STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-17
SponsorIstituto Giannina Gaslini
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).
Eligibility criteria
Qualifiers
None
Disqualifiers
Active TB or a history of incompletely treated TB
PPD or QuantiFERON-TB positive patients (with no active disease) unless it is documented by a specialist that the patient has been adequately treated for TB and can start treatment with a biologic agent, based on the medical judgment of the study investigator and / or an infectious disease specialist.
Suspected extrapulmonary TB infection
Patients at high risk of contracting TB, such as close contact with individual with active or latent TB
Trial design
Treatments tested in this trial
- Etanercept
- Methotrexate
- Intra-articular corticosteroid injections
Treatment groups
260 Participants
are divided into 2 treatment groupsSponsors and collaborators
Istituto Giannina Gaslini
Lead sponsor
Agenzia Italiana del Farmaco
Collaborator
Compagnia di San Paolo
Collaborator
Pfizer
Collaborator
Source ClinicalTrials.gov