A 6-month, Multicenter, Open-label, Safety Study of VIMOVO (250 mg/20 mg, 375 mg/20 mg, and 500 mg/20 mg Naproxen/Esomeprazole) in Adolescents Aged 12 to 16 Years, Inclusive, With Juvenile Idiopathic Arthritis (JIA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug
研究概览
简要总结
A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.
详细描述
Study with completed results acquired from Horizon in 2024.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent or legal guardian is able to provide written informed consent and patient is able to provide written assent if appropriate.
- •Male and female adolescents aged 12 to 16 years at the time of enrollment.
- •Diagnosed with JIA, including all the International League of Associations for Rheumatology JIA subtypes: oligoarthritis, polyarthritis (both rheumatoid factor [RF]+ and RF-), psoriatic arthritis, enthesitis-related arthritis, undifferentiated arthritis, and systemic arthritis.
- •Based upon investigator judgment, it is determined appropriate for the patient to undergo 6 months of continuous treatment with VIMOVO.
- •Body weight > 31 kg (68.2 lbs) and within the 5th to 95th percentile of body mass index for age.
排除标准
- •In systemic JIA patients, presence of systemic features (ie, fever, rheumatoid rash, serositis, lymphadenopathy, macrophage activation syndrome) within 6 months prior to start of study drug.
- •Currently taking (ie, within 4 weeks prior to start of drug) naproxen > 20 mg/kg/day or > 1000 mg total daily dose.
- •Hemoglobin ≤ 8.5 g/dL.
- •Individuals who have cardiovascular or cerebrovascular disease, based on history or risk factors.
- •Any significant hepatic, renal, pulmonary, ophthalmologic, neurologic, or any other medical conditions indicated by medical/surgical history, physical, or laboratory examination that might put the patient at greater risk during the study.
研究组 & 干预措施
VIMOVO
Three VIMOVO strengths will be used in this study: 250 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 250/20), 375 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 375/20), and 500 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 500/20). The VIMOVO strength allocated to each participant will be determined by the participant's weight at baseline and based on investigator's discretion.
The target dose of the naproxen component will be within the range of 10-20 mg/kg/day divided twice daily (BID) with a maximum daily dose of 1000 mg.
干预措施: VIMOVO 250/20 (Drug)
VIMOVO
Three VIMOVO strengths will be used in this study: 250 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 250/20), 375 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 375/20), and 500 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 500/20). The VIMOVO strength allocated to each participant will be determined by the participant's weight at baseline and based on investigator's discretion.
The target dose of the naproxen component will be within the range of 10-20 mg/kg/day divided twice daily (BID) with a maximum daily dose of 1000 mg.
干预措施: VIMOVO 375/20 (Drug)
VIMOVO
Three VIMOVO strengths will be used in this study: 250 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 250/20), 375 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 375/20), and 500 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 500/20). The VIMOVO strength allocated to each participant will be determined by the participant's weight at baseline and based on investigator's discretion.
The target dose of the naproxen component will be within the range of 10-20 mg/kg/day divided twice daily (BID) with a maximum daily dose of 1000 mg.
干预措施: VIMOVO 500/20 (Drug)
结局指标
主要结局
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug
时间窗: SAEs were collected from signing of informed consent through Month 6 (or end of treatment) plus 14 days. AEs were collected from administration of VIMOVO through Month 6 (or end of treatment) plus 14 days.
An AE is defined as the development of an undesirable medical condition or the deterioration of a preexisting medical condition, whether or not considered causally related to treatment. An SAE is defined as an AE occurring during any study phase (ie, run-in, treatment, washout, follow-up), that fulfils one or more of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. AEs were considered treatment-emergent if they occurred after the first dose of study drug. Events were categorized as mild, moderate, and severe; participants were represented only with the maximum reported intensity.
次要结局
- Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t])(pre-dose, and up to 3 hours post-dose)
- PK of Esomeprazole: Oral Plasma Clearance (CL/F)(pre-dose, and up to 3 hours post-dose)
- PK of Esomeprazole: Absorption Rate Constant (Ka)(pre-dose, and up to 3 hours post-dose)
- PK of Esomeprazole: Oral Volume of Distribution (V/F)(pre-dose, and up to 3 hours post-dose)
- PK of Naproxen: Trough Plasma Concentrations(Month 1 and Month 3: pre-dose, and up to 3 hours post-dose)