Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis

GlaxoSmithKline Research & Development Ltd0 sites350 target enrollmentAugust 10, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline Research & Development Ltd
Enrollment: 350
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 10, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Research & Development Ltd

Eligibility Criteria

Inclusion Criteria

•1\.Written informed consent
•2\.Males or females, aged 18 to 65, inclusive
•3\.Diagnosis of RRMS with dissemination in time and space
•4\.EDSS of between 0 and 6\.0 inclusive at the Screening visit
•5\.Occurrence of at least two relapses in previous 24 months with at least 1 relapse or documented evidence of gadolinium\-enhancement on MRI (prior to screening) in the previous 12 months. Subject must not have had a relapse within 4 weeks prior to Screening.
•6\.Minimum of five T2 lesions on brain MRI at Visit 2 as determined by the central MRI analysis reader
•7\.A female subject is eligible to enter the study if she is of non\-childbearing potential or has a negative urine pregnancy test at Screening, and agrees to the consistent and correct use of agreed methods of contraception.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

•1\.Subjects receiving corticosteroids within 4 weeks of Screening for treatment of MS. If non\-systemic steroids are being used for other chronic inflammatory conditions, subjects may be included at the discretion of the investigator after discussion with the GSK medical monitor
•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. Subjects who have received other therapies affecting the immune system (such as intravenous immunoglobulin (IVIg), cyclophosphamide, plasmapheresis, or any other immunosuppressive or immunomodulatory treatment) in the past may be included on a case by case basis after discussion with the GSK medical monitor. None of these treatments will be allowed during this study
•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 (including known allergy to gadolinium)
•5\.Use of 4\-aminopyridine, rosiglitazone, pioglitazone or any drug that is an inhibitor of or a substrate (with a low therapeutic index) for OATP at Screening.
•6\.Patients with clinically significant renal laboratory values: subjects with a calculated creatinine clearance \<60ml/min (by Cockcroft and Gault) at Screening
•7\.Presence of clinically significant hepatic laboratory values: ALT, AST, GGT \> 2\.0\- times the upper limit of normal (ULN); total bilirubin \> 1\.5 times the ULN at Screening
•8\.CD4 count \<500, CD4:CD8 \<1\.0, JC viremia detected in plasma or white cells, idiopathic CD4/CD8 lymphopenia or secondary lymphopenia at Screening
•9\.Any findings on the MRI of the brain at Visit 2 other than MS, except for benign findings that (in the opinion of the central MRI reading site and local site investigator) require no further evaluation or treatment and do not impact patient's neurological health (e.g., small arachnoid cysts, venous angiomas)
•10\.Current or history of cancer, excluding localized non\-melanoma skin cancer