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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 45

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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