INCIDENT-MS
What it found
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 repairsomatosensory-evoked potentials (SEP; Medianus and Tibialis; N20-, P40-latency)
2 weeks; 6 to 8 weeks
RelapsesMyelin repairbest-corrected visual acuity (bcVA)
2 weeks; 6 to 8 weeks
RelapsesVisionExpanded disability status scale (EDSS)
6 to 8 weeks
Disability progressionMultiple scleroris functional compositie (MSFC)
2 weeks, 6 to 8 weeks
Disability progressionRelapsesShort 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
Loading reviews and guidelines…
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History
Started
Aug 2018
Main results due
Sept 2020
Finished
Dec 2020
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