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

Recruiting Phase 3 Interventional Study
Oligoarthritis, Juvenile Polyarthritis, Juvenile, Rheumatoid Factor Negative
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
260 (estimated)
Sponsor
Istituto Giannina Gaslini · Other
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria Each patient must meet all the following criteria in order to be enrolled in the trial: I. Newly-diagnosed and synthetic or biologic DMARD-naïve children (only treatment with 1 NSAID is allowed and no corticosteroid joint injections prior to randomization ) with a JIA classified…
Contacts

Alessandro Consolaro, MD, PhD

01056362729

alessandroconsolaro@gaslini.org

CONTACT