Treatment medication withdrawal strategy: The study aims to compare early biomarkers-guided versus conventional unguided drugs withdrawal strategy.
Study summary
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
Sex
ALL
Min age
2 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
* \- 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
* Duly executed, written, informed consent obtained from the patient's parents/legal guardian
* Female of child-bearing potential must have a negative pregnancy test at the beginning of the trial. If sexually active, they must have no intention of conceiving while on treatment with antirheumatic drugs.
Exclusion Criteria:
* \- 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
* Patients who had previously unsuccessfully attempted tapering cs/b/bs/tsDMARDs
* Patients with severe damage as per caring physician measured
* Prior or current history of other significant concomitant illness(es) that, according to the Investigator's judgment, would adversely affect the patient's participation in the study
* Any other medical condition or laboratory examination which in the opinion of the caring physician should exclude the patient from participation to the study
Primary outcome measure(s)
Effectiveness of early biomarker-guided withdrawal of antirheumatic agents — 12 months At each timepoint the following procedures will be performed: joint assessment, Physician's Global Assessment of Overall Disease Activity, JAMAR, Uveitis assessment (in ANA positive patients), Hematology, chemistry, CRP, ESR, urine analysis according to drug specific schedule and Good Clinical Practice (GCP). Drug Adverse Events will be collected (MedDRA), to measure safety and efficacy of early biomarker-guided withdrawal of antirheumatic agents in JIA patients achieving 6 months clinical inactive disease (CID) who do not have subclinical inflammation when compared to the standard practice of maintenance of stable treatment intensity over 12 months.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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