EUCTR2006-007057-42-BE进行中（未招募）不适用
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
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •2. Male or female, age 18 to 65.
- •3. A diagnosis of a relapsing form of MS [As per McDonald, 2001; Polman, 2005], with dissemination in time and space.
- •4. Expanded Disability Status Scale (EDSS) score of between 0 and 6.5 inclusive.
- •5. Occurrence of at least one clinical attack in the previous 24 months, but not within the 4 weeks prior to Screening or prior to the Baseline Visit.
- •6. A minimum of two T2 lesions on brain MRI at Screening, as determined by the central MRI analysis reader.
- •7. A female subject is eligible to enter the study if she is:
- •a. Of non-childbearing potential OR
- •b. Of childbearing potential, has a negative urine pregnancy test at Screening and Baseline, and agrees to consistent and correct use the method of contraception as per the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects receiving corticosteroids within 4 weeks of Screening for treatment of MS.
- •2. Use of a beta-interferon product, glatiramer acetate or azathioprine within 3 months of Screening, or use of Mitoxantrone within 12 months of Screening.
- •3. Previous exposure to alemtuzumab, natalizumab or firategrast administration, bone marrow transplantation or whole body irradiation.
- •4. Subjects with a cardiac pacemaker or any other type of metal implant or with any other contraindication for MRI.
- •5. Use of 4-aminopyridine, rosiglitazone, pioglitazone or any drug that is an inhibitor of or a substrate (with a low therapeutic index) for Organic Anion Transporter Protein (OATP).
- •6. Subjects with clinically significant renal laboratory values: subjects with a calculated creatinine clearance <60ml/min (by Cockcroft and Gault) at Screening.
- •7. Subjects with local urinalysis findings of 1) proteinuria, defined as greater than or equal to 1+ protein on urine dipstick or 2) renal tubular cell casts or 3) greater than or equal to 5 red blood cells / high power field will be excluded from the study if the result is still present on a repeat urinalysis during the Screening Phase.
- •8. Presence of clinically significant hepatic laboratory values: ALT, AST, GGT > 2 times the upper limit of the reference range; total bilirubin > 1.5 the upper limit of the normal range.
- •9. CD4 count < 500, CD4:CD8 < 1.0, JCV viremia in plasma or white cells, idiopathic CD4/CD8 lymphopenia or secondary lymphopenia at Screening.
- •10. Any findings at Screening on the MRI of the brain other than MS, except for benign findings.
- •11. Uncontrolled or any active bacterial, viral, or fungal infection.
- •12. History of tuberculosis (TB) or positive chest X-ray for TB at Screening.
- •13. Known congenital or acquired immunodeficiency.
- •14. Current or history of cancer, excluding localized non-melanoma skin cancer.
- •15. Any abnormality on 12-lead Electrocardiogram (ECG) at Screening.
- •16. Positive hepatitis B surface antigen, hepatitis C antibody or HIV tests at Screening.
- •21. Contraindications to lumbar puncture.
研究者
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