CAN CAN-DU: Canada-Netherlands Personalized Medicine Network in Childhood Arthritis and Rheumatic Disease
- Conditions
- JIAjuvenile idiopathic arthritis10003816
- Registration Number
- NL-OMON55655
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1400
For cohorts 1,2 and 3:
• <= 18 years at time of inclusion
Cohort 1 - Biologic Basis of JIA:
Active objective arthritis suspected to be JIA
- Treatment naïve
• No systemic corticosteroids in the past 4 weeks.
• No intra-articular corticosteroid injections in the past 4 weeks.
• allowed to have received NSAIDS within 6 months of diagnosis
Cohort 2 - Start Biologics
- JIA diagnosis as per ILAR criteria (all subtypes)
- Active arthritis.
For sJIA, active disease not necessarily with arthritis.
- Time of start, restart or switch biologic therapy:
e.g. failure, insufficient/partial response or intolerance to
conventional DMARDs
Cohort 3 - Stop Biologics:
* JIA diagnosis as per ILAR criteria (all subtypes)
* Inactive disease discontinuing/tapering biologics for inactive disease
Cohort 4 - Extreme Phenotypes
* Unexplained systemic inflammation with arthritis/arthralgia as a part of
manifestations, or;
* High suspicion of genetic contribution, or;
* Severely affected patients with difficult to control disease (ie failure of
multiple classes of biologics)
- * 1 or 2 parents or siblings with a diagnosis of JIA or other arthritis
related disease.
Cohort 1 - Biologic Basis of JIA:
* Arthritis explained by any other cause
* Joint injections as previous treatment
Cohort 2 - Start Biologics:
* Arthritis explained by any other cause
* Start on biologics as an indication for uveitis only
Cohort 3 - : Stop Biologics
* Tapering scheme > 12 months to complete biologics stop
* Continuing conventional DMARDs beyond the stop of biologics
Cohort 4 - Extreme phenotypes
*Arthritis explained by another diagnosis
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>This is a non-interventional, observational cohort study, in which we aim to<br /><br>standardize the assessment of disease activity in all JIA patients at baseline<br /><br>visit, T = 6 months and T= 12 months after start of disease, start of<br /><br>biological therapy and stop of biological therapy. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- To develop a disease classification system that categorizes children with<br /><br>arthritis based on their biology and clinical data.<br /><br>- To develop a predictive tool for treatment response to 1st (or subsequent)<br /><br>biological<br /><br>- To develop a predictive tool for successful stop of biological therapy.<br /><br>- To determine disease activity at T= 2 and T =5 years after diagnosis<br /><br>- To determine treatment response at T=2 and 5 year after start of biological<br /><br>therapy<br /><br>- To register severe adverse events in our cohort in the next 5 years.<br /><br>- To assess the current socioeconomic impact of this chronic disease in<br /><br>families with an affected child with JIA. </p><br>