Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: Methyl Prednisolonate; Procedure: Immunoadsorption

• Registration Number: NCT04450030
• Lead Sponsor: University Hospital Muenster

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-29
• Primary Completion: 2020-09-05
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-12
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intravenous methyl prednisolone	Methyl Prednisolonate	Patients receiving an additional course of intravenous methyl prednisolone for treatment of a steroid-refractory MS relapse
Immunoadsorption	Immunoadsorption	Patients receiving 6 courses of immunadsorption treatment for treatment of a steroid-refractory MS relapse

Primary Outcome Measures

Name	Time	Method
Expanded disability status scale (EDSS)	2 weeks	Improvement of disability compared to peak relapse EDSS following escalation treatment compared to peark relapse values

Secondary Outcome Measures

Name	Time	Method
Multiple scleroris functional compositie (MSFC)	2 weeks, 6 to 8 weeks	Development of MSFC z-score 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
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
Expanded disability status scale (EDSS)	6 to 8 weeks	Confirmation of improvement of disability compared to primary endpoint
Short form-36 questionaire (SF-36)	6 to 8 weeks	Development of quality-of-life compared to peak relapse values

Trial Locations

Locations (1)

Department of Neurology with Institute of Translational Neurology, University Hospital Muenster; 🇩🇪 Muenster, Northrhine-Westphalia, Germany