About this trial
Biologic therapies made clinical remission an achievable goal for most juvenile idiopathic arthritis (JIA) patients. Nevertheless, antirheumatic drugs have side effects and are costly. Currently, no guidelines exist for withdrawing drugs in JIA patients with clinical inactive disease (CID). Relapses following the withdrawal of antirheumatic drugs are common. To establish an optimal timeline for treatment discontinuation is a major unmet need in pediatric rheumatology.
It is hypothesized that biomarkers-guided early withdrawal of antirheumatic drugs in patients achieving clinical, imaging and biological remission is safe and more effective compared to the standard practice of maintenance of stable treatment over 12 months.
Eligibility criteria
Qualifiers
- Children with a diagnosis of JIA according to the ILAR classification criteria
JIA patients who satisfy criteria for inactive disease for a minimum of 6 continuous months while still taking medication.
Patients who have been treated with cs/b/bs/ts DMARDs according to the label indication
Ability to comply with the entire study procedures, ability to communicate meaningfully with the investigational staff, competence to give written informed consent; to be applied to the parents and/or patients, as appropriate
Disqualifiers
- Patients with systemic JIA according to ILAR criteria
Patients with undifferentiated arthritis according to ILAR criteria
Patients with severe disease-related ocular damage and who need systemic treatment for uveitis
Patients who received glucocorticoid treatment 3 months prior to baseline visit
Trial design
Treatments tested in this trial
- Treatment medication withdrawal strategy