EUCTR2012-004436-36-DK
Active, not recruiting
Phase 1
A prospective pilotstudy of immunological and radiological effects of intrathecal rituximab in patients with secondary progressive multiple sclerosis
DrugsMabThera (Rituximab)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Odense University Hospital
- Enrollment
- 15
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical definate multiple sclerosis
- •Secondary progressive multiple sclerosis defines as no relaps within 1 year, and sustained progression more than 3 month
- •Disease duration \>15 years
- •EDSS score 3\-7 (both included)
- •No contrast enhancement on MRI
- •Presence of oligoclonal bands and increased intrathechal IgG index
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 15
Exclusion Criteria
- •Pregnancy and lactation
- •Positive anti\-JC virus antibody
- •Treatment with Natalizumab within 6 month
- •Treatment with interferon\-beta or glatiramer acetate within 3 month
- •Prior treatment with immunosupressant
- •Decreased leucocyte or platelet count
- •Decreased liver or kidneyfunction
- •B\-cell deficiency (low IgA, IgG or IgM)
- •Implanted metal or devices that contraindicates MRI
Outcomes
Primary Outcomes
Not specified
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