NCT02076841已完成不适用
Tolerability and Quality of Life in Patients With Multiple Sclerosis Switched to Intramuscular Interferon Beta 1a Autoinjector (Avonex® PenTM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline to month 4 in injection site tolerability as measured on a composite visual analogue scale (VAS) score ranging from 0-100
研究概览
简要总结
To evaluate treatment tolerability, adherence and quality of life (QoL) over 1 year in MS (Multiple Sclerosis) participants who have been switched - due to persistent tolerability issues, particularly injection problems - from a subcutaneous injectable disease-modifying treatment (DMT) given several times a week (Rebif, Betaferon or Copaxone) to once weekly Avonex 30 μg given intra-muscularly. Avonex will be applied by the injection device Avonex Pen.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Continuous treatment with Rebif, Betaferon or Copaxone over at least the past year.
- •Injections site tolerability issues documented in medical records or by a nurse at inclusion.
- •Clinically stable (free from relapses and 6-month confirmed disability progression for at least 6 months) while on therapy.
- •Documented neurological history at least for the year prior to study entry.
- •Qualification for Avonex® (Avonex Pen) according to the approved indication (Clinical Isolated Syndrome) or Relapsing Remitting Multiple Sclerosis (RRMS).
- •Acceptance of magnetic resonance imaging.
排除标准
- •Patients who have previously entered this study.
- •Treatment with Avonex during the 12 months prior to the study.
- •One or more relapses and/or 6-month confirmed disability progression during the 6 months prior to the study.
- •Patient on Betaferon with Neutralizing Antibodies (NAbs) more than 400 TRU (tenfold reduction units) and patients on Rebif with NAbs with more than 100 TRU.
- •Secondary progressive multiple sclerosis.
- •Primary progressive multiple sclerosis.
- •Pregnancy or breast feeding.
- •History of severe depression or attempted suicide or current suicidal ideation.
- •Medical or psychiatric conditions that compromise the ability to give informed consent, to comply with the protocol, or to complete the study.
- •Uncontrolled seizure disorder.
- •Myopathy or clinically significant liver disease.
- •Inability, in the opinion of the principal investigator or staff, to comply with protocol requirements for the duration of the study.
- •Known hypersensitivity to interferon-beta or other human proteins including albumin.
- •A history of drug abuse in the 6 months prior to screening.
- •Treatment with any of the following in the 30 days before day 1: systemic corticosteroids, ACTH, or other investigational drugs.
- •Participation in any other study involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study.
- •Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Change from baseline to month 4 in injection site tolerability as measured on a composite visual analogue scale (VAS) score ranging from 0-100
时间窗: Up to 4 months
次要结局
- Change from baseline to month 12 in injection site tolerability as measured on a composite VAS score(Up to 12 months)
- Change from baseline in the VAS score of systemic tolerability(Up to 12 months)
- The percentage of participants still on Avonex Pen(Up to 12 months)
- Change in Fatigue Scale for Motor and Cognitive functions (FSMC) score(Up to 12 months)
- The percentage of missed injections(Up to 12 months)
- Quality of Life as assessed by the change in Short Form (SF) Health Survey, SF-36 scores(Up to 12 months)
研究者
研究点 (1)
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