Escalationtherapy of a MS-relapse by Methylprednisolone vs Immunoadsorption

INTERVENTION: Intervention 1: Immunoadsorption (IA): a selective extracorporeal blood purification technique, performed in 5 sessions within 10 days Intervention 2: Daily infusion of 2000 mg i.v. methylprednisolone for 5 days CONDITION: G35 ‐ Multiple sclerosis PRIMARY OUTCOME: To prove the superiority of immunoadsorption over a 2nd course of methylprednisolone as an escalating treatment of steroid refractory relapses in RRMS (relapsing‐remitting multiple sclerosis) and CIS (clinically isolated syndrom). ; ; Primary efficacy endpoint: EDSS (Expanded Disability Status Scale) on day 45 or before start of any rescue treatment after EoT (end of tratment), (if applicable). SECONDARY OUTCOME: Validation of the superiority of immunoadsorption based on further neurological evaluations (e.g. MS functional composite/MSFC) and comparison of the two treatment modalities regarding safety and patient satisfaction (acceptance, well‐being, quality of life).; ; Key secondary endpoints (sEP) ; • subscore in the functional system predominantly affected by the current relapse (pFS) ; • MSFC (MS Functional Composite); • visual acuity (by Snellen score); in optic neuritis; • HRQoL measures (Health‐Related Quality of Life); Secondary Outcomes will be analysed on day 45 and at end of study. INCLUSION CRITERIA: 1. = 18 years 2. Diagnosis of MS (according to McDonald criteria, revision of 2017) 3. Acute relapse (new or recurring symptoms lasting at least 24 hrs, affecting the subject’s activities of daily living [ADL]) 4. Initial therapy of current relapse with IVMP (2500 ‐ 5000 mg total dose) with unsatisfactory response 5. EDSS at screening 2.0‐8.0 (Expanded Disability Status Scale) 6. At screening, interval since onset of current relapse maximum 28 days 7. At screening, interval since end of initial course of IVMP** at least 7 days 8. Before onset of qualifying MS relapse, clinically stable for at least 30 days 9. Written informed consent