NCT00619307已完成3 期
A Randomized, Multicenter, Two-arm, Open-label, Phase IIIb Study to Evaluate the Satisfaction in Relapsing Multiple Sclerosis Subjects Transitioning to Rebif® New Formulation From Rebif® (Interferon Beta-1a) With Ibuprofen When Necessary (PRN) or as Prophylaxis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score
研究概览
简要总结
To assess patient satisfaction with respect to the incidence of flu-like symptoms (FLS) in patients with multiple sclerosis transitioned from current Rebif (subcutaneously injected interferon beta-1a, 44 mcg three-times-weekly) to the new formulation of Rebif (RNF) while receiving ibuprofen either prophylactically or only when necessary (PRN) after the occurence of flu-like symptoms.
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 relapsing forms of Multiple Sclerosis (MS)
- •Expanded disability status scale (EDSS) score < 5.5 at study entry
- •Subjects who have been administering Rebif 44 mcg three times a week for at least 6 months prior to study enrolment
- •Subject currently using Rebiject II and who will use their own Rebiject II for the Rebif New Formulation injections
- •Subject is between 18 and 60 years old inclusive
- •Female subjects must be neither pregnant nor breast-feeding and must lack childbearing potential, as defined by either: post-menopausal or surgically sterile, or use a highly effective method of contraception.
- •Subject is willing to follow study procedures
- •Subject is willing and must not present any contra-indication to taking ibuprofen during 4 weeks of the study
- •Subject has given written informed consent
排除标准
- •Secondary Progressive Multiple Sclerosis without superimposed attacks
- •Use of any other injectible medications during the week prior to the screening period, during the screening or treatment periods
- •Subject receiving MS therapy in addition (i.e. combination therapy) to Rebif within 3 months prior to study enrolment or at any time during study protocol
- •History of any chronic pain syndrome
- •Subjects that use any investigational drug or experimental procedure within 12 weeks of visit
- •Subject received corticosteroids or adrenocorticotrophic hormone (ACTH) within 30 days of visit 1
- •Subject with flu-like symptoms (FLS) associated with any cause (i.e. no current flu and no FLS related to Interferon in the week prior to baseline)
- •Subject has abnormal liver function, defined by a total bilirubin > 1.5 times the upper limit of normal, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of the normal values.
- •Subject has inadequate bone marrow reserve, defined as a total white blood cell count < 3.0 x 109/L, platelet count < 75 x 109/L, haemoglobin < 100 g/L.
- •Subject suffers from an active autoimmune disease other than MS
- •Subject suffers from major medical or psychiatric illness
- •Subject has seizures history or is currently experiencing seizures not adequately controlled by anti-epileptics
- •Subject is pregnant or attempting to conceive
- •Visual or physical impairment that precludes completion of diaries and questionnaires by himself/herself
- •Contraindication to ibuprofen:known hypersensitivity to the active ingredient ibuprofen
- •Known hypersensitivity to non-steroidal anti-inflammatory drugs which can lead to asthmatic attacks, gastric and/or intestinal ulcers, gastro-intestinal bleeding, cerebro-vascular bleeding or other active bleeding, severe hepatic dysfunction, severe kidney dysfunction, severe cardiac insufficiency, or systemic lupus erythematosus
研究组 & 干预措施
Transition with PRN ibuprofen
Active Comparator
干预措施: Rebif New Formulation + ibuprofen PRN (Drug)
Transition with prophylactic ibuprofen
Active Comparator
干预措施: Rebif New Formulation + prophylactic Ibuprofen (Drug)
结局指标
主要结局
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score
时间窗: 4 weeks
This is defined as the sum of the scores for the "side effects" section questions 1-4, with a minimum possible total score of 1 and a maximum possible total score of 20 in the MSTCQ. The lower the score, the better the outcome.
次要结局
- Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score(4 weeks)
- Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score(4 weeks)
- Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score(4 weeks)
- Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score(4 weeks)
研究者
研究点 (1)
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