ETANERCEPT for Juvenile Idiopathic Arthritis

Inclusion criteria

• {"criterion_text":"-Children with a diagnosis of JIA according to the ILAR criteria, candidate to treatment with anti-TNF alpha drugs (etanercept or adalimumab) as per the approved label indication and per treating physician/family decision, classified as per ILAR criteria in: Oligoarthritis; Rheumatoid factor negative polyarthritis; Rheumatoid factor positive polyarthritis; Psoriatic arthritis; Enthesitis-related arthritis.\n-Moderate to high disease activity despite methotrexate treatment for at least 3 months.\n-Age 2 to <18 years at time of enrolment\n-For Etanercept, only patients eligible for receiving authorized biosimilar formulations according to the Summary of Product Characteristics (SmPC), i.e. with the proper weight range, will be enrolled: since etanercept biosimilar formulations are available only with fix doses (25 mg and 50 mg), only patients, with age < 18 years old at the time of enrolment, weighted >30 and < 32 kg or subjects > 62 kg could be enrolled\n-Ability to comply with the entire study procedures, ability to communicate meaningfully with the investigational staff to be applied to the parents and/or patients, as appropriate\n-Duly executed, written, informed consent obtained from the patient’s parents\n-For sexually active participants, compliance in undertaking highly effective contraception methods throughout the study"}

Exclusion criteria

• {"criterion_text":"-Children with systemic JIA according to ILAR criteria\n-Prior or current history of malignancy, including lymphoproliferative diseases, other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell, or basal cell carcinoma of the skin, within 5 years prior to the baseline visit\n-Prior or current history of other significant concomitant illness(es) that, according to the Investigator’s judgment, would adversely affect the patient’s participation in the study. These include, but are not limited to, cardiovascular, renal, neurological disorder (including demyelinating disease), active infectious diseases, endocrinological, gastrointestinal, hepatobiliary, metabolic, pulmonary (e.g. severe asthma, cystic fibrosis), nonmalignant lymphoproliferative diseases, other lymphatic disease(s), autoimmune disease, psychiatric disorders, history of inflammatory bowel disease, severe diverticulitis, or previous gastrointestinal perforation, uncontrolled diabetes mellitus, defined as glycosylated hemoglobin (HbA1c) ≥ 9% at the screening visit\n-Sepsis or risk of sepsis, active infections including chronic or local infections\n-Moderate to severe heart failure (NYHA class III/IV)\n-A history of COVID-19 infection or vaccination does not exclude participation in the trial if real-time reverse transcription polymerase chain reaction (RT-PCR) confirm the absence of viral RNA in patient specimens\n-For Etanercept, patients with a weight range different from the indications reported in the Summary of Product Characteristics of the biosimilar formulations will not be enrolled. If, during the study, the weight falls outside the indicated ranges for taking biosimilars, the subject will be withdrawn from the study\n-Hypersensitivity to the active substance or to any of the excipients\n-Ongoing treatment in the screening phase with any other second-line agents (except methotrexate) or intravenous immunoglobulin\n-Abnormalities in laboratory values: white blood cell count < 3,000/mm3, a platelet count < 50,000/mm3, levels of serum glutamic oxaloacetic transaminase/asparagine aminotransferase (SGOT/AST) or serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) above the upper limit of normal according to the local lab reference, creatinine levels above the upper limit of normal according to the local lab reference or eGFR < 60 ml/min/1.73 m2 calculated according with bedside Schwartz equation, chronic proteinuria or hematuria (2–4/4 on dipstick on 2 consecutive tests)\n-Positive serologic findings of hepatitis B or C\n-Active tuberculosis TB or a history of incompletely treated TB\n-Purified protein derivative (PPD) skin test or QuantiFERON-TB positive patients (with no active disease) are excluded from the study 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\n-Suspected extrapulmonary TB infection\n-Patients at high risk of contracting TB, such as close contact with individual with active or latent TB\n-Any live attenuated vaccine within 4 weeks prior to the baseline visit, such as varicella-zoster, oral polio, measle, mumps or rubella vaccines and throughout the study. Killed or inactive vaccine may be permitted based on the investigator’s judgment"}

Primary endpoints

• {"endpoint_text":"-Clinical remission. Efficacy of therapeutic strategies will be compared by assessing the frequency of clinical remission (CR) at 18 months (6 months after randomization for entrance in Phase B). CR is defined as the persistence of the Juvenile Arthritis Disease Activity Score (JADAS) state of inactive disease (ID) for at least 6 months. Assessment of efficacy of the switch will be determined comparing the proportion of patients in CR at 18 months in the switched vs the non switched cohort","definition_or_measurement_approach":"CR is defined as the persistence of the Juvenile Arthritis Disease Activity Score (JADAS) state of inactive disease (ID) for at least 6 months. Efficacy will be compared by assessing the frequency (proportion) of clinical remission at 18 months (6 months after randomization for entrance in Phase B) in switched versus non-switched cohorts."}

Italy

Earliest CTIS Part Ii Submission Date

26-07-2024

Latest Decision Or Authorization Date

17-04-2025

Processing Time Days

265

Number Of Sites

17

Number Of Participants

290

Primary sponsor

Full Name

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"Italian Medicine Agency (AIFA) Independent clinical research","duties_or_roles":"Source of monetary support","organisation_type":""}