NCT02052167已完成1 期
Human Factors Study for the Evaluation of the Methotrexate Prefilled Pen (50 mg/mL) for Subcutaneous Injection in Pediatric and Adolescent Patients With Juvenile Idiopathic Arthritis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- medac GmbH
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of test case scenarios with observation and performance measures
研究概览
简要总结
This study is planned to evaluate the human factor (HF)/usability of pediatric or adolescent JIA patients and the caregivers of Juvenile Idiopathic Arthritis (JIA) patients with the Methotrexate Prefilled Pen (including a label comprehension assessment and a device robustness evaluation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •patient of either gender aged ≥2 to <21 years of age
- •is a suitable candidate for treatment with injectable methotrexate for JIA per the patient's primary rheumatologist, with the previous or current diagnosis of active polyarticular course JIA
排除标准
- •Is a female patient who is pregnant, trying to become pregnant, or breastfeeding, or of childbearing potential, sexually active but not practicing a highly reliable method of birth control during the study and at least 6 months thereafter
- •Has contraindications for methotrexate
- •Has a history of or current inflammatory arthritis or rheumatic autoimmune disease other than JIA
- •Is unable, or does not have a caregiver able to comprehend written labeling and training materials
研究组 & 干预措施
Methotrexate
Experimental
干预措施: methotrexate prefilled pen (Device)
结局指标
主要结局
Evaluation of test case scenarios with observation and performance measures
时间窗: 8 days
Test case scenarios were designed to determine if the potential risks associated with the use of the prefilled pen were mitigated by information contained in the patient leaflet and the training provided to each patient or caregiver. The test case scenarios with observation and performance measures will be evaluated.
次要结局
未报告次要终点
研究者
研究点 (1)
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