NCT03728478

STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS

Comparison of STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Istituto Giannina Gaslini · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare the effectiveness of a conventional therapeutic regimen, based on treatment escalation (step-up strategy) and driven by the treat-to-target approach, with that of an early aggressive intervention based on the initial start of a combination of conventional and biological DMARDs (step-down strategy).

Detailed description

Although their approach is different, both interventions are aimed to obtain a quick and robust disease control and to maintain it over time. Compelling evidence exists that in children with chronic arthritis early intensive therapy may take advantage of the so-called "window of opportunity", in which the biology of the disease can be altered to improve long-term disease outcomes, including prevention of cumulative joint damage. Recent experiences in children with systemic JIA have shown that early anti-IL-1 therapy may lead to rapid achievement of inactive disease and allow early treatment discontinuation without disease relapses in many patients. The benefits of early treatment with biologic agents in other JIA categories are less clear, but convincing evidence has been recently reported for polyarthritis.

Conditions

• Oligoarthritis, Juvenile
• Polyarthritis, Juvenile, Rheumatoid Factor Negative

Interventions

Type	Name	Description
DRUG	Etanercept	Patients will receive etanercept subcutaneously at a dose of 0.8 mg/kg weekly (up to a maximum dose of 50 mg weekly).
DRUG	Methotrexate	Methotrexate will be administered subcutaneously, in a single weekly dose of 15 mg/m2 (max 20 mg).
DRUG	Intra-articular corticosteroid injections	Triamcinolone hexacetonide and methylprednisolone acetate doses depend on the affected joint.

Timeline

• Start date: 2019-05-29
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2018-11-02
• Last updated: 2024-10-15

Locations

1 site across 1 country: Italy