2023-505051-43-00招募中3 期
Comparison of STep-up and step-down therapeutic strategies in childhood ARthritiS
Giannina Gaslini Institute For Scientific Hospitalization And Care20 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2024年9月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 20
- 主要终点
- Clinical remission on or off medication at 12 months.
研究概览
简要总结
to compare the effectiveness of a conventional therapeutic regimen, based on treatment escalation (Step-up strategy) and driven by the treat-to-target approach, with that of an early aggressive intervention based on a combination of conventional and biological DMARDs (Step-down strategy).
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •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
- •Active arthritis
- •Onset of JIA symptoms no more than 6 months before randomization, IV. Age 2 to 16 years at enrolment
- •Female of child-bearing potential must have a negative pregnancy test at the beginning of the trial. If sexually active, they must agree to use highly effective contraceptive measures, 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 highly effective contraceptive measures if sexually active
- •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
- •Duly executed, written, informed consent/assent obtained from the parents/patient
- •Age 2 to 16 years at enrolment
排除标准
- •Classification in one of the following JIA categories: systemic arthritis, RF-positive polyarthritis, psoriatic arthritis, enthesitis-related arthritis, undifferentiated arthritis
- •Patients who need systemic treatment for uveitis
- •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.
- •Previous treatment with any synthetic or biologic DMARD
- •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
- •Prior or current history of malignancy or any other significant concomitant illness(es) as per the treating physician evaluation
- •Any of the following laboratory abnormalities based on the most recent laboratory results: a. White blood cell (WBC) count <3.50 x 103/mm3 (SI units: <3.50 x 109/L) and neutrophils < 1x109/L; b. Hemoglobin < 8.5 g/dL (SI units: <85 g/L); c. Platelet Count < 125,0000/mm3 or ≥1,000,000/mm3 (SI units: <125 x 109/L or ≥1,000 x 109/L; d. Aspartate aminotransaminase (AST) or alanine aminotransaminase (ALT) ≥ 2.0 x upper limit of normal (ULN)
结局指标
主要结局
Clinical remission on or off medication at 12 months.
Clinical remission on or off medication at 12 months.
次要结局
- The rate of patients who achieve the JADAS/JIA ACR state of ID at any single point in time throughout the study period will be compared between the 2 arms.
研究者
Alessandro Consolaro
Scientific
Giannina Gaslini Institute For Scientific Hospitalization And Care
研究点 (20)
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