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Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis

NCT ID: NCT04450030

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Keywords

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immunoadsorption intravenous methyl prednisolone

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intravenous methyl prednisolone

Patients receiving an additional course of intravenous methyl prednisolone for treatment of a steroid-refractory MS relapse

Methyl Prednisolonate

Intervention Type DRUG

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

Immunoadsorption

Intervention Type PROCEDURE

6 courses of tryptophane-based immunoadsorption within up to 12 days

Interventions

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Methyl Prednisolonate

2000mg intravenous methyl prednisolone per day for five consecutive days

Intervention Type DRUG

Immunoadsorption

6 courses of tryptophane-based immunoadsorption within up to 12 days

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sven G Meuth, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital Muenster, Department of Neurology

Locations

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Department of Neurology with Institute of Translational Neurology, University Hospital Muenster

Münster, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 36071461 (View on PubMed)

Other Identifiers

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INCIDENTMS2018

Identifier Type: -

Identifier Source: org_study_id