Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— INCIDENT-MS  

Official title:

Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis - Assessment of Mechanism of Action

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04450030
• Other study ID #: INCIDENTMS2018
• Status: Active, not recruiting
• Start date: August 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2020
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 204
• Est. completion date: December 31, 2020
• Est. primary completion date: September 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Methyl Prednisolonate
2000mg intravenous methyl prednisolone per day for five consecutive days

Procedure:
• Immunoadsorption
6 courses of tryptophane-based immunoadsorption within up to 12 days

Locations

Country	Name	City	State
Germany	Department of Neurology with Institute of Translational Neurology, University Hospital Muenster	Muenster	Northrhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expanded disability status scale (EDSS)	Improvement of disability compared to peak relapse EDSS following escalation treatment compared to peark relapse values	2 weeks
Secondary	visual-evoked potentials (VEP; P100-latency)	Evolution of VEP P100-latency compared to peak relapse values	2 weeks; 6 to 8 weeks
Secondary	somatosensory-evoked potentials (SEP; Medianus and Tibialis; N20-, P40-latency)	Evolution of SEP N20-/P40-latency compared to peak relapse values	2 weeks; 6 to 8 weeks
Secondary	best-corrected visual acuity (bcVA)	Evolution of bcVA compared to peak relapse values	2 weeks; 6 to 8 weeks
Secondary	Expanded disability status scale (EDSS)	Confirmation of improvement of disability compared to primary endpoint	6 to 8 weeks
Secondary	Multiple scleroris functional compositie (MSFC)	Development of MSFC z-score compared to peak relapse values	2 weeks, 6 to 8 weeks
Secondary	Short form-36 questionaire (SF-36)	Development of quality-of-life compared to peak relapse values	6 to 8 weeks