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NOT YET RECRUITING
NCT06618937
PHASE4

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

Sponsor: Istituto Giannina Gaslini

View on ClinicalTrials.gov

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.

Official title: Toward Personalized Medicine to Guide Drug Withdrawal in Children with Juvenile Idiopathic Arthritis in Clinical Remission: a Randomized Clinical Trial Comparing Early Versus Late Drug Withdrawal Combining Imaging and Multi-Omics

Key Details

Gender

All

Age Range

2 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

166

Start Date

2025-01-01

Completion Date

2029-01-01

Last Updated

2024-10-01

Healthy Volunteers

No

Interventions

OTHER

Treatment medication withdrawal strategy

The study aims to compare early biomarkers-guided versus conventional unguided drugs withdrawal strategy.

Locations (1)

Istituto Giannina Gaslini

Genoa, GE, Italy