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

University Hospital Muenster

Status: Unknown

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Procedure: Immunoadsorption; Drug: Methyl Prednisolonate

Study type: Observational

Funder types: Other

Identifiers

NCT04450030

INCIDENTMS2018

Details and patient eligibility

About

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.

Enrollment: 204 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

204 participants in 2 patient groups

Intravenous methyl prednisolone

Description:

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

Treatment:

Drug: Methyl Prednisolonate

Immunoadsorption

Description:

Patients receiving 6 courses of immunadsorption treatment for treatment of a steroid-refractory MS relapse

Treatment:

Procedure: Immunoadsorption