An Open-label Study of Leukocyte Counts in the Cerebrospinal Fluid and Blood of Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment With Firategrast
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Assessment of total leukocytes in blood
研究概览
简要总结
This is a study to count the number of white blood cells in the cerebrospinal fluid and blood at the beginning and end of treatment with firategrast and at 4 and 12 weeks after stopping firategrast. Cerebrospinal fluid flows through and protects the brain and spinal cord. It is important to understand what happens to the number of white blood cells because they are important in preventing infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
firategrast
900 (females) or 1200 (males) mg twice daily for 24 weeks
干预措施: firategrast (Drug)
结局指标
主要结局
Assessment of total leukocytes in blood
时间窗: Baseline (Week 0), Week 4, 24, 28 and 36
Total leukocyte count in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. Blood sample data presented are results from the independent assessor.
Assessment of total leukocytes in cerebrospinal fluid (CSF)
时间窗: Baseline (Week 0), Week 24, 28 and 36
Total leukocyte count in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. CSF sample data presented are results from the local clinical laboratory.
Change from Baseline in number of total leukocytes in CSF
时间窗: Baseline (Week 0) and Week 24, 28 and 36
Total leukocyte count in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. CSF sample data presented are results from the local clinical laboratory. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
Change from Baseline in lymphocyte subset CD4 count in CSF
时间窗: Baseline (Week 0) and Week 24, 28, 36
The count for CD4 cells in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
Change from Baseline in lymphocyte subset CD4 count in blood
时间窗: Baseline (Week 0) and Week 4, 24, 28, 36
The count for CD4 cells in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
Assessment of lymphocyte subset CD8 count in CSF
时间窗: Baseline (Week 0), Week 24, 28 and 36
The count for CD8 cells in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor.
Assessment of lymphocyte subset CD8 count in blood
时间窗: Baseline (Week 0), Week 4, 24, 28 and 36
The count for CD8 cells in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor.
Change from Baseline in CD4:CD8 ratio in CSF
时间窗: Baseline (Week 0) and Week 24, 28, 36
The count for CD4:CD8 ratio in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
Change from Baseline in number of total leukocytes in blood
时间窗: Baseline (Week 0) and Week 4, 24, 28, 36
Total leukocyte count in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. Blood sample data presented are results from the independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
Assessment of total lymphocytes in CSF
时间窗: Baseline (Week 0), Week 24, 28 and 36
Total lymphocyte count in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All the data presented are based on results from independent assessor.
Assessment of total lymphocytes in blood
时间窗: Baseline (Week 0), Week 4, 24, 28 and 36
Total lymphocyte count in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All the data presented are based on results from independent assessor.
Change from Baseline in number of lymphocyte subsets in blood (CD3+CD4+CD8+, CD19+, CD3-CD16+CD56+, CD3+CD4-CD8-)
时间窗: Baseline (Week 0) and Week 4, 24, 28, 36
The count for lymphocyte subsets CD3+CD4+CD8+ "double positives" (T-lymphocyte), CD3+CD4-CD8- "double negatives" (T-lymphocyte), CD19+ (B-lymphocyte) and CD3-CD16+CD56+ (natural killer cells) in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All the data presented are based on results from independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
Change from Baseline in lymphocyte subset CD8 count in CSF
时间窗: Baseline (Week 0) and Week 24, 28, 36
The count for CD8 cells in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
Change from Baseline in number of total lymphocytes in CSF
时间窗: Baseline (Week 0) and Week 24, 28, 36
Total lymphocyte count in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All the data presented are based on results from independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
Change from Baseline in number of total lymphocytes in blood
时间窗: Baseline (Week 0) and Week 4, 24, 28, 36
Total lymphocyte count in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All the data presented are based on results from independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
Assessment of lymphocyte subsets in CSF (CD3+CD4+CD8+, CD19+, CD3-CD16+CD56+, CD3+CD4-CD8-)
时间窗: Baseline (Week 0), Week 24, 28 and 36
The count for lymphocyte subsets CD3+CD4+CD8+ "double positives" (T-lymphocyte), CD3+CD4-CD8- "double negatives" (T-lymphocyte), CD19+ (B-lymphocyte) and CD3-CD16+CD56+ (natural killer cells) in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All the data presented are based on results from independent assessor.
Change from Baseline in number of lymphocyte subsets in CSF (CD3+CD4+CD8+, CD19+, CD3-CD16+CD56+, CD3+CD4-CD8-)
时间窗: Baseline (Week 0) and Week 24, 28, 36
The count for lymphocyte subsets CD3+CD4+CD8+ "double positives" (T-lymphocyte), CD3+CD4-CD8- "double negatives" (T-lymphocyte), CD19+ (B-lymphocyte) and CD3-CD16+CD56+ (natural killer cells) in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All the data presented are based on results from independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
Assessment of lymphocyte subsets in blood (CD3+CD4+CD8+, CD19+, CD3-CD16+CD56+, CD3+CD4-CD8-)
时间窗: Baseline (Week 0), Week 4, 24, 28 and 36
The count for lymphocyte subsets CD3+CD4+CD8+ "double positives" (T-lymphocyte), CD3+CD4-CD8- "double negatives" (T-lymphocyte), CD19+ (B-lymphocyte) and CD3-CD16+CD56+ (natural killer cells) in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All the data presented are based on results from independent assessor.
Assessment of lymphocyte subset CD4 count in CSF
时间窗: Baseline (Week 0), Week 24, 28 and 36
The count for CD4 cells in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor.
Assessment of lymphocyte subset CD4 count in blood
时间窗: Baseline (Week 0), Week 4, 24, 28 and 36
The count for CD4 cells in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor.
Change from Baseline in lymphocyte subset CD8 count in blood
时间窗: Baseline (Week 0) and Week 4, 24, 28, 36
The count for CD8 cells in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
Assessment of CD4:CD8 ratio in CSF
时间窗: Baseline (Week 0), Week 24, 28 and 36
The count for CD4:CD8 ratio in the CSF was done at Baseline (Week 0), Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor.
Assessment of CD4:CD8 ratio in blood
时间窗: Baseline (Week 0), Week 4, 24, 28 and 36
The count for CD4:CD8 ratio in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor.
Change from Baseline in CD4:CD8 ratio in blood
时间窗: Baseline (Week 0) and Week 4, 24, 28, 36
The count for CD4:CD8 ratio in the blood was done at Baseline (Week 0), Week 4, Week 24, Week 28 and Week 36. All data presented are based on results from the independent assessor. Baseline was defined at Week 0. Change from Baseline is the value at indicated time points minus the Baseline value.
次要结局
- Cumulative total number of enhancing Lesions at Week 24(Week 24)
- Cumulative number of persistent gadolinium-enhancing lesions at Week 24(Week 24)
- Number of participants with adverse events (AEs) and Serious adverse events (SAEs)(Up to Week 24)
- Assessment of CD34+ cells in the blood(Baseline (Week 0), Week 4, 24, 28 and 36)
- Change from Baseline in number of CD34+ cells in the blood(Baseline (Week 0) and Week 4, 24, 28, 36)
- Cumulative number of new gadolinium-enhancing lesions at Week 24(Week 24)
- Cumulative volume of new gadolinium-enhancing lesions at Week 24(Week 24)
- Plasma and CSF levels of firategrast(Week 24, 28 and 36)
- The relationship between plasma concentration of firategrast and lymphocyte count in the CSF(Week 24, 28 and 36)
- The relationship between the presence of the A allele of rs887829 and bilirubin levels(Baseline (Week 0))
- The relationship between plasma concentration of firategrast and lymphocyte count in the blood(Week 24, 28 and 36)