An Open-Label, Multicenter Study Evaluating Patient Injection Satisfaction With Two Formulations of Glatiramer Acetate (GA) Using Autoject 2 as the Subcutaneous Injection Delivery Method.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 148
- 主要终点
- Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience
研究概览
简要总结
This is an open-label, multicenter study conducted at approximately 20 sites. Each patient will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall injection satisfaction.
详细描述
The study will consist of a 2 week treatment period with participants injecting their current therapy of Copaxone 20 mg/1.0 mL glatiramer acetate utilizing an autoject 2. All participants will then roll over to the new formulation of 20 mg/0.5 mL glatiramer acetate with an autoject 2 device for a 4 week treatment period. Patient satisfaction will be evaluated using an Experience Questionnaire throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Patients ≥ 18 years of age with a diagnosis of Relapse Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS)
- •Currently injecting glatiramer acetate 20 mg/1.0 mL per day subcutaneously (SC) for a minimum of 90 days utilizing the autoject 2 for glass syringe for a minimum of 75% of daily injections
- •Willing and able to complete all procedures and evaluations related to the study
- •Willing to continue to follow usual injection site preparation and routine adjunctive local injection site reactions (LISR) management techniques
- •Willing and able to provide written informed consent
排除标准
- •Currently using or treated with another immunomodulating therapy (IMT) in conjunction with GA in the 30 days prior to screening for this study
- •Currently using an investigational drug or using treatment with any other investigational agent in the 30 days prior to screening for this study
- •Pregnant or planning pregnancy or breastfeeding
- •Use of any other parenteral medications (e.g., intramuscular, SC, intravenous, etc.) either currently or in the past 30 days prior to screening for this study
- •Any other medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the Investigator
- •Unwilling to perform all daily injections with an autoject 2 device
- •Previous participation in any study evaluating the new 20 mg/0.5 mL formulation
研究组 & 干预措施
20 mg/0.5 mL Glatiramer Acetate
Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
干预措施: Glatiramer acetate 20 mg/0.5 mL (Drug)
结局指标
主要结局
Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience
时间窗: Week 2 (prior to first injection with 20 mg/0.5 mL formulation), Week 6 (after 4 weeks of treatment with 20 mg/0.5 mL formulation).
The Satisfaction with Injection Experience questionnaire consists of 5 questions where participants are asked to rate their injection experience over the past 2 weeks on ease of use, bother, acceptability, confidence to inject and satisfaction. The response options range from "strongly disagree" (score = 1) to "strongly agree" (score = 5). The composite score of Satisfaction with Injection Experience is defined as the mean of the five Likert questions. The composite score ranges from 1.0 to 5.0, with a score of 5.0 representing the most satisfaction with injection experience and a score of 1.0 representing the least satisfaction with injection experience.
次要结局
- Patient Injection Experience Preference(Week 4)