Status:

UNKNOWN

Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis

Lead Sponsor:

University Hospital Muenster

Conditions:

Multiple Sclerosis, Relapsing-Remitting

Eligibility:

All Genders

18-65 years

Brief Summary

Treatment of acute relapsing multiple sclerosis (MS) has remained largely unaltered within past years. However, evidence defining the exact role of apheresis treatment in the therapeutic sequence is s...

Eligibility Criteria

Inclusion

  • Signed informed consent form
  • Diagnosis of relapsing-remitting multiple sclerosis according to 2017 revised McDonald-criteria
  • Incomplete remission of relapse symptoms following initiation treatment with 1000mg/d intravenous methyl prednisolone
  • Absence of fever or clinically apparent signs of infection

Exclusion

  • Baseline EDSS score \>6.5 points
  • Previous administration of less than 3x1000mg or more than 5x1000mg IVMPS for initiation treatment
  • Known pregnancy or rejection to perform a pregnancy test (female patients only)
  • Immunosuppressive treatment for conditions other than multiple sclerosis
  • Ongoing neoplastic disorder or past neoplastic disorder within previous five years
  • Known or newly diagnosed HIV-, HBV- or HCV-infection
  • Regular intake of ACE inhibitor drugs
  • Known bleeding disorders (including laboratory abnormalities such as: (I) platelet count\<50.000/µL; (II) international normalized ratio\>1.5, (III) activated prothrombin time\>50s) or intake of oral anticoagulant drugs

Key Trial Info

Start Date :

August 1 2018

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2020

Estimated Enrollment :

204 Patients enrolled

Trial Details

Trial ID

NCT04450030

Start Date

August 1 2018

End Date

December 31 2020

Last Update

November 12 2020

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Department of Neurology with Institute of Translational Neurology, University Hospital Muenster

Münster, North Rhine-Westphalia, Germany, 48149

Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis | DecenTrialz