Secondary progressive multiple sclerosis and primary progressive multiple sclerosis MedDRA version: 12.0 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis MedDRA version: 12.0 Level: LLT Classification code 10063401 Term: Primary progressive multiple sclerosis
Conditions
Interventions
Trade Name: Tysabri
Product Name: Natalizumab
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Current Sponsor code: Natalizumab
Other descriptive nam
Sponsors
Dansk Multipel Sclerose Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age between 19 and 55 years Progressive disease course of multiple sclerosis (primary or secondary) Duration of progressive phase of at least 1 year Progression of > 1 EDSS point during the last 2 years (>½ EDSS point if EDSS > 5,5) EDSS =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy, breast-feeding or lack of anti.conception for fertile women. Attack during the last month before inclusion. Treatment with methylprednisolon during 3 months before inclusion. Treatment with interferon-beta, glatirameracetate, immunoglobulin G or other immune-modulating treatment 3 months prior to inclusion. Treatment with mitoxantrone, cyclophosphamide, azatriprine or other strong immunosuppressive drug 6 months prior to inclusion. Prior experimental treatment with strong immunosuppressive drug which the treating physician means will influence the results of the trial. Diseases assiociated with immunedeficiency. Treatment with other anticoagulant than aspirin. Current malign disease. Diabetes mellitus or other autoimmune disease. Renal insuffiency or creatinine > 150 µmol/l. Travel in tropical areas 3 months prior to inclusion. Acute or chronic infectious diseases, which the treating physician finds relevant (e.g. hepatitis B virus, hepatitis C virus, HIV ). Psychiatric disease or other circumstances that may limit the patients participation in the trial. Contraindication for MRI scan or gadolinium contrast .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 exmination, blood samples and MRI measures of disease activity.;Secondary Objective: Clinical: Change in expanded disability status scale (EDSS), Timed 25-foot Walk. (T25FW). Inflammation and disease activity: Change in cellcounts in CSF, intrathecal IgG synthesis, CSF- serum albumin concentration quotient, CXCL13 og nitrogen oxid metabolits i CSF . Numbers of new gadolinium-enhancing lesions (GdEL) on T1-weighted MR images. Volume of lesions on T2-weighted MR images. Numbers of new or enlarging lesions on T2-weighted MR images. Neurodegeneration og demyelination: Change in neurofilament heavy chain and myelin basisk protein in CSF Change in normalised brainvolume, grey matter volume and white matter volume Change in magnetization transfer ratio (MTR) in whole brain, grey matter and normal appearing white matter;Primary end point(s): The primary endpoint is change in CSF osteopontin from baseline (week 0) to week 60. CSF osteopontin will be meassured by the ELISA technique. This endpoint is chosen because conventional endpoints for inflammatory activity in multiple sclerosis trials (GdEL) do not reflect the diffuse inflammation seen in progressive multiple sclerosis. | — |
Countries
Denmark
Outcome results
None listed