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This observational study investigates the efficacy and safety of immunoadsorption versus plasmapheresis in 60 patients with relapse in Multiple Sclerosis and Clinically isolated syndrome who do not fully recover after a high doses of intravenous corticosteroids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunoadsorption | Experimental | Immunoadsorption on 5 consecutive days with protein A columns and 2,5-fold patient's plasma volume |
|
| Plasmapheresis | Active Comparator | Plasmapheresis on 5 consecutive days with 2l plasma exchange |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoadsorption | Procedure |
| ||
| Plasmapheresis |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple Sclerosis Functional Composite (MSFC) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Expanded Disability Status Scale (EDSS) | 2 and 4 weeks | |
| EuroQol (EQ5D-5L) | 2 and 4 weeks | |
| Response Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, University of Ulm | Ulm | Baden-Wurttemberg | 89081 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38700322 | Derived | Vardakas I, Dorst J, Huss A, Mayer B, Fangerau T, Taranu D, Tumani H, Senel M. Serum neurofilament light chain and glial fibrillary acidic protein for predicting response to apheresis in steroid-refractory multiple sclerosis relapses. Eur J Neurol. 2024 Aug;31(8):e16323. doi: 10.1111/ene.16323. Epub 2024 May 3. | |
| 31832624 | Derived |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D010956 | Plasmapheresis |
| ID | Term |
|---|---|
| D001781 | Blood Component Removal |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
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|
defined as share of patients who show an improvement of least 10% in MSFC (see Outcome 1) compared to baseline value |
| 4 weeks |
| Vision | defined as percentage of normal vision as measured by visual test according to EDSS standardized testing (see outcome 2) | 4 weeks |
| Visually Evoked Potentials (VEP; P100 latency) | 4 weeks |
| Somatosensory Evoked Potentials (SEP; Medianus and Tibialis; N20-, P40-latency) | 4 weeks |
| Thickness of Retinal Nerve Fiber Layer (RNFL) in Optical Coherence Tomography (OCT) | 4 weeks |
| Verbaler Lern- und Merkfähigkeitstest (VLMT) score | 4 weeks |
| MSFC | 2 weeks |
| Thickness of Ganglion Cell Layer (GCL) in OCT | 4 weeks |
| Symbol Digit Modalities Test (SDMT) score | 4 weeks |
| Dorst J, Fangerau T, Taranu D, Eichele P, Dreyhaupt J, Michels S, Schuster J, Ludolph AC, Senel M, Tumani H. Safety and efficacy of immunoadsorption versus plasma exchange in steroid-refractory relapse of multiple sclerosis and clinically isolated syndrome: A randomised, parallel-group, controlled trial. EClinicalMedicine. 2019 Nov 14;16:98-106. doi: 10.1016/j.eclinm.2019.10.017. eCollection 2019 Nov. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013514 | Surgical Procedures, Operative |