A Multicenter, Randomized, Open-Label Study of the Injection Time and Usability of the Physiolis Syringe and Autoinjector in Injection-Experienced Rheumatoid Arthritis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 20
- 主要终点
- Injection Duration for the Physiolis Autoinjector at Room Temperature (20° to 27°C) and at Storage Temperature (2° to 8°C) Compared to the Current Autoinjector Ejection Time Specification of Not More Than 10 Seconds
研究概览
简要总结
This was an open-label, Phase 2 study designed to obtain user experience data (Phase A) and injection time data (Phase B) in experienced adalimumab patients injected with the Physiolis pre-filled syringe and autoinjector used to administer adalimumab.
详细描述
This was a Phase 2, open-label study consisting of 2 study phases with a total of 3 study visits, each visit occurring 2 weeks apart from each other. Phase A (User Experience) was a randomized, 2-period, cross-over phase in which single subcutaneous (SC) dose injections were administered using either the Physiolis autoinjector and current autoinjector or the Physiolis syringe and current syringe in a 1:1 ratio. Phase B (Injection Time) was a randomized, single-visit, parallel-arm phase, with injection into a test tube, and one SC injection given to participants using the Physiolis autoinjector or current autoinjector administered at 2 different temperature ranges (2° to 8°C [storage temperature] and 20° to 27°C [room temperature]). If a participant only completed Visit 1 and Visit 2, then the participant was to be replaced for Visit 3. If the participant only completed Visit 1, the participant was to be replaced for all study visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Subject was judged to be in good health as determined by the investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray, and a 12-lead electrocardiogram performed during Screening.
- •Subject had a negative purified protein derivative (PPD) test (or equivalent) and chest x-ray (posterior-anterior and lateral view) at Screening.
- •Subject has a diagnosis of moderate to severe rheumatoid arthritis and is treated with adalimumab in accordance with the FDA-approved Humira prescribing information.
- •Subject must have self-administered adalimumab subcutaneous (SC) 40 mg injections every other week (eow) without interruption for at least 3 months prior to Screening.
- •For the Phase A portion of the study, the subject must be able and willing to self administer SC injections in the thigh or abdomen (administration by another person was not permissible).
排除标准
- •Subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to the Visit 1, with the exception of adalimumab.
- •Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Visit 1 or oral anti-infectives within 14 days prior to Visit
- •Prior exposure to natalizumab (Tysabri®) or efalizumab (Raptiva®).
- •Known hypersensitivity to adalimumab or its excipients.
- •Regular use of any SC medications, with the exception of adalimumab.
研究组 & 干预措施
Current/Physiolis Syringe
Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2) (Phase A)
干预措施: Adalimumab delivered in current syringe (Device)
Current/Physiolis Syringe
Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2) (Phase A)
干预措施: Adalimumab delivered in Physiolis syringe (Device)
Physiolis/Current Syringe
Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2) (Phase A)
干预措施: Adalimumab delivered in current syringe (Device)
Current Autoinjector 2° to 8°C
Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
干预措施: Adalimumab delivered in current autoinjector (Device)
Physiolis/Current Syringe
Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2) (Phase A)
干预措施: Adalimumab delivered in Physiolis syringe (Device)
Current/Physiolis Autoinjector
Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2) (Phase A)
干预措施: Adalimumab delivered in current autoinjector (Device)
Current/Physiolis Autoinjector
Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2) (Phase A)
干预措施: Adalimumab delivered in Physiolis autoinjector (Device)
Physiolis/Current Autoinjector
Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2) (Phase A)
干预措施: Adalimumab delivered in current autoinjector (Device)
Physiolis/Current Autoinjector
Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2) (Phase A)
干预措施: Adalimumab delivered in Physiolis autoinjector (Device)
Physiolis Autoinjector at 2° to 8°C
Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)
干预措施: Adalimumab delivered in Physiolis autoinjector (Device)
Physiolis Autoinjector 20° to 27°C
Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
干预措施: Adalimumab delivered in Physiolis autoinjector (Device)
Current Autoinjector 20° to 27°C
Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
干预措施: Adalimumab delivered in current autoinjector (Device)
结局指标
主要结局
Injection Duration for the Physiolis Autoinjector at Room Temperature (20° to 27°C) and at Storage Temperature (2° to 8°C) Compared to the Current Autoinjector Ejection Time Specification of Not More Than 10 Seconds
时间窗: Phase B (Week 4)
A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible "click," until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C).
Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector
时间窗: Phase A (Week 0 and Week 2)
Participant's overall satisfaction of the injection was collected on a 10-cm visual analog scale (VAS) completed by participants immediately after self-injection. 0 = extremely unsatisfied, 10 = extremely satisfied.
次要结局
- Injection Duration for the Current Autoinjector Compared to the Physiolis Autoinjector(Phase B (Week 4))
- Injection Duration for the Current Autoinjector When Administered at Room Temperature (20° to 27°C) Versus the Storage Temperature (2° to 8°C)(Phase B (Week 4))