Clinical trial NCT04450030: Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis
Official title: Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis - Assessment of Mechanism of Action
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: immunoadsorption
intravenous methyl prednisolone
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute relapsing multiple sclerosis that were refractory to a first course of intravenous methyl prednisolone (1000mg per day for three to five consecutive days)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Expanded disability status scale (EDSS)
timeFrame: 2 weeks
Secondary outcomes:
measure: visual-evoked potentials (VEP; P100-latency)
timeFrame: 2 weeks; 6 to 8 weeks
measure: somatosensory-evoked potentials (SEP; Medianus and Tibialis; N20-, P40-latency)
timeFrame: 2 weeks; 6 to 8 weeks
measure: best-corrected visual acuity (bcVA)
timeFrame: 2 weeks; 6 to 8 weeks
measure: Expanded disability status scale (EDSS)
timeFrame: 6 to 8 weeks
measure: Multiple scleroris functional compositie (MSFC)
timeFrame: 2 weeks, 6 to 8 weeks
measure: Short form-36 questionaire (SF-36)
timeFrame: 6 to 8 weeks
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Neurology with Institute of Translational Neurology, University Hospital Muenster
state: Northrhine-Westphalia
Study officials:
affiliation: University Hospital Muenster, Department of Neurology
name: Sven G Meuth, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pfeuffer S, Rolfes L, Wirth T, Steffen F, Pawlitzki M, Schulte-Mecklenbeck A, Gross CC, Brand M, Bittner S, Ruck T, Klotz L, Wiendl H, Meuth SG. Immunoadsorption versus double-dose methylprednisolone in refractory multiple sclerosis relapses. J Neuroinflammation. 2022 Sep 7;19(1):220. doi: 10.1186/s12974-022-02583-y.