Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
immunoadsorption, intravenous methyl prednisolone
Brief 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.
Interventions
2000mg intravenous methyl prednisolone per day for five consecutive days
PROCEDUREImmunoadsorption
6 courses of tryptophane-based immunoadsorption within up to 12 days
Sponsors
University Hospital Muenster
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expanded disability status scale (EDSS) | 2 weeks | Improvement of disability compared to peak relapse EDSS following escalation treatment compared to peark relapse values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| somatosensory-evoked potentials (SEP; Medianus and Tibialis; N20-, P40-latency) | 2 weeks; 6 to 8 weeks | Evolution of SEP N20-/P40-latency compared to peak relapse values |
| best-corrected visual acuity (bcVA) | 2 weeks; 6 to 8 weeks | Evolution of bcVA compared to peak relapse values |
| visual-evoked potentials (VEP; P100-latency) | 2 weeks; 6 to 8 weeks | Evolution of VEP P100-latency compared to peak relapse values |
| Multiple scleroris functional compositie (MSFC) | 2 weeks, 6 to 8 weeks | Development of MSFC z-score compared to peak relapse values |
| Short form-36 questionaire (SF-36) | 6 to 8 weeks | Development of quality-of-life compared to peak relapse values |
| Expanded disability status scale (EDSS) | 6 to 8 weeks | Confirmation of improvement of disability compared to primary endpoint |
Countries
Germany
Outcome results
None listed