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

Who is this study for? Child to young adult patients with Juvenile Idiopathic Arthritis
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:

• 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 according to the following ILAR categories:

• i. Oligoarthritis ii. Rheumatoid factor negative polyarthritis

• II. Active arthritis

• III. Onset of JIA symptoms no more than 6 months before randomization

• IV. Age 2 to 17 years at enrolment.

• V. Female of child-bearing potential must have a negative pregnancy test at the beginning of the trial. If sexually active, they must agree to use highly effective contraceptive measures, throughout study participation, and must have no intention of conceiving during the course of the study. Post-pubertal males must have no plans to father a child during the study and agree to use highly effective contraceptive measures if sexually active.

• VI. Ability to comply with the entire study procedures, ability to communicate meaningfully with the investigational staff, competence to give written informed consent; to be applied to the parents and/or patients, as appropriate

• VII. Duly executed, written, informed consent/assent obtained from the parents/patient.

Locations
Other Locations
Italy
IRCCS Istituto Giannina Gaslini
RECRUITING
Genova
Contact Information
Primary
Alessandro Consolaro, MD, PhD
alessandroconsolaro@gaslini.org
01056362729
Time Frame
Start Date: 2019-05-29
Estimated Completion Date: 2025-02-28
Participants
Target number of participants: 260
Treatments
No_intervention: Treatment arm 1: Step-up
JIA patients managed with a Treat-To-Target strategy (T2T)
Experimental: Treatment arm 2: Step-down
JIA patients treated with an early combined therapy
Sponsors
Collaborators: Compagnia di San Paolo, Pfizer, Agenzia Italiana del Farmaco
Leads: Istituto Giannina Gaslini

This content was sourced from clinicaltrials.gov