Comparison of STep-up and step-down therapeutic strategies in childhood ARthritiS - the STARS trial

IRCCS Istituto Giannina Gaslini0 个研究点目标入组 260 人开始时间: 2018年10月11日最近更新: 2022年3月2日

试验速览

暂无简介。

•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

•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

发起方

IRCCS Istituto Giannina Gaslini