A Phase IV, Prospective, Multicenter, Open Label, Uncontrolled, Non-interventional, Single Arm Study to Measure Treatment Satisfaction of Multiple Sclerosis (MS) Patients on Rebif® After Discontinuing Initial First-line Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)
研究概览
简要总结
This is a prospective, multicenter, open label, uncontrolled, non-interventional, single arm study to measure treatment satisfaction of relapsing remitting MS (RRMS) participants on Rebif after discontinuing initial first-line treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 or female, 18 to 65 years of age (both inclusive), at the time of informed consent
- •Participants diagnosed with RRMS according to McDonald criteria 2010
- •Participants have discontinued treatment with dimethyl fumarate (Tecfidera), teriflunomide (Aubagio), glatiramer acetate (Copaxone®), intramuscular IFNβ-1a (Avonex®), pegylated interferon (Plegridy®), subcutaneous IFNβ-1b (Betaferon®) or fingolimod (Gilenya®) within 6 months prior to Visit 1
- •Currently treated with Rebif using RebiSmart 2.0, for a maximum of 6 months prior to Visit 1
- •Participants have a score on the Expanded Disability Status Scale (EDSS) between 0 to 5.0 inclusive
- •Participants willing and able to give informed consent.
排除标准
- •Participants have known planned surgical procedures at the time of the informed consent that will prevent adherence to treatment with Rebif through RebiSmart 2.0
- •Participants diagnosed with primary progressive, secondary progressive, or progressive relapsing MS
- •pregnant or lactating, or planning to become pregnant subjects
- •In the opinion of the Investigator has significant renal or hepatic impairment or other significant disease (e.g., cognitive or visual impairment) that would compromise adherence and completion of the study
- •Reports any reason that he/she cannot complete the 1 year study
- •Participants have a history of hypersensitivity to natural or recombinant interferon, or any other component of the formulation
- •Participants who contraindicated for the treatment with subcutaneous IFNβ-1a therapy as per summary of product characteristics or currently approved specific country product information
- •Participants have any other factor that in the opinion of the Investigator would make the subject unsuitable for participation in this study
- •Participants have significant psychiatric symptoms that, in the opinion of the Investigator, would impact patient ability to comply with treatment recommendations.
研究组 & 干预措施
Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
干预措施: Rebif (Drug)
结局指标
主要结局
Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)
时间窗: Month 6
TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across a wide variety of medication types and illness conditions. It consists 11 question items. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging from 1 to 7, where 1= Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied.
Treatment Satisfaction Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)
时间窗: Month 12
TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across a wide variety of medication types and illness conditions. It consists 11 question items. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging from 1 to 7, where 1= Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied.
次要结局
- Number of Participants Discontinued From Initial MS Treatment (Oral or Injectable) by Reason for Discontinuation(Baseline)
- Number of Participants With Adherence to Treatment(Month 6 and Month 12)
- Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Month 6 and 12(Month 6, Month 12)
- Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Adherence(up to 12 months)
- Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Annualized Relapse Rate (ARR)(up to 12 months)
- Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscales and Reasons for Discontinuation(up to 12 months)
- Annualized Relapse Rate (ARR)(Month 12)
- Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Annualized Relapse Rate (ARR)(up to 12 months)
- Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Adherence(up to 12 months)
- Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Reason for Discontinuation(up to 12 months)
- Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscales and Adherence(up to 12 months)
- Change From Baseline in Annualized Relapse Rate (ARR) at Month 12(Baseline, Month 12)
- Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Reason for Discontinuation(up to 12 months)
- Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscale Score at Month 6 and Month 12(Baseline, Month 6, Month 12)
- Correlation Between Annualized Relapse Rate (ARR) and Treatment Adherence(up to 12 months)