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.
Study Type
OBSERVATIONAL
Enrollment
204
2000mg intravenous methyl prednisolone per day for five consecutive days
6 courses of tryptophane-based immunoadsorption within up to 12 days
Department of Neurology with Institute of Translational Neurology, University Hospital Muenster
Münster, North Rhine-Westphalia, Germany
Expanded disability status scale (EDSS)
Improvement of disability compared to peak relapse EDSS following escalation treatment compared to peark relapse values
Time frame: 2 weeks
visual-evoked potentials (VEP; P100-latency)
Evolution of VEP P100-latency compared to peak relapse values
Time frame: 2 weeks; 6 to 8 weeks
somatosensory-evoked potentials (SEP; Medianus and Tibialis; N20-, P40-latency)
Evolution of SEP N20-/P40-latency compared to peak relapse values
Time frame: 2 weeks; 6 to 8 weeks
best-corrected visual acuity (bcVA)
Evolution of bcVA compared to peak relapse values
Time frame: 2 weeks; 6 to 8 weeks
Expanded disability status scale (EDSS)
Confirmation of improvement of disability compared to primary endpoint
Time frame: 6 to 8 weeks
Multiple scleroris functional compositie (MSFC)
Development of MSFC z-score compared to peak relapse values
Time frame: 2 weeks, 6 to 8 weeks
Short form-36 questionaire (SF-36)
Development of quality-of-life compared to peak relapse values
Time frame: 6 to 8 weeks
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