EUCTR2021-004031-86-IT进行中（未招募）1 期
A randomized, two-armed, single-blind, parallel, active controlled, and non-inferiority clinical trial to Compare Efficacy and Safety ofanti TNF-alfa biosimilar molecules to the originators in children with active Juvenile Idiopathic Arthritis” - CEST-JIA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 290
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
排除标准
- •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
研究者
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