Comparison of therapeutic strategies in childhood ARthritiS

Phase 1

• Conditions: Juvenile idiopathic arthritis (JIA) is an umbrella term that encompasses a heterogeneous group of disorders characterised by prolonged synovial inflammation that may cause destructive damage to joint structures. Permanent changes may also develop in extraarticular organs, particularly the eye (as a complication of chronic anterior uveitis), or may result from side effects of medications.; MedDRA version: 20.0Level: LLTClassification code 10059177Term: Juvenile arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-001931-27-IT
• Lead Sponsor: IRCCS Istituto Giannina Gaslini

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-11
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

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, and then every 3 months. If sexually active, they must agree to use adequate contraception, 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 adequate birth control methods 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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 260
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

I.Classification in one of the following JIA categories: systemic arthritis, RF-positive polyarthritis, psoriatic arthritis, enthesitis-related arthritis, undifferentiated arthritis
II.Patients who need systemic treatment for uveitis
III.Tuberculosis related issues: patients are excluded from the study if they have:
a.Active TB or a history of incompletely treated TB
b.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.
c.Suspected extrapulmonary TB infection
d.Patients at high risk of contracting TB, such as close contact with individual with active or latent TB
IV.Previous treatment with any synthetic or biologic DMARD
V.Any live attenuated vaccine within 4 weeks prior to the baseline visit, such as varicella-zoster, oral polio, measles, mumps or rubella vaccines and throughout the study. Killed or inactive vaccine may be permitted based on the investigator’s judgment
VI.Prior or current history of malignancy or any other significant concomitant illness(es) as per the treating physician evaluation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified