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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous methyl prednisolone | Patients receiving an additional course of intravenous methyl prednisolone for treatment of a steroid-refractory MS relapse |
| |
| Immunoadsorption | Patients receiving 6 courses of immunadsorption treatment for treatment of a steroid-refractory MS relapse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methyl Prednisolonate | Drug | 2000mg intravenous methyl prednisolone per day for five consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Expanded disability status scale (EDSS) | Improvement of disability compared to peak relapse EDSS following escalation treatment compared to peark relapse values | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| visual-evoked potentials (VEP; P100-latency) | Evolution of VEP P100-latency compared to peak relapse values | 2 weeks; 6 to 8 weeks |
| somatosensory-evoked potentials (SEP; Medianus and Tibialis; N20-, P40-latency) |
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Inclusion Criteria:
Exclusion Criteria:
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Sven G Meuth, Prof Dr | University Hospital Muenster, Department of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology with Institute of Translational Neurology, University Hospital Muenster | Münster | North Rhine-Westphalia | 48149 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36071461 | Derived | 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. |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C025429 | methyl prednisolonate |
| D010956 | Plasmapheresis |
| ID | Term |
|---|---|
| D001781 | Blood Component Removal |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
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| Immunoadsorption | Procedure | 6 courses of tryptophane-based immunoadsorption within up to 12 days |
|
Evolution of SEP N20-/P40-latency compared to peak relapse values
| 2 weeks; 6 to 8 weeks |
| best-corrected visual acuity (bcVA) | Evolution of bcVA compared to peak relapse values | 2 weeks; 6 to 8 weeks |
| Expanded disability status scale (EDSS) | Confirmation of improvement of disability compared to primary endpoint | 6 to 8 weeks |
| Multiple scleroris functional compositie (MSFC) | Development of MSFC z-score compared to peak relapse values | 2 weeks, 6 to 8 weeks |
| Short form-36 questionaire (SF-36) | Development of quality-of-life compared to peak relapse values | 6 to 8 weeks |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013514 | Surgical Procedures, Operative |