Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis

NCT04450030 | Unknown FDA Drug

• 1 other identifier: INCIDENTMS2018
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

immunoadsorption; intravenous methyl prednisolone

Outcome Measures

Primary Outcomes (1)

• Expanded disability status scale (EDSS)

  Improvement of disability compared to peak relapse EDSS following escalation treatment compared to peark relapse values

  2 weeks

Secondary Outcomes (6)

• visual-evoked potentials (VEP; P100-latency)

  2 weeks; 6 to 8 weeks

• somatosensory-evoked potentials (SEP; Medianus and Tibialis; N20-, P40-latency)

  2 weeks; 6 to 8 weeks

• best-corrected visual acuity (bcVA)

  2 weeks; 6 to 8 weeks

• Expanded disability status scale (EDSS)

  6 to 8 weeks

• Multiple scleroris functional compositie (MSFC)

  2 weeks, 6 to 8 weeks

Study Arms (2)

Intravenous methyl prednisolone

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

Drug: Methyl Prednisolonate

Immunoadsorption

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

Procedure: Immunoadsorption

Interventions

Methyl Prednisolonate DRUG

2000mg intravenous methyl prednisolone per day for five consecutive days

Intravenous methyl prednisolone

Immunoadsorption PROCEDURE

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

Immunoadsorption

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

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

Münster, North Rhine-Westphalia, 48149, Germany

Location

Related Publications (1)

• 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.

  PMID: 36071461 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

methyl prednisolonate; Plasmapheresis

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Sven G Meuth, Prof Dr

  University Hospital Muenster, Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 29, 2020
• Study Start: August 1, 2018
• Primary Completion: September 5, 2020
• Study Completion: December 31, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)