NCT00958009已完成3 期
A Twelve-week, Phase IIIb, Open-label, Single-arm, Multicenter Trial to Evaluate Ease of Use of a Ready-to-use, Single-use Autoinjector (SA) for Self-injection in Subjects With Relapsing Multiple Sclerosis (RMS) Treated With Rebif® 44mcg Subcutaneously (sc), Three Times a Week (Tiw)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Proportion of Relapsing Multiple Sclerosis (RMS) Subjects Rating the Single-use Autoinjector as 'Easy to Use' or 'Very Easy to Use' for Self-injection in a User Trial Questionnaire
研究概览
简要总结
The purpose of this trial is to test the Single-Use Autoinjector for a) ease of use; b) multiple domains related to subject's acceptability and satisfaction, and c) reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with relapsing multiple sclerosis (RMS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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, 18-65 years of age, inclusive, at the time of informed consent signature
- •RMS diagnosed according to the McDonald criteria
- •Currently receiving Rebif® 44mcg sc tiw using manual injections and/or Rebiject II autoinjector for greater than twelve weeks
- •Capable of self-injecting using the single-use autoinjector
- •Be willing and able to comply with the study procedures for the duration of the trial
- •Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) Authorization before any study-related activities are carried out
- •Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential
排除标准
- •Have used any other injectable medications (i.e. for pain) on a regular basis during the week prior to Screening or throughout the duration of the trial (the administration of a single injection for treatment or prophylaxis of a condition unrelated to MS or Rebif® therapy (e.g., influenza or pneumococcus vaccination) will be acceptable)
- •Have received MS therapy other than Rebif® within twelve weeks prior to Screening or at any time during the trial (e.g., other disease modifying drugs, Rebif® New Formulation, combination therapy, immunomodulatory and/or immunosuppressive agents, including but not limited to any interferon, glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine, methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod, cladribine, total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment (e.g. natalizumab, alemtuzumab/Campath, anti- CD4), Intravenous immunoglobulin (IVIg), cytokines or anti-cytokine therapy) and telbivudine
- •Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 2.5x upper limit of normal (ULN), or alkaline phosphatase > 2.5x ULN, or total bilirubin > 2.5x ULN
- •Have inadequate bone marrow reserve, defined as a total white blood cell count < 3.0x 109/L, platelet count < 75x109/L, haemoglobin < 100g/L
- •Have complete transverse myelitis or bilateral optic neuritis
- •Have a history of alcohol or drug abuse
- •Have thyroid dysfunction
- •Have moderate to severe renal impairment
- •Have a major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
- •Have a history of seizures not adequately controlled by treatment
- •Have serious or acute cardiac disease, such as uncontrolled dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure
- •Have, in the opinion of the investigator, any visual, physical or cognitive impairment that would preclude the subject from self-injecting with the single-use autoinjector
- •Have a known hypersensitivity or allergy to interferon-beta or any of the excipients
- •Have participated in another clinical trial within the past thirty days
- •Are pregnant or attempting to conceive
结局指标
主要结局
Proportion of Relapsing Multiple Sclerosis (RMS) Subjects Rating the Single-use Autoinjector as 'Easy to Use' or 'Very Easy to Use' for Self-injection in a User Trial Questionnaire
时间窗: at 12 weeks
Data from the User Trial Questionnaire, Question 14 (Overall, how do you rate your experience with using the injection device?) Mean and confidence interval refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response.
次要结局
- Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes.(at 12 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Usability of an AI for M923 in Subjects With Moderate to Severe RARheumatoid ArthritisNCT02722044Momenta Pharmaceuticals, Inc.33
已完成
2 期
A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVONeovascular Age-related Macular DegenerationMacular EdemaRetinal Vein OcclusionNCT06176963Samsung Bioepis Co., Ltd.34
已完成
3 期
Study of Mepolizumab Autoinjector in AsthmaticsAsthmaNCT03099096GlaxoSmithKline159
已完成
2 期
A Phase 2B Open-Label, Single-Arm, Repeat-Dose Study to Evaluate the Reliability of an AutoinjectorSystemic Lupus ErythematosusNCT02124798GlaxoSmithKline95
已完成
3 期
Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis of the KneeOsteoarthritisNCT05377489Grünenthal GmbH714