The purpose of this study is to study safety and efficacy of natalizumab treatment of primary and secondary progressive multiple sclerosis. This will be done by measuring the effect of treatment on inflammation in the CNS by means of osteopontin levels in the cerebrospinal fluid (CSF). Safety measures further includes physical and neurological examination,blood samples and MRI measures of disease activity.
The study will include 12 secondary progressive multiple sclerosis patients and 12 primary progressive multiple sclerosis patients to treatment with IV natalizumab for 60 weeks. At baseline and week 60 a lumbar puncture will be performed. MRI scans will be performed at baseline week 12 and week 60.Safety blood samples will be collected every 12 week.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
300 mg Natalizumab IV for every 4 week for 56 weeks (15 doses for every patient)
Danish Multiple Sclerosis Center, Section 2082, Rigshospitalet
Copenhagen, Denmark
Cerebrospinal fluid (CSF) osteopontin
The primary endpoint is change in CSF osteopontin from baseline to week 60.
Time frame: Change from baseline to week 60
Expanded disability status scale (EDSS)
Change in expanded disability status scale (EDSS)from baseline to week 60
Time frame: Baseline to week 60
Timed 25-foot Walk (T25FW)
Time frame: Baseline to week 60
Multiple Sclerosis Impairment Score (MSIS)
Time frame: Baseline to week 60
Multiple Sclerosis Functional Composite
Time frame: Baseline to week 60
Short Form 36 Health Survey (SF36)
Time frame: Baseline to week 60
CSF Neurofilament Heavy Chain
Change in neurofilament heavy chain in the cerebrospinal fluid
Time frame: Baseline to week 60
CSF Myelin Basic Protein
Change in myelin basic protein in CSF from baseline to week 60
Time frame: Baseline to week 60
Atrophy
Change in normalised brain volume (NBV), grey matter volume (GMV) og white matter volume (WMV) from week 12 to week 60
Time frame: Week 12 to week 60
Magnetization transfer ratio (MTR)
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Change in MTR in whole brain, lesions, normal-appearing grey matter (NAGM) og normal-appearing white matter (NAWM) from baseline to week 60
Time frame: Baseline to week 60
Diffusion transfer imaging (DTI)
Change in FA and ADC in lesions, GM and NAWM between baseline and week 60.
Time frame: Baseline to week 60
CSF cell count
Change in CSF cell count from baseline to week 60
Time frame: Baseline to week 60
Change in IgG-index
Time frame: Baseline to week 60
CSF nitrogen oxide metabolites
Time frame: Baseline to week 60
CSF-serum albumine concentration quotient
Time frame: Baseline to week 60
CSF CXCL13
Time frame: Baseline to week 60
Matrix metalloproteinase-9 (MMP-9)
Time frame: Baseline to week 60
New Gadolinium-enhancing lesions (GdEL)
Time frame: Baseline to week 60
Volume of lesions on T2-weighted MRI images
Time frame: Baseline to week 60
Number of new or enlarging lesions on T2-weighted MRI images
Time frame: Baseline to week 60