RecruitingPhase 3NCT03728478

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

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


Sponsor

Istituto Giannina Gaslini

Enrollment

260 participants

Start Date

May 29, 2019

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying the best order of treatment steps — starting with stronger medications first versus starting with milder ones — for children newly diagnosed with a form of juvenile arthritis (JIA). **You may be eligible if...** - Your child has been newly diagnosed with juvenile idiopathic arthritis (specifically the oligoarthritis or rheumatoid factor negative polyarthritis type) - Your child has not yet been treated with disease-modifying drugs (DMARDs) or biologics (only one NSAID pain reliever is allowed) - Your child's arthritis symptoms started no more than 6 months ago - Your child's joints are currently actively inflamed **You may NOT be eligible if...** - Your child has already received disease-modifying or biologic medications - Your child's arthritis started more than 6 months before enrollment - Your child has a different type of juvenile arthritis not covered by this study - Your child has had steroid injections into joints before enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEtanercept

Patients will receive etanercept subcutaneously at a dose of 0.8 mg/kg weekly (up to a maximum dose of 50 mg weekly).

DRUGMethotrexate

Methotrexate will be administered subcutaneously, in a single weekly dose of 15 mg/m2 (max 20 mg).

DRUGIntra-articular corticosteroid injections

Triamcinolone hexacetonide and methylprednisolone acetate doses depend on the affected joint.


Locations(1)

IRCCS Istituto Giannina Gaslini

Genova, GE, Italy

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NCT03728478