Phase 2, Multi-Center, Open-Label, Single-Dose, Single Arm, In-Clinic Study to Evaluate the Actual Human Use of Methotrexate Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device in Adult Patients With Rheumatoid Arthritis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Safe Usability of the VIBEX MTX Device for Subcutaneous (SC) Self-injection With Methotrexate (MTX) in Adult Patients With Rheumatoid Arthritis (RA) as Demonstrated by Successful Self-Injection
研究概览
简要总结
The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate.
详细描述
Primary objective:
- To assess the safe usability of the VIBEX MTX device for subcutaneous (SC) self-injection of methotrexate (MTX) in adult patients with rheumatoid arthritis (RA) after standardized training by site personnel and review of written instructions
Secondary objectives:
- To evaluate the reliability and robustness of the VIBEX MTX device
- To evaluate the safety and local tolerance of an SC self-injection of MTX using the VIBEX MTX device
- To evaluate the effectiveness and ease of use of the VIBEX MTX device patient education tools for SC self-injection
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients >18 years of age, diagnosed with Rheumatoid Arthritis
排除标准
- •Pregnant females
- •Any other clinically significant disease or disorder which, in the opinion of the investigator might put the subject at risk
研究组 & 干预措施
VIBEX MTX
VIBEX MTX dose based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status
干预措施: VIBEX MTX (Device)
结局指标
主要结局
Safe Usability of the VIBEX MTX Device for Subcutaneous (SC) Self-injection With Methotrexate (MTX) in Adult Patients With Rheumatoid Arthritis (RA) as Demonstrated by Successful Self-Injection
时间窗: 24 hours
A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device. The Assessment of Essential Tasks Questionnaire was completed by site personnel documenting a patient's performance of essential self-injection steps, including the following: 1. SC self-injection was administered by the patient 2. SC self-injection was intentional 3. self-injection was administered in an appropriate location on the abdomen 4. patient removed cap marked "1" 5. patient removed cap marked "2" 6. patient held device at injection site for 3 seconds 7. patient confirmed that the window was obstructed
次要结局
- Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools(24 hours)
- Safety of Vibex MTX Device(24 hours)
- Tolerance of Vibex MTX Device (Injection Site Pain Severity as Reported by Patient on VAS Scale - 0 mm = no Pain to 100 mm = Very Severe Pain)(24 hours)