Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis

  • STATUS
    Recruiting
  • participants needed
    204
  • sponsor
    University Hospital Muenster
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Updated on 5 August 2020
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remission
corticosteroids
prednisolone
multiple sclerosis
apheresis
relapsing multiple sclerosis

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 still incomplete. INCIDENT-MS evaluates the mechanism of action of immunoadsorption compared to escalated methyl prednisolone treatment in steroid-refractory MS relapses and thereby will help to identify predictive markers for optimal treatment choice and will generate further insights into the pathophysiology of MS relapses.

Details
Condition relapsing-remitting multiple sclerosis
Age 18years - 65years
Treatment Methyl Prednisolonate, Immunoadsorption
Clinical Study IdentifierNCT04450030
SponsorUniversity Hospital Muenster
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

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/L; (II) international normalized ratio>1.5, (III) activated prothrombin time>50s) or intake of oral anticoagulant drugs
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