An observational study in Juvenile Idiopathic Arthritis, sponsored by Istituto Giannina Gaslini. Status unknown at 1 site in Italy. Open to participants aged 6 Months to 30 Years. Per ClinicalTrials.gov, last updated 2018-03-05.
Sponsored by Istituto Giannina Gaslini · Observational
BACKGROUND: Juvenile idiopathic arthritis (JIA) is the most common chronic paediatric rheumatic disease (PRD) and an important cause of short and long-term disability. Although none of the available drugs for JIA has a curative potential, prognosis has greatly improved as a result of substantial progress in disease management. The therapeutic treatment of children with JIA encompasses the use of NSAIDs and intra-articular steroid injections. In those patients not responding to NSAIDs, methotrexate (MTX) has become the disease modifying anti-rheumatic drug (DMARD) of first choice worldwide. For children not responding to MTX, biologic agents recently have become treatment options.
PATIENTS AND METHODS: 3-10 year observation study related to children with JIA undergoing treatment with MTX or biologic agents with the following objectives:
The overall hypothesis to be tested is:
The overall aims are to establish the long term safety of biologic agents and MTX, and their relative effectiveness in children with JIA who need treatment with second line agents.
Study Design This is a 3-10 year, international, multicentre, observational, safety and efficacy (response, joint erosion, damage, and treatment adherence) study aimed at collecting prospective safety, tolerability, efficacy, and treatment adherence information on JIA subjects exposed to any biologic agents and MTX, according to local standard of practice.
This is a non-interventional study, where the medicinal products are prescribed as per the investigator's decision. The assignment of the subject to a particular therapeutic strategy is not decided in advance by the study protocol, but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the subject in the study. No additional diagnostic or monitoring procedures shall be applied to the subjects and epidemiological methods will be used for the analysis of collected data.
Duration and treatment will be as per investigator's decision. The nature and frequency of subjects' visits to the investigator's site will be determined only by the investigator, according to his/her judgment on the basis of the clinical evolution of the subject.
The duration of the study is expected to be at least 3 years from initiation of the first site and may be continued beyond if adequate funding is be available.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's planned enrollment of 9,000 is above the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Istituto Giannina Gaslini is the lead sponsor of 32 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male and female JIA patients selected among the PRINTO centres as part of the routine standard of care
Exclusion Criteria:
This group mainly refer to children with polyarticular course JIA treated with methotrexate ± biologics,
JIA treated with a combination of biologic and MTX (including any other add on therapy e.g. cyclosporine, leflunomide etc). This group mainly refer to children with polyarticular course JIA treated with MTX ± biologics
This group refers to children with mostly oligoarticular persistent course who are usually NOT treated with second line agents and have a more benign course.
Safety in patients with JIA on biologics/MTX from 3 to 10 years from drug initiation
To compare the long term incidence rates of emergent moderate, severe adverse events (AEs) and serious A (SAE) observed in paediatric subjects with JIA. This will include but not be limited to, malignancies, opportunistic infections, autoimmune events, cardiovascular events, central nervous system involvement (e.g. optic neuritis, demyelinating disease), infertility, gastrointestinal bleeding, macrophage activation syndrome (MAS).
Time frame: 3-10 years
Long-term efficacy in patients with JIA on biologics/MTX from 3 to 10 years from drug initiation
To assess the long-term efficacy (magnitude of response, prevention or slowing of joint erosion and damage, and treatment adherence) of biologic agents and MTX for the treatment of children and adolescents with different categories of JIA.
Time frame: 3-10 years
Predictors of safety from 3 to 10 years from drug initiation
Identify predictors of safety (clinical or experimental, magnitude of response, remission)
Time frame: 3-10 years
Risk factor from 3 to 10 years from drug initiation
Assess potential risk factors (e.g. concomitant medications or diseases, medical history etc), which may modify the safety profile of biologic agents and MTX;
Time frame: 3-10 years
Number of children in treatment with biologics from 3 to 10 years from drug initiation
To assess the number of children in which a biologic agent is added to the treatment
Time frame: 3-10 years
Wrist joint erosion from 3 to 10 years from drug initiation
Evaluate the progression of wrist joint erosion over time and abnormal growth/maturation in JIA subjects presenting a wrist involvement
Time frame: 3-10 years
Assess the reasons for stopping drug treatment from 3 to 10 years from drug initiation
• To assess the reasons for stopping drug treatment
Time frame: 3-10 years
Efficacy from 3 to 10 years from drug initiation
• To evaluate efficacy in terms, in the different JIA categories, of individual JIA core set variables, and the ACR Paediatric 30, 50, 70, 90, 100 criteria for improvement, and the achievement of clinical remission on and off medication as well as the occurrence of disease flare during biologic agents and MTX treatment course and after drug discontinuation, and the attainment of a status of minimal disease actvity (MDA)
Time frame: 3-10 years
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Istituto Giannina Gaslini