Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Copenhagen University Hospital, Rigshospitalet
With
Copenhagen University Hospital, Hvidovre
Biogen
University of Copenhagen
Signifikans ApS
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.
Age
19–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 \</= 6.5
Written and informed consent
You may not be if
Pregnancy, breast-feeding or lack of anti.conception for fertile women.
Attack during the last month before inclusion.
Treatment with methylprednisolone 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, azathioprine 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 associated with immunodeficiency.
Treatment with other anticoagulant than aspirin.
Current malign disease.
Diabetes Mellitus or other autoimmune disease.
Renal insufficiency 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 .
Known hypersensitivity to natalizumab.
Clareo Health | Natalizumab Treatment of Progressive Multiple Sclerosis
