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Clinical Trials/EUCTR2012-004436-36-DK
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

Odense University Hospital0 sites15 target enrollmentApril 22, 2013

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.

Registry
who.int
Start Date
April 22, 2013
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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