Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Effects of Infliximab on Uveitis Disease Activity.
研究概览
简要总结
The primary objective of this study is to examine the efficacy of infliximab for the treatment of persistent uveitis in children. Participants (4-18 years of age) will be randomly assigned to either 5mg/kg or 10mg/kg dose of infliximab to be administered by intravenous infusion at four week intervals. Participant responses will be measured at at four to eight week intervals for up to ten months.
详细描述
Pediatric rheumatologists often use infliximab in the treatment of childhood uveitis, at this time there are no prospective studies for this use. Participants will be randomized to initial suggested dose of infliximab (5 mg/kg/dose vs 10 mg/kg/dose) and data will be collected prospectively with regard to ophthalmologic outcomes. Study participants will be followed for up to 10 months to determine efficacy and side effects, and an additional 30 days for safety reports. Descriptive statistics will be gathered on participant demographics, uveitis characteristics, change in immunosuppressive medications, number of responders, ophthalmologic measures and change in corticosteroid dose during the study period. Initial to final dose will be examined by paired t-test. The proportion of responders in the 5 mg/kg initial dose group will be compared to the 10 mg/kg/dose by a Chi-square or Fisher's exact test, depending on numbers available. Predictors of response will be examined by logistic regression.
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
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 4 to 18 years old,
- •Non-infectious uveitis
- •Persistent uveitis uncontrolled by topical medications, or unacceptable side effects of topical medications.
- •Failure of at least six weeks of treatment with a non-biological disease modifying agent such as methotrexate, cyclosporine, mycophenolate mofetil, or azathioprine.
- •Ability to provide informed consent (subject or parent/guardian)
- •Onset of uveitis < 16 years of age.
- •Topical ophthalmologic treatments allowed.
- •Systemic corticosteroid use at entry may be allowed.
- •Willingness to use acceptable contraception if sexually active for the duration of the study and for 6 months after receiving the last infliximab infusion.
- •Concomitant methotrexate must be taken at time of initiation of infliximab
- •Participant must be able to cooperate for a non-sedated slit lamp exam and visual acuity examination.
- •Negative Purified Protein Derivative (PPD) placed and read within 1 month of initiation of infliximab
- •The screening laboratory test results must meet the following criteria:
- •WBC (white blood cell count): within normal range for institution
- •ANC (absolute neutrophil count): within normal range for institution
- •Hemoglobin: greater than 10 grams/deciliter
- •Platelets: within normal range for institution
- •Serum Creatinine: within normal range for age
- •AST - aspartate aminotransferase - within normal range for institution
- •ALT - alanine aminotransferase- within normal range for institution
排除标准
- •Previous use of biologic medications for uveitis.
- •Intraocular steroid injection or ophthalmologic surgery within the preceding 3 months.
- •Uveitis due to trauma or intraocular surgery
- •Females who are pregnant, nursing, or planning pregnancy within 6 months after the last infliximab infusion.
- •Males who plan on fathering a child within 6 months after their last infliximab infusion.
- •A history of a known allergy to murine products.
- •Documentation of seropositivity for human immunodeficiency virus (HIV).
- •Documentation of a positive test for hepatitis B surface antigen or hepatitis C
- •A known history of a serious infection (e.g., hepatitis, pneumonia, or pyelonephritis) in the previous 3 months.
- •An opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
- •A concomitant diagnosis or history of congestive heart failure.
- •A history of lymphoproliferative disease.
- •Any known malignancy or a history of malignancy.
- •Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
- •Use of any investigational drug within 30 days prior to screening or within five half-lives of the first dose of the investigational agent, whichever is longer.
- •Presence of a transplanted solid organ.
研究组 & 干预措施
1
5mg/kg/dose of infliximab IV every 4 weeks for 9 doses
干预措施: infliximab (Drug)
2
10mg/kg/dose of infliximab IV every 4 weeks for 9 doses.
干预措施: infliximab (Drug)
结局指标
主要结局
Effects of Infliximab on Uveitis Disease Activity.
时间窗: 9 months
Number of subjects with improvement in uveitis, defined as a two step decrease in level of inflammation (as defined by SUN criteria, AC cells, vitreous haze) or decrease to grade 0. A grading scheme of 0 indicating (\<1 cell/ocular field) low levels of inflammation to 4+ indicating (\>50 cells/ocular field) indicating high levels of inflammation.
次要结局
未报告次要终点
研究者
Egla C. Rabinovich
Associate Professor of Pediatrics
Duke University