Efficacy and safety of anti TNF-alfa biosimilar compared to originators in Juvenile Idiopathic Arthritis
- Conditions
- Juvenile Idiopathic ArthritisMedDRA version: 23.1Level: PTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2021-004031-86-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 290
- Children with a diagnosis of JIA according to the ILAR criteria, candidate to treatment with anti-TNF alpha drugs (etanercept or adalimumab) as per clinical indication and per treating physician/family decision
- Moderate to high disease activity despite methotrexate (MTX) treatment for at least 3 months
- Age 2 to 17 years at time of enrolment
- 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
- Patients should be naive for biologic therapy or should have failed one anti-TNF drug.
- 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
- Duly executed, written, informed consent obtained from the patient’s parents.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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
1.Children with systemic JIA according to ILAR criteria
2.Ongoing treatment in the screening phase with any other second-line agents (except methotrexate) or intravenous immunoglobulin
3.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, creatinine levels above the upper limit of normal, chronic proteinuria or hematuria (2–4_/4 on dipstick on 2 consecutive tests)
4.Positive serologic findings of hepatitis B or C
5.Active TB or a history of incompletely treated TB
6.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
7.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
8.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
9.History of inflammatory bowel disease, severe diverticulitis, or previous gastrointestinal perforation. Uncontrolled diabetes mellitus, defined as glycosylated hemoglobin (HbA1c) =9% at the screening visit
10.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
11.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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate, through a pragmatic trial, safety and efficacy of switching from the adalimumab and etanercept originator molecules versus their biosimilar competitors and vice-versa in children with JIA in clinical remission on anti-TNF medication.;Secondary Objective: - to evaluate if the efficacy and safety profile of biosimilars overlaps with that of bio-originators when a switch occurs in patients in clinical remission in current clinical practice<br>- To evaluate if the efficacy and safety profile of biosimilars overlaps with that of bio-originators in current clinical practice;Primary end point(s): Clinical remission;Timepoint(s) of evaluation of this end point: 18 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Rate of patients who achieve the status of Inactive disease<br>- Time to inactive disease<br>- Time spent in inactive disease<br>- Time to clinical remission<br>- Cumulative level of disease activity throughout the study period<br>- Rate of flares<br>- Rate of uveitis onset/flare<br>- Frequency of side effects of medications;Timepoint(s) of evaluation of this end point: 6-12-18 months from randomization