Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis (INCIDENT-MS)

Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis - Assessment of Mechanism of Action

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 Overview

• Status: Unknown
• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Intervention / Treatment: Drug: Methyl Prednisolonate; Procedure: Immunoadsorption

• Study Type: Observational
• Enrollment (Anticipated): 204

Contacts and Locations

Study Locations

• Germany
  • Northrhine-Westphalia
    • Muenster, Northrhine-Westphalia, Germany, 48149
      • Department of Neurology with Institute of Translational Neurology, University Hospital Muenster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intravenous methyl prednisolone; Patients receiving an additional course of intravenous methyl prednisolone for treatment of a steroid-refractory MS relapse	Drug: Methyl Prednisolonate; 2000mg intravenous methyl prednisolone per day for five consecutive days
Immunoadsorption; Patients receiving 6 courses of immunadsorption treatment for treatment of a steroid-refractory MS relapse	Procedure: Immunoadsorption; 6 courses of tryptophane-based immunoadsorption within up to 12 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expanded disability status scale (EDSS)	Improvement of disability compared to peak relapse EDSS following escalation treatment compared to peark relapse values	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual-evoked potentials (VEP; P100-latency)	Evolution of VEP P100-latency compared to peak relapse values	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	2 weeks; 6 to 8 weeks
best-corrected visual acuity (bcVA)	Evolution of bcVA compared to peak relapse values	2 weeks; 6 to 8 weeks
Expanded disability status scale (EDSS)	Confirmation of improvement of disability compared to primary endpoint	6 to 8 weeks
Multiple scleroris functional compositie (MSFC)	Development of MSFC z-score compared to peak relapse values	2 weeks, 6 to 8 weeks
Short form-36 questionaire (SF-36)	Development of quality-of-life compared to peak relapse values	6 to 8 weeks

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Investigators: Principal Investigator: Sven G Meuth, Prof Dr, University Hospital Muenster, Department of Neurology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): September 5, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (ACTUAL): June 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: immunoadsorption; intravenous methyl prednisolone
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: INCIDENTMS2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No