NCT03284970已完成不适用
Effect of Interferon Beta-1a SC 44 µg Three Times Weekly (Tiw) (Rebif) and Dimethyl Fumarate (DMF, Tecfidera) on Infections and Lymphocytes in Patients 50 Years or Older From a Single Center Chart Review
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Percentage of Subjects With One or More Infections
研究概览
简要总结
This study will be a single center, retrospective, pilot study to determine the effect of Rebif (interferon beta-1a) and Tecfidera (dimethyl fumarate) on infections on total lymphocyte counts, grade of lymphopenia, Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) counts and ratios in subjects aged 50 years and above with Relapsing-Remitting Multiple Sclerosis (RRMS).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RRMS subjects who have been treated with interferon beta 1a SC 44 micro-gram thrice a week and dimethyl fumarate in inpatient or outpatient settings during the period from January 1, 2015 to December 31,
- •Subjects with at least one year of laboratory values post-index date to analyze lymphocyte counts, and CD4 and CD8 counts. The date of first blood draw for laboratory tests after January 1, 2015 will be defined as the subject's index date.
排除标准
- •Subjects who have been on treatment for less than 1 year after their index date.
结局指标
主要结局
Percentage of Subjects With One or More Infections
时间窗: Up to 12 months
次要结局
- Number of Opportunistic Infections per Subject(Baseline, 6 Months, 12 Months)
- Total Lymphocyte Levels(Baseline, 6 Months, 12 Months)
- Percentage of Subjects With Lymphopenia Grades I, II, III and IV(Baseline, 6 Months, 12 Months)
- Number of Serious Infections per Subject(Baseline, 6 Months, 12 Months)
- Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Ratio(Baseline, 6 Months, 12 Months)
- Percentage of Subjects With One or More Serious Infections(Baseline, 6 Months, 12 Months)
- Percentage of Subjects With One or More Opportunistic Infections(Baseline, 6 Months, 12 Months)
- Number of Infections per Subject(Baseline, 6 Months, 12 Months)
- Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Counts(Baseline, 6 Months, 12 Months)
- Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline, 6 Months, 12 Months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Effectiveness of Rebif® in Clinically Isolated Syndrome and Relapsing Multiple Sclerosis Using RebiSmart™Relapsing Multiple SclerosisClinically Isolated SyndromeNCT02254304Merck KGaA, Darmstadt, Germany106
已完成
2 期
Safety and Efficacy of Interferon-Beta-1a (Rebif®) for Treating Subjects With Acute Symptoms of Ulcerative ColitisUlcerative ColitisNCT00303381EMD Serono194
已完成
2 期
A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative ColitisActive Ulcerative ColitisNCT00616434Biogen123
已完成
3 期
Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple SclerosisRelapsing Multiple SclerosisNCT00906399Biogen1,516
已完成
3 期
A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian SubjectsHepatitis CNCT00249860EMD Serono257