<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04450030</url>
  </required_header>
  <id_info>
    <org_study_id>INCIDENTMS2018</org_study_id>
    <nct_id>NCT04450030</nct_id>
  </id_info>
  <brief_title>Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis</brief_title>
  <acronym>INCIDENT-MS</acronym>
  <official_title>Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis - Assessment of Mechanism of Action</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Muenster</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Muenster</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Treatment of acute relapsing multiple sclerosis (MS) has remained largely unaltered within&#xD;
      past years. However, evidence defining the exact role of apheresis treatment in the&#xD;
      therapeutic sequence is still incomplete. INCIDENT-MS evaluates the mechanism of action of&#xD;
      immunoadsorption compared to escalated methyl prednisolone treatment in steroid-refractory MS&#xD;
      relapses and thereby will help to identify predictive markers for optimal treatment choice&#xD;
      and will generate further insights into the pathophysiology of MS relapses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">September 5, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Expanded disability status scale (EDSS)</measure>
    <time_frame>2 weeks</time_frame>
    <description>Improvement of disability compared to peak relapse EDSS following escalation treatment compared to peark relapse values</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>visual-evoked potentials (VEP; P100-latency)</measure>
    <time_frame>2 weeks; 6 to 8 weeks</time_frame>
    <description>Evolution of VEP P100-latency compared to peak relapse values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>somatosensory-evoked potentials (SEP; Medianus and Tibialis; N20-, P40-latency)</measure>
    <time_frame>2 weeks; 6 to 8 weeks</time_frame>
    <description>Evolution of SEP N20-/P40-latency compared to peak relapse values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>best-corrected visual acuity (bcVA)</measure>
    <time_frame>2 weeks; 6 to 8 weeks</time_frame>
    <description>Evolution of bcVA compared to peak relapse values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expanded disability status scale (EDSS)</measure>
    <time_frame>6 to 8 weeks</time_frame>
    <description>Confirmation of improvement of disability compared to primary endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple scleroris functional compositie (MSFC)</measure>
    <time_frame>2 weeks, 6 to 8 weeks</time_frame>
    <description>Development of MSFC z-score compared to peak relapse values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short form-36 questionaire (SF-36)</measure>
    <time_frame>6 to 8 weeks</time_frame>
    <description>Development of quality-of-life compared to peak relapse values</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">204</enrollment>
  <condition>Multiple Sclerosis, Relapsing-Remitting</condition>
  <arm_group>
    <arm_group_label>Intravenous methyl prednisolone</arm_group_label>
    <description>Patients receiving an additional course of intravenous methyl prednisolone for treatment of a steroid-refractory MS relapse</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immunoadsorption</arm_group_label>
    <description>Patients receiving 6 courses of immunadsorption treatment for treatment of a steroid-refractory MS relapse</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methyl Prednisolonate</intervention_name>
    <description>2000mg intravenous methyl prednisolone per day for five consecutive days</description>
    <arm_group_label>Intravenous methyl prednisolone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Immunoadsorption</intervention_name>
    <description>6 courses of tryptophane-based immunoadsorption within up to 12 days</description>
    <arm_group_label>Immunoadsorption</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute relapsing multiple sclerosis that were refractory to a first course of&#xD;
        intravenous methyl prednisolone (1000mg per day for three to five consecutive days)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
          -  Diagnosis of relapsing-remitting multiple sclerosis according to 2017 revised&#xD;
             McDonald-criteria&#xD;
&#xD;
          -  Incomplete remission of relapse symptoms following initiation treatment with 1000mg/d&#xD;
             intravenous methyl prednisolone&#xD;
&#xD;
          -  Absence of fever or clinically apparent signs of infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Baseline EDSS score &gt;6.5 points&#xD;
&#xD;
          -  Previous administration of less than 3x1000mg or more than 5x1000mg IVMPS for&#xD;
             initiation treatment&#xD;
&#xD;
          -  Known pregnancy or rejection to perform a pregnancy test (female patients only)&#xD;
&#xD;
          -  Immunosuppressive treatment for conditions other than multiple sclerosis&#xD;
&#xD;
          -  Ongoing neoplastic disorder or past neoplastic disorder within previous five years&#xD;
&#xD;
          -  Known or newly diagnosed HIV-, HBV- or HCV-infection&#xD;
&#xD;
          -  Regular intake of ACE inhibitor drugs&#xD;
&#xD;
          -  Known bleeding disorders (including laboratory abnormalities such as: (I) platelet&#xD;
             count&lt;50.000/µL; (II) international normalized ratio&gt;1.5, (III) activated prothrombin&#xD;
             time&gt;50s) or intake of oral anticoagulant drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sven G Meuth, Prof Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Muenster, Department of Neurology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Neurology with Institute of Translational Neurology, University Hospital Muenster</name>
      <address>
        <city>Muenster</city>
        <state>Northrhine-Westphalia</state>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>November 10, 2020</last_update_submitted>
  <last_update_submitted_qc>November 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>immunoadsorption</keyword>
  <keyword>intravenous methyl prednisolone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Multiple Sclerosis, Relapsing-Remitting</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04450030
org study id: INCIDENTMS2018
nct id: NCT04450030
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
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.
observational model: Cohort
time perspective: Prospective
measure: Expanded disability status scale (EDSS)
time frame: 2 weeks
description: Improvement of disability compared to peak relapse EDSS following escalation treatment compared to peark relapse values
measure: visual-evoked potentials (VEP; P100-latency)
time frame: 2 weeks; 6 to 8 weeks
description: Evolution of VEP P100-latency compared to peak relapse values
measure: somatosensory-evoked potentials (SEP; Medianus and Tibialis; N20-, P40-latency)
time frame: 2 weeks; 6 to 8 weeks
description: Evolution of SEP N20-/P40-latency compared to peak relapse values
measure: best-corrected visual acuity (bcVA)
time frame: 2 weeks; 6 to 8 weeks
description: Evolution of bcVA compared to peak relapse values
measure: Expanded disability status scale (EDSS)
time frame: 6 to 8 weeks
description: Confirmation of improvement of disability compared to primary endpoint
measure: Multiple scleroris functional compositie (MSFC)
time frame: 2 weeks, 6 to 8 weeks
description: Development of MSFC z-score compared to peak relapse values
measure: Short form-36 questionaire (SF-36)
time frame: 6 to 8 weeks
description: Development of quality-of-life compared to peak relapse values
arm group label: Intravenous methyl prednisolone
description: Patients receiving an additional course of intravenous methyl prednisolone for treatment of a steroid-refractory MS relapse
arm group label: Immunoadsorption
description: Patients receiving 6 courses of immunadsorption treatment for treatment of a steroid-refractory MS relapse
intervention type: Drug
intervention name: Methyl Prednisolonate
description: 2000mg intravenous methyl prednisolone per day for five consecutive days
arm group label: Intravenous methyl prednisolone
intervention type: Procedure
intervention name: Immunoadsorption
description: 6 courses of tryptophane-based immunoadsorption within up to 12 days
arm group label: Immunoadsorption
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sven G Meuth, Prof Dr
role: Principal Investigator
affiliation: University Hospital Muenster, Department of Neurology
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Sclerosis
sharing ipd: No