2025-520923-25-00招募中3 期
Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis (SMART-JIA)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Minimal disease activity (MiDA) at Month 6 as assessed by the cJADAS10 less than or equal to 5
研究概览
简要总结
To evaluate the comparative effectiveness of treatment with each of 3 non-TNFi medications individually vs. treatment with a second TNFi to achieve minimal disease activity (MiDA; cJADAS10 less or equal to 5) at 6 months in children with Polyarticular course juvenile idiopathic arthritis (pcJIA) refractory to pre-trial TNFi treatment. The primary hypothesis is to establish superiority by showing that a higher proportion of children in each of the 3 non-TNFi treatment groups achieve MiDA at 6 months compared to children treated with a second TNFi.
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
- •Polyarticular course JIA
- •Moderate or high-disease activity (cJADAS10 >5) despite treatment with an initial TNFi for greater than or equal to 3 months
- •Age higher or equal to 2 years and <18 years and weight greater than or equal to 10 kg
- •No systemic glucocorticoids or systemic glucocorticoids at a stable dose of less or equal to 0.2 mg/kg/day (maximum 10 mg/day) for more or equal to 2 weeks prior to baseline visit
- •Documented informed consent/assent obtained from the parent/caregiver/patient
- •Females of childbearing potential are eligible only if they agree to use the required contraception methods or are not sexually active
排除标准
- •Systemic JIA
- •Any active acute, subacute, chronic, or recurrent bacterial, viral (including HIV, HCV, and HBV), or systemic fungal infection or any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completed within 4 weeks of the screening visit or oral antibiotics completed within 2 weeks of the screening visit. HBsAg positive and HBcAb negative: Participant is excluded from study. HBsAg negative and HBcAb positive and HBsAb negative: Participant is excluded from study. HCV Ab positive and HCV RNA positive: Participant is excluded from study (HCV RNA sample collection may be deferred and collected only if required to confirm eligibility in HCV Ab positive patients). HIV-1 or HIV-2 antibody positive: Participant is excluded from study.
- •Any medical history considered a contraindication/safety concern by the study investigator with the use of adalimumab, etanercept, tofacitinib, ABA, or an IL-6 inhibitor or their biosimilars. In particular, subjects at high risk for venous thromboembolism will be excluded. A subject may be at high risk for venous thromboembolism if they: - have heart failure or prior myocardial infarction within past 3 months; -have inherited coagulation disorders;-have had venous thromboembolism, either deep venous thrombosis or pulmonary embolism; -are undergoing major surgery or is immobilized.
- •Enthesitis-related arthritis/juvenile spondyloarthritis (2001 International League of Associations for Rheumatology [ILAR] criteria)
- •Pregnant or breastfeeding
- •History of or currently active inflammatory bowel disease
- •History of or currently active psoriasis
- •Active uveitis within 3 months of the baseline visit
- •History of or currently active sacroiliitis
- •History of or current malignancy
- •Active tuberculosis (TB) or a history of incompletely treated TB; Purified Protein derivative (PPD) or QuantiFERON-TB positive patients (without active TB) unless it is documented that the patient has been adequately treated for TB and can start treatment with a biologic agent, based on the medical judgment of the site investigator and/or an infectious disease specialist; suspected extrapulmonary TB infection; or at high risk of contracting TB, such as close contact with individual with active or latent TB.
- •Prior treatment with non-TNFi bDMARDs and/or any JAKi
- •Prior treatment with more than one TNFi molecule; exposure to more than one biosimilar of the same TNFi molecule is allowed
- •Any live attenuated vaccine, such as varicella-zoster, oral polio, measles, mumps or rubella vaccines, within 4 weeks prior to the baseline visit and throughout the study. Killed or inactive vaccine may be permitted based on the investigator’s judgment.
- •History of hypersensitivity or allergic reaction to any study drug or any of its excipients (inactive ingredients).
- •Aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than or equal to 1.5 x upper limit of normal (ULN) for age and sex
- •Serum creatinine > 1.5 x ULN for age and sex
- •Platelet count <150 x 10^3/microlitre (<150,000/mm^3)
- •Hemoglobin less than or equal to 9.0 g/dL (less than or equal to 5.6 mmol/L)
- •White blood cell (WBC) count <3,000/mm^3 (<3.0 x 10^9/L)
- •Neutrophil count less than or equal to 2000/mm^3 (less than or equal to 2.0 x 10^9/L)
- •Absolute lymphocyte count less than or equal to 500 cells/m^3
结局指标
主要结局
Minimal disease activity (MiDA) at Month 6 as assessed by the cJADAS10 less than or equal to 5
Minimal disease activity (MiDA) at Month 6 as assessed by the cJADAS10 less than or equal to 5
次要结局
- PROMIS® pain interference at Month 6
- PROMIS® fatigue at Month 6
- PROMIS® mobility at Month 6
- Change in arthritis disease activity (cJADAS10 and JIA American College of Rheumatology Pediatric 70 [ACR 70]) at Month 6
- Change in arthritis disease activity (cJADAS10) at Month 12
研究者
IRCCS Istituto Giannina Gaslini, delegated by the Sponsor
Scientific
Duke Clinical Research Institute
研究点 (1)
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