A Phase IV, Randomized, Prospective, US-based, Multicenter, Cross-over Study Evaluating Subject Ease-of-use With Rebif® Rebidose® and Rebiject II® Autoinjectors in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With REBIF® 44 mcg Subcutaneously Three Times a Week
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 97
- 试验地点
- 23
- 主要终点
- Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) at Week 4
研究概览
简要总结
This is a Phase 4, prospective, open-label, randomized, cross-over, multicenter trial to evaluate ease-of-use with Rebif® Rebidose® and Rebiject II® autoinjectors in subjects with relapsing remitting multiple sclerosis (RRMS). Subjects will participate in the study for up to 10 weeks (including screening and treatment periods). The treatment period will last 8 weeks and include 12 self-injections using the Rebif® Rebidose® device and 12 self-injections using the Rebiject II® device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects, 18 to 65 years of age inclusive, at the time of informed consent signature
- •Diagnosis of RRMS
- •Receiving Rebif®, 44 microgram subcutaneously three times a week, by manual injection for at least 12 weeks before the screening assessment and previous use of either Rebif® Rebidose® or Rebiject II® devices is acceptable if they have not been using them for the past 12 weeks prior to study entry and if, in the judgment of the investigator, the subjects are not experienced users
- •Subject is capable of self-injecting using Rebif® Rebidose® and Rebiject II® injection devices
- •Subject is willing and able to comply with the study procedures for the duration of the trial
- •Signed, informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization before any trial-related activities are performed
- •Female subjects of childbearing potential must have a negative pregnancy test at screening to be included in the trial and must be willing to avoid pregnancy by using a highly effective method of contraception
- •Outpatient status at the time of screening
- •Stable disease status without a history of surgical procedure or hospitalization within 30 days prior to Study Day 1, and with no surgical intervention planned for the duration of the study
排除标准
- •Received MS therapy other than Rebif® within the 12 weeks before screening or at any time during the trial
- •Inadequate liver function and bone marrow reserve as defined in the protocol
- •Current complete transverse myelitis, bilateral optic neuritis, or neuromyelitis optica
- •History of injection-site necrosis within 12 months before study entry
- •History of alcohol or drug abuse in the past year
- •Any autoimmune disorder, except for thyroid disease stable on medication
- •Subject having moderate to severe renal impairment, in the Investigator's opinion.
- •Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
- •Participation in another clinical trial within the past 30 days or an interventional trial for MS in the past 12 weeks
- •Use of high-dose steroids within 14 days of screening
- •Currently experiencing moderate to severe active inflammatory skin disease at sites of expected Rebif® injections
- •History of clinically significant lipoatrophy at sites of expected Rebif® injections, in the investigator's opinion
- •Current major depression or suicidal ideation or suicide attempt in the past year
- •Experiencing spasticity which in the opinion of the Investigator, could interfere with self-injections
- •Pregnant or lactating
- •Inability to self-inject or visual impairment which, in the opinion of the Investigator, is severe enough, even with correction, to impede the subject's participation in this study
- •Upper extremity deficit which, in the opinion of the Investigator, is severe enough to impede the subject's participation in this study
- •Cognitive deficit which, in the opinion of the Investigator, is severe enough to impede the subject's participation in this study
- •Subject-reported reason that he/she cannot complete the 8-week study
- •Any other medical condition, which in the opinion of the Investigator makes the subject unsuitable for this study
- •Known hypersensitivity to the trial treatment
结局指标
主要结局
Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) at Week 4
时间窗: Week 4
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as "easy" or "very easy" were reported. Here results are presented by device sequence.
Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) up to Week 8
时间窗: Baseline up to Week 8
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as "easy" or "very easy" were reported. Here results are presented by device used.
Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) at Week 8
时间窗: Week 8
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as "easy" or "very easy" were reported. Here results are presented by device sequence.
次要结局
- Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)(Weeks 4 and 8)
- Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)(Weeks 4 and 8)
- Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)(Weeks 4 and 8)
- Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)(Weeks 4 and 8)
- Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)(Weeks 4 and 8)
- Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)(Weeks 4 and 8)
- Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)(Weeks 4 and 8)
- Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)(Weeks 4 and 8)
- Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)(Weeks 4 and 8)
- Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)(Weeks 4 and 8)
- Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)(Weeks 4 and 8)
- Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)(Weeks 4 and 8)
- Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8(Baseline, up to Week 8)
- Percentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)(Weeks 4 and 8)