Toward Personalized Medicine to Guide Drug Withdrawal in Children with Juvenile Idiopathic Arthritis in Clinical Remission

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-18
SponsorIstituto Giannina Gaslini

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

Treatment groups

166 Participants
are divided into 2 treatment groups

Sponsors and collaborators