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| Name | Class |
|---|---|
| Copenhagen University Hospital, Hvidovre | OTHER |
| Biogen | INDUSTRY |
| University of Copenhagen | OTHER |
| Signifikans ApS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natalizumab | Experimental | 24 patients: 12 with secondary progressive multiple sclerosis 12 with primary progressive multiple sclerosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natalizumab | Drug | 300 mg Natalizumab IV for every 4 week for 56 weeks (15 doses for every patient) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebrospinal fluid (CSF) osteopontin | The primary endpoint is change in CSF osteopontin from baseline to week 60. | Change from baseline to week 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Expanded disability status scale (EDSS) | Change in expanded disability status scale (EDSS)from baseline to week 60 | Baseline to week 60 |
| Timed 25-foot Walk (T25FW) | Baseline to week 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Finn Sellebjerg, MD PhD DMSc | Danish Multiple Sclerosis Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Multiple Sclerosis Center, Section 2082, Rigshospitalet | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| OTHER |
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| Multiple Sclerosis Impairment Score (MSIS) | Baseline to week 60 |
| Multiple Sclerosis Functional Composite | Baseline to week 60 |
| Short Form 36 Health Survey (SF36) | Baseline to week 60 |
| CSF Neurofilament Heavy Chain | Change in neurofilament heavy chain in the cerebrospinal fluid | Baseline to week 60 |
| CSF Myelin Basic Protein | Change in myelin basic protein in CSF from baseline to week 60 | 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 | Week 12 to week 60 |
| Magnetization transfer ratio (MTR) | Change in MTR in whole brain, lesions, normal-appearing grey matter (NAGM) og normal-appearing white matter (NAWM) from baseline to week 60 | Baseline to week 60 |
| Diffusion transfer imaging (DTI) | Change in FA and ADC in lesions, GM and NAWM between baseline and week 60. | Baseline to week 60 |
| CSF cell count | Change in CSF cell count from baseline to week 60 | Baseline to week 60 |
| Change in IgG-index | Baseline to week 60 |
| CSF nitrogen oxide metabolites | Baseline to week 60 |
| CSF-serum albumine concentration quotient | Baseline to week 60 |
| CSF CXCL13 | Baseline to week 60 |
| Matrix metalloproteinase-9 (MMP-9) | Baseline to week 60 |
| New Gadolinium-enhancing lesions (GdEL) | Baseline to week 60 |
| Volume of lesions on T2-weighted MRI images | Baseline to week 60 |
| Number of new or enlarging lesions on T2-weighted MRI images | Baseline to week 60 |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |