Status unknownRelapsing MSNCT04450030

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Methyl Prednisolonate
  • Immunoadsorption

What it measured

Main measures

  • Expanded disability status scale (EDSS)

    2 weeks

    Disability progressionRelapses

Other measures (6)

  • visual-evoked potentials (VEP; P100-latency)

    2 weeks; 6 to 8 weeks

    RelapsesMyelin repair
  • somatosensory-evoked potentials (SEP; Medianus and Tibialis; N20-, P40-latency)

    2 weeks; 6 to 8 weeks

    RelapsesMyelin repair
  • best-corrected visual acuity (bcVA)

    2 weeks; 6 to 8 weeks

    RelapsesVision
  • Expanded disability status scale (EDSS)

    6 to 8 weeks

    Disability progression
  • Multiple scleroris functional compositie (MSFC)

    2 weeks, 6 to 8 weeks

    Disability progressionRelapses
  • Short form-36 questionaire (SF-36)

    6 to 8 weeks

    RelapsesQuality of life (reported by participants)

Who could take part

Relapsing MS · 18 to 65

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      Aug 2018

    2. Main results due

      Sept 2020

    3. Finished

      Dec 2020

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