Plain-English translation of NCT03728478 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing two different ways to treat newly diagnosed juvenile arthritis in children ages 2–17. One approach uses a 'step-up' strategy, starting with milder medications and increasing strength as needed. The other uses a 'step-down' strategy, starting with stronger combined medications right away and then reducing them once the disease is controlled. Both approaches aim to quickly control the disease and keep it under control over time.
Early, aggressive treatment of childhood arthritis can prevent permanent joint damage during a critical 'window of opportunity' when the disease is most responsive to treatment. Researchers want to know which strategy works better to achieve long-term disease control and whether children can stay well on fewer medications after their disease is under control.
You likely qualify if…
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If you join this trial, you will be randomly assigned to one of two treatment groups. One group will start with standard medications and increase strength if needed ('step-up'), while the other group will start with stronger combined medications and reduce them as the disease improves ('step-down'). You and your family will attend regular clinic visits where doctors will examine your joints, check your blood work, and adjust your medications based on how well the treatment is working. The goal is to find which approach helps your body fight the arthritis most effectively while using the least medication possible over time.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
Italy
Phase
Large-scale testing
Sponsor
Istituto Giannina Gaslini
Collaborators
Agenzia Italiana del Farmaco, Compagnia di San Paolo
Enrollment target
~260 participants
Started
May 2019
Primary completion
February 2025
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
2 Years – 17 Years
Last updated on clinicaltrials.gov in October 2024.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Alessandro Consolaro, MD, PhD
Istituto Giannina Gaslini
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.