Our primary goal is to evaluate the individual and interdependent value of optimized 3.0T imaging and immunological biomarkers for the evaluation of disease activity in JIA, compared to clinical examination.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The accuracy, validity, correlation, predictive value and responsiveness to
change of physical examination, imaging and biomarkers for the clinical course
in JIA patients.
Secondary outcome
The construction of a prediction model in JIA disease activity
The evaluation of high resolution, 3.0T MRI characteristics in the different
JIA subtypes
Background summary
Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease of the
joints in childhood with a prevalence between 16 and 150 per 100.000 children.
JIA encompasses different forms of arthritis with unknown etiology and
pathophysiology and is characterized by prolonged synovial inflammation that
can lead to destruction of joints, pain and loss of function. The increasing
evidence that early therapeutic intervention improves long-term outcome
highlight the need for objective and accurate measures in the assessment of
disease activity, individual response to therapy, efficacy of treatment and
longer-term outcomes in JIA.
Currently, diagnosis and disease activity assessment take place through
standard clinical measures: physical examination, blood tests and imaging
(conventional radiography and Magnetic Resonance Imaging (MRI)). None of these
are as yet considered as a gold standard. Recently promising results in JIA
have been achieved with serum biomarkers in the assessment of immune
activation. Having a potentially prognostic value in predicting flares or
prolonged remission of the disease. Analysis of these and other biomarkers - in
combination with state of the art, high resolution, 3.0 Tesla (3.0T) MRI and
standard physical examination measures - is necessary to determine the value of
each of these measures in assessing disease activity.
Study objective
Our primary goal is to evaluate the individual and interdependent value of
optimized 3.0T imaging and immunological biomarkers for the evaluation of
disease activity in JIA, compared to clinical examination.
Study design
Prospective study
Study burden and risks
In addition to current clinical care - which includes physical examination,
blood sampling, conventional radiography and MRI - a supplementary 10mL blood
will be taken (serum, genetic profiling) and is therefore minimally invasive.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Clinically suspected JIA or diagnosed with JIA.
Scheduled to undergo MRI of the affected joint.
Written informed patients (when >12 years of age) and parental consent
OR
JIA patients with clinically inactive disease for at least 6 months.
A history of clinical evident arthritis in at least 1 joint.
Scheduled to undergo MRI of knee, hand/wrist, ankle or SI joint.
Written informed patients (when >12 years of age) and parental consent.
Exclusion criteria
Age <8 and >18 years.
General contraindications for MRI (such as renal insufficiency, pregnancy and claustrophobia)
Lack of written informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52625.018.15 |