Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis and Clinically Isolated Syndrome

Conditions
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Multiple Sclerosis, Clinically Isolated Syndrome

Intervention / Treatment
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* Procedure: Immunoadsorption
* Procedure: Plasmapheresis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: relapse of Multiple Sclerosis or Clinically Isolated Syndrome (without complete remission after high dose steroid therapy) informed consent age ≥ 12 years old Exclusion Criteria: clinical or laboratory signs of infection intake of Angiotensin Converting Enzyme Inhibitor within 1 week prior to first treatment

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunoadsorption<br>Immunoadsorption on 5 consecutive days with protein A columns and 2,5-fold patient's plasma volume | Procedure: Immunoadsorption<br> <br> |
| Active Comparator: Plasmapheresis<br>Plasmapheresis on 5 consecutive days with 2l plasma exchange | Procedure: Plasmapheresis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple Sclerosis Functional Composite (MSFC) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expanded Disability Status Scale (EDSS) |  | 2 and 4 weeks | 
| EuroQol (EQ5D-5L) |  | 2 and 4 weeks | 
| Response Rate | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunoadsorption, Plasmapheresis