跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT02064816
NCT02064816已完成4 期

Multicenter, Open-label, 12 Week, Phase IV Prospective Randomized Study Aimed at Evaluating Whether sc IFN Beta 1a (Rebif®) Administered in the Morning May Affect the Severity of Flu-like Syndrome and Patient-perceived Invisible Symptoms in Subjects With Relapsing Multiple Sclerosis

Merck KGaA, Darmstadt, Germany1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年5月31日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
200
试验地点
1
主要终点
Difference in Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Between Rebif Morning Administration and Rebif Evening Administration Groups at Week 12
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an open-label, multi-center, 12-week, randomized, controlled, parallel group, Phase 4 study to assess whether the morning administration of interferon beta 1a (Rebif®) leads to a lower severity of flu-like symptoms (FLS) as compared to the evening administration, in subjects with relapsing multiple sclerosis (RMS).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • •Males and females between 18 and 60 years of age
  • •Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential. Furthermore, female subjects must not have been pregnant from at least three months prior to enter in the study
  • •Subjects have RMS according to the revised McDonald Criteria (2010)
  • •Subjects with an expanded disability status scale (EDSS) score of less than 6.0
  • •Subjects naive to treatment and eligible for treatment with Rebif® 44 three times a week, or patients having received glatiramer acetate with a wash-out from at least one month, or patients having received treatment with natalizumab or fingolimod with a wash-out from at least three months
  • •Subjects able to self-inject treatment using RebiSmart®
  • •Subjects willing and able to comply with the protocol for the duration of the study
  • •Subjects have given written informed consent to take part in the study

排除标准

  • •Subjects have any disease other than MS that could better explain his/her signs and symptoms
  • •Subjects who have received any immunosuppressive agents within 3 months prior to Baseline
  • •Subjects who have received any corticosteroids within 30 days prior to Baseline
  • •Subjects have a MS relapse within 30 days prior to Baseline
  • •Subjects have inadequate liver function and bone marrow reserve as defined in the protocol
  • •Subjects have moderate to severe renal impairment
  • •Subjects have any visual or physical impairment that precludes the subjects from self-injecting the treatment using RebiSmart®
  • •Subjects have hypersensitivity to natural or recombinant interferon, or to any of its excipients
  • •Subjects have any contra-indications to treatment with interferon (IFN) beta 1a according to Summary of Product Characteristics (SmPC)
  • •Subjects have any contra-indications to treatment with ibuprofen/paracetamol according to SmPC
  • •Obese subjects, defined by body mass index greater than 30 kilogram per square meter (kg/m^2)
  • •Subjects have participated in any other investigational trial within 30 days from Baseline
  • •Subjects have any other significant disease that in the Investigator's opinion would exclude the subject from the trial

研究组 & 干预措施

Rebif® Morning Administration

Experimental

干预措施: Rebif® (Drug)

Rebif® Evening Administration

Experimental

干预措施: Rebif® (Drug)

结局指标

主要结局

Difference in Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Between Rebif Morning Administration and Rebif Evening Administration Groups at Week 12

时间窗: Week 12

The MSTCQ was used as a tool to measure treatment satisfaction, focusing on the attributes specific to multiple sclerosis (MS) medications. The FLS subscale of MSTCQ was defined as the sum of the scores for questions 13 to 16 with a minimum possible total FLS score = 1 and a maximum possible total FLS score = 20. Lower score indicates lower flu like symptoms and better satisfaction. Difference between Rebif Morning Administration and Rebif Evening Administration groups at Week 12 is presented in statistical analysis section.

次要结局

  • Correlation Between Change From Baseline in Circulating Levels of Cytokines (Leptin, Resistin and Adiponectin) and in Flu Like Symptom (FLS) Score at Week 12(Baseline and Week 12)
  • Difference in Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Between Rebif Morning Administration and Rebif Evening Administration Groups at Week 4 and 8(Week 4 and 8)
  • Difference in Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Subscale Scores Between Rebif Morning Administration and Rebif Evening Administration Groups at Week 4, 8 and 12(Week 4, 8 and 12)
  • Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 4, 8 and 12(Baseline, Week 4, 8 and 12)
  • Change From Baseline in Fatigue Severity Scale (FSS) Score at Week 4, 8 and 12(Baseline, Week 4, 8 and 12)
  • Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 4, 8 and 12(Baseline, Week 4, 8 and 12)
  • Change From Baseline in Circulating Levels of Cytokines at Week 12(Baseline and Week 12)
  • Correlation Between Change From Baseline in Circulating Levels of Cytokines and in Other MSTCQ Items, HADS, FSS, PSQI and MusiQOL Scores at Week 12(Baseline and Week 12)
  • Change From Baseline in Cytokines (Leptin and Resistin) Levels at Week 12(Baseline and Week 12)
  • Change From Baseline in Cytokine (Adiponectin) Level at Week 12(Baseline and Week 12)
  • Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQOL) Score at Week 4, 8 and 12(Baseline, Week 4, 8 and 12)
  • Percentage of Subjects With Treatment Adherence at Week 4, 8 and 12(Week 4, 8 and 12)
  • Change From Baseline in Hormone-Like Cytokine (Interleukin-6, 10 and 12) Levels at Week 12(Baseline and Week 12)
  • Change From Baseline in Total Sleep Time (TST) and Rapid Eye Movement (REM) Sleep Time at Week 12(Baseline and Week 12)
  • Correlation Between Change From Baseline in Cytokines (Leptin, Resistin and Adiponectin) and Hormone-like Cytokine Levels (Interleukin-6, 10 and 12), and TST and REM Sleep Time at Week 12(Baseline and Week 12)
  • Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation(Baseline up to Week 12)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

招募中
4 期
Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.End Stage Renal Disease (ESRD)
NCT06597201Chengdu Qingshan Likang Pharmaceutical Co., Ltd400
已完成
4 期
Rebif® Rebidose® Versus Rebiject II® Ease-of-UseMultiple Sclerosis, Relapsing-Remitting
NCT02019550EMD Serono97
Unknown
4 期
Clinical Study of Artz in the Treatment of Knee OsteoarthritisKnee Osteoarthritis
NCT02826031Kunming Baker Norton Pharmaceutical Sales Co., Ltd.300
已完成
4 期
Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPFIdiopathic Pulmonary Fibrosis
NCT02579603Boehringer Ingelheim105
终止
4 期
A Phase IV Study in Drug-Naive Patients With T2DM in ChinaType 2 Diabetes Mellitus
NCT03344341AstraZeneca304