic Arthritis
- Keywords
- Juvenile idiopathic arthritis, Ultrasonography, Cartilage, Cartilage biomarkers, Bone biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Oct 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 25 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children diagnosed with Juvenile Idiopathic Arthritis, followed in dept of pediatric rheumatology, Aarhus University Hospital, Skejby
Key inclusion criteria (3 listed)
- Juvenile idiopathic arthritis: Oligoarticular, polyarticular or systemic onset type.
- Informed consent from parents
- between 5-15 years of age
Key exclusion criteria (2 listed)
- Other diagnoses that involves bones or cartilage
- Intraarticular steroid injections within 1 month of the trial investigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasonographyAlso: Hitachi EUB-7500Scanning 5 joints bilaterally with an ultrasound scanner | Device | – |
Primary outcome
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 secondary outcome
Level of different biomarkers in serum and urine
Time frame: 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
Related trials for Juvenile Idiopathic Arthritis, Oligoarthritis
RecruitingPhase 3
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis
Not yet recruitingObservational study
Tenosynovitis in Polyarticular and Oligoarticular Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis, Tenosynovitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis, Oligoarthritis and Polyarticular Juvenile Rheumatoid Arthritis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint cartilage thickness (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2012.