Actively Recruiting
STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS
Led by Istituto Giannina Gaslini · Updated on 2024-10-15
260
Participants Needed
1
Research Sites
300 weeks
Total Duration
On this page
Sponsors
I
Istituto Giannina Gaslini
Lead Sponsor
A
Agenzia Italiana del Farmaco
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed children aged 2 to 17 years with juvenile idiopathic arthritis classified as oligoarthritis or rheumatoid factor negative polyarthritis
- Active arthritis present
- Onset of JIA symptoms no more than 6 months before enrollment
- No prior treatment with synthetic or biologic DMARDs; treatment with only one NSAID is allowed
- Female participants of child-bearing potential must have a negative pregnancy test at study start and agree to use effective contraception if sexually active
- Post-pubertal males must agree to use highly effective contraception if sexually active and have no plans to father a child during the study
- Ability to comply with study procedures and communicate with staff
- Written informed consent/assent obtained from parents and/or patients
You will not qualify if you...
- Diagnosis of systemic arthritis, RF-positive polyarthritis, psoriatic arthritis, enthesitis-related arthritis, or undifferentiated arthritis
- Need for systemic treatment for uveitis
- Active tuberculosis or history of inadequately treated tuberculosis
- Positive tuberculosis tests (PPD or QuantiFERON-TB) without documented adequate treatment
- Suspected extrapulmonary tuberculosis
- High risk of tuberculosis exposure
- Prior treatment with any synthetic or biologic DMARD
- Receipt of any live attenuated vaccine within 4 weeks before baseline or during the study
- History of malignancy or significant other illnesses
- Laboratory abnormalities including low white blood cell or neutrophil counts, low hemoglobin, abnormal platelet counts, or elevated liver enzymes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Istituto Giannina Gaslini
Genova, GE, Italy, 16147
Actively Recruiting
Research Team
A
Alessandro Consolaro, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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