Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04450030
Recruitment Status : Active, not recruiting
First Posted : June 29, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Multiple Sclerosis, Relapsing-Remitting Drug: Methyl Prednisolonate Procedure: Immunoadsorption

Layout table for study information
Study Type : Observational
Estimated Enrollment : 204 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis - Assessment of Mechanism of Action
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : September 5, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Expanded disability status scale (EDSS) [ Time Frame: 2 weeks ]
    Improvement of disability compared to peak relapse EDSS following escalation treatment compared to peark relapse values


Secondary Outcome Measures :
  1. visual-evoked potentials (VEP; P100-latency) [ Time Frame: 2 weeks; 6 to 8 weeks ]
    Evolution of VEP P100-latency compared to peak relapse values

  2. somatosensory-evoked potentials (SEP; Medianus and Tibialis; N20-, P40-latency) [ Time Frame: 2 weeks; 6 to 8 weeks ]
    Evolution of SEP N20-/P40-latency compared to peak relapse values

  3. best-corrected visual acuity (bcVA) [ Time Frame: 2 weeks; 6 to 8 weeks ]
    Evolution of bcVA compared to peak relapse values

  4. Expanded disability status scale (EDSS) [ Time Frame: 6 to 8 weeks ]
    Confirmation of improvement of disability compared to primary endpoint

  5. Multiple scleroris functional compositie (MSFC) [ Time Frame: 2 weeks, 6 to 8 weeks ]
    Development of MSFC z-score compared to peak relapse values

  6. Short form-36 questionaire (SF-36) [ Time Frame: 6 to 8 weeks ]
    Development of quality-of-life compared to peak relapse values



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450030


Locations
Layout table for location information
Germany
Department of Neurology with Institute of Translational Neurology, University Hospital Muenster
Muenster, Northrhine-Westphalia, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
Layout table for investigator information
Principal Investigator: Sven G Meuth, Prof Dr University Hospital Muenster, Department of Neurology
Layout table for additonal information
Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT04450030    
Other Study ID Numbers: INCIDENTMS2018
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by University Hospital Muenster:
immunoadsorption
intravenous methyl prednisolone
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases