NCT00472797已完成3 期
A Randomized, Multicenter, Two-arm, 12 Week Phase IIIb Study to Evaluate Quality of Life (QOL) Measures in Subjects With Relapsing Forms of Multiple Sclerosis (MS) Who Are Transitioning From Rebif® (Interferon Beta-1a) to Rebif New Formulation (RNF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)
研究概览
简要总结
To evaluate the impact on Quality of Life (QOL), tolerability, treatment satisfaction, and injection site redness Rebif treated subjects with relapsing forms of MS who transition to a new formulation of Rebif (RNF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with a relapsing form of MS; diagnosis of MS is in accordance with the McDonald criteria
- •Subject currently taking Rebif 44mcg tiw, and has been on this treatment for at least 6 months (24 weeks) prior to study enrollment
- •Subject currently using Rebiject II and 29 gauge needle
- •Subject is between 18 and 60 years old inclusive
- •Subject is able to read and understand English
- •Subject is willing to follow study procedures
- •Subject has given written informed consent and signed HIPAA
- •Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either: i) Being post-menopausal or surgically sterile, or ii) Using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study. (Confirmation required within 30 days prior to start of the study)
排除标准
- •Use of any other injectable medications on a regular basis during the week prior to the screening period or during the screening or treatment periods. Receiving a single injection for treatment or prophylaxis of a condition unrelated to the subject's multiple sclerosis or the subject's Rebif® therapy (e.g., receiving a influenza or pneumococcus vaccination) is acceptable
- •Subject receiving MS therapy in addition (i.e., combination therapy) to Rebif® within 3 months prior to study enrollment or at any time during study protocol.
- •Subjects who have previously been on Rebif New Formulation (RNF).
- •Subject with progressive forms of Multiple Sclerosis (MS).
- •Subject with history of any chronic pain syndrome.
- •Subject has any other disease apart from MS that could better explain the subjects signs and symptoms.
- •Subject has complete transverse myelitis or bilateral optic neuritis.
- •Subjects that use any investigational drug or experimental procedure within 12 weeks of visit
- •Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1 (prior to enrollment).
- •Subject has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase > 2.5 times the upper limit of the normal values.
- •Subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
- •Subject suffers from other current autoimmune disease.
- •Subject suffers from 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
- •Subject is pregnant or attempting to conceive
- •Visual or physical impairment that precludes completion of diaries and questionnaires.
研究组 & 干预措施
1
Active Comparator
Rebif New Formulation - Non Titrated
干预措施: Rebif New Formulation Non Titrated (Drug)
2
Active Comparator
Rebif New Formulation - Titrated
干预措施: Rebif New Formulation Titrated (Drug)
结局指标
主要结局
Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)
时间窗: % change from Baseline to Week 12
The MSTCQ Global Side Effect domain assesses the degree of satisfaction on global side effect questions 9, 10 \& 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied). Percent change calculated as 100% \* (score at week 12 - score at baseline) / score at baseline.
次要结局
- Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)(Baseline and Week 12)
- Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)(Baseline to Week 12)
- Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12(Baseline to Week 12)
- Tolerability in Pain Using Visual Analog Scale (VAS)(Baseline to Week 12)
- Tolerability - Redness at Injection Site(Baseline to Week 12 (LOCF))
研究者
研究点 (1)
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