To collect demographic, clinical, therapeutic, microbiotic and imaging data in patients with JIA, to build a repository, to find novel biomarkers and to construct computerized models to predict the prognosis in children with JIA af the time of…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The development of damage (intra-articular or extra-articular) according to the
validated juvenile arthritis damage index (JADI).
Secondary outcome
Disease remission according to Wallace criteria, the juvenile arthritis
disease activity score (JADAS), functional ability (childhood health assessment
questionnaire [CHAQ] score), disease activity according to the American College
of Rheumatology (ACR) pediatric criteria. The development of radiological
damage in children with ankle involvement. The number of flares.
Background summary
Juvenile Idiopathic Arthritis (JIA) is the most common rheumatologic disorder
in children. It is characterized by arthritis of unknown etiology, manifesting
itself before 16 years of age and lasting at least 6 weeks. JIA is a
heterogeneous disorder, which is being divided into a number of subtypes. The
prognosis of JIA is highly variable, not only among subtypes, but also among
patients with the same subtype. At present, it is impossible to accurately
predict the prognosis in an individual patient.
Study objective
To collect demographic, clinical, therapeutic, microbiotic and imaging data in
patients with JIA, to build a repository, to find novel biomarkers and to
construct computerized models to predict the prognosis in children with JIA af
the time of diagnosis.
Study design
A prospective, observational cohort study.
Study burden and risks
The risk is estimated to be low: the procedures performed during the study are
part of the standard of care, which means that they are also applied to
children with juvenile idiopathic arthritis who do not participate in this
study.
The burden is estimated to be low. There is no psychological burden, no
unfavorable, traumatic results (because no tests for conditions or diseases
will be performed). The only investment for participants will be the additional
time they will have to spend in the hospital during visits.
Piazza Sant'Onofrio 4
Roma 00165
IT
Piazza Sant'Onofrio 4
Roma 00165
IT
Listed location countries
Age
Inclusion criteria
Children and adolescents with JIA according to ILAR criteria and disease duration < 6 months.
Parents or legal guardian (and the subject when age is appropriate) must be willing to sign the consent/assent forms.
Age-matched healthy subjects willing to collect a stool sample.
Exclusion criteria
None
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 | NL46068.041.13 |