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Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis

Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis

Recruiting
18-65 years
All
Phase N/A

Overview

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.

Eligibility

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

Study details
    relapsing-remitting multiple sclerosis

NCT04450030

University Hospital Muenster

5 August 2020

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