NCT00760435已完成3 期
Infliximab (Remicade®) Plus Intravenous Immunoglobulin (IVIG) for the Primary Treatment of Patients With Acute Kawasaki Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- The Number of Subjects in Each Arm That Have Persistent or Recrudescent Fever 24 Hours After Completion of the Intravenous Immunoglobulin (IVIG) Infusion
研究概览
简要总结
The purpose of this study is to determine whether the addition of infliximab to standard primary therapy of intravenous immunoglobulin (IVIG) and high dose aspirin will reduce resistance to therapy in acute Kawasaki disease (KD).
详细描述
KD, an orphan disease of low prevalence in U.S. children, causes significant long term cardiac sequelae in a subset of patients. KD patients that are resistant to therapy are more likely to develop coronary artery abnormalities. This phase III placebo-controlled, multicenter, randomized clinical trial of infliximab plus standard therapy vs. placebo plus standard therapy in acute KD will determine if the addition of infliximab to primary therapy can reduce the percentage of children resistant to therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Weeks 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All eligible subjects, or legal representative, must provide written informed consent/assent, prior to initiation of any study procedure.
- •Eligible subjects will be infants and children, 4 weeks to 17 years old, who have had fever for 3 to 15 days (illness day 1 = first day of fever ≥ 38.3° C)
- •Patients who meet one of the following sets of criteria will be eligible for enrollment (adapted from AHA guidelines: Newburger et al. 2004):
- •Case definition for complete KD: Fever (≥ 38.3°C) for ≥ 3 days and 4/5 standard clinical criteria (Table 1)
- •Case definition for incomplete KD: Fever ≥ 5 days and 2-3 clinical criteria plus either C-reactive protein (CRP) ≥ 3.0 mg/dL or ESR ≥40 mm/hr AND ≥ 3 supplemental laboratory criteria: albumin ≤ 3.0 g/dl, anemia for age, ALT ≥ 45, platelet count ≥ 450,000/mm3, white blood cell count ≥ 15,000/mm3, or urinalysis with ≥10 white blood cells/hpf.
- •Case definition for incomplete KD with echocardiogram data: Fever ≥ 5 days and <4/5 clinical criteria plus abnormal echocardiogram with z score of LAD or RCA ≥ 2.5
- •Females of childbearing potential and males must be using adequate contraception (abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) throughout the trial.
- •All eligible subjects must have a chest radiograph within one week prior to first infusion of study drug with no evidence of tuberculosis or other infection.
排除标准
- •Have been receiving corticosteroids (i.e. via any route) at doses > 1 mg/kg prednisone equivalent daily.
- •History of tuberculosis (TB) or TB exposure.
- •Have received a BCG vaccination within the past 6 months.
- •History of histoplasmosis or coccidioidomycosis
- •Have received anakinra (Kineret®), etanercept (Enbrel®), or adalimumab (Humira®) within 1 month prior to first study drug administration.
- •Have any chronic disease, except asthma, atopic dermatitis or controlled seizure disorder.
- •Have documented history of current active Hepatitis B or a history of Hepatitis C infection.
- •Have a documented history of human immunodeficiency virus (HIV) infection.
- •Have received a transplanted organ (with the exception of a corneal transplant performed > 3 months prior to the first study drug administration).
- •Have a known malignancy or history of malignancy within the 5-year period prior to first study drug administration (with the exception of basal cell or squamous cell carcinoma of the skin that has been completely excised without evidence of recurrence).
- •Have a history of prior lymphoproliferative disease including lymphoma.
- •Have multiple sclerosis or other central demyelinating disorder.
- •Have received any previous treatment with infliximab or other monoclonal antibodies
- •Have used any investigational drug within 1 month prior to first study drug administration or within 5 half-lives of the investigational agent, whichever is longer.
- •Are participating in another investigative trial, involving investigational agents, during participation in this trial.
- •Have a history of substance abuse (drug or alcohol) within the previous 3 years.
- •Are pregnant, nursing, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter.
- •Have a known allergy to murine proteins or other chimeric proteins.
- •Patients with ischemic congestive heart failure, defined by ECG changes, elevated Troponin 1 and CPK-MB consistent with myocardial ischemia.
- •Have an abnormal chest radiograph
- •Afebrile for ≥ 48 hours
研究组 & 干预措施
1
Experimental
Infliximab plus Intravenous immunoglobulin (IVIG)
干预措施: Infliximab (Drug)
2
Placebo Comparator
Placebo plus IVIG
干预措施: Placebo (Drug)
结局指标
主要结局
The Number of Subjects in Each Arm That Have Persistent or Recrudescent Fever 24 Hours After Completion of the Intravenous Immunoglobulin (IVIG) Infusion
时间窗: 10 weeks
次要结局
- Number of Days of Fever Following Therapy During Study Period (up to 6 Weeks)(up to 6 weeks)
- Change in C-reactive Protein (CRP) From Baseline at 24 Hours After Completion of Intravenous Immunoglobulin (IVIG) by Study Arm.(24 hours)
- Change From Baseline in Left Anterior Descending Coronary Artery Outcomes at Week 2 by Treatment Arm(2 weeks)
研究者
Jane C. Burns
Professor
University of California, San Diego
研究点 (2)
Loading locations...
相似试验
撤回
3 期
Efficacy of Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki DiseaseKawasaki DiseaseNCT04535518Children's Hospital of Fudan University
已完成
2 期
Infliximab Treatment Along With Pegylated Interferon and Ribavirin in the Treatment of Hepatitis CHepatitis CNCT00512278Nizar Zein146
已完成
1 期
Infliximab to Treat Non-Infectious ScleritisScleritisNCT00075075National Eye Institute (NEI)5
已完成
不适用
Efficacy of Infliximab as a second Bio in patients with refractory rheumatoid arthritisRheumatoid arthritisJPRN-UMIN000020799Hokkaido University Hospital, Medicine II30
已完成
3 期
A Study to Evaluate Safety and Efficacy of Infliximab in Chinese Participants With Moderate to Severe Plaque-type PsoriasisPsoriasisNCT01177800Xian-Janssen Pharmaceutical Ltd.129