Patients must meet all of the following criteria to be eligible for further study participation: |
1. Signed informed consent form (ICF) |
2. Age 18 to 55 years old (inclusive) as of the date the ICF is signed |
3. Diagnosis of MS according to the McDonald criteria 2010 and cranial MRI scan demonstrating white matter lesions attributable to MS within 10 years before screening |
4. Onset of MS symptoms (as determined by a neurologist, either at present or retrospectively) within 10 years of the date the ICF is signed |
5. EDSS score 0.0 to 5.0 (inclusive) at Screening |
6. Patients with (highly) active RRMS disease course indicated to receive alemtuzumab according to the following conditions (at least 1 out of 3 conditions has to be fulfilled): |
1. ≥2 MS relapses within 24 months |
2. Clinical (≥1 relapse) or MRI (new gadolinium enhancing lesions) disease activity under therapy with other disease-modifying therapies |
3. Severe relapse with high disease activity (≥9 T2 hyperintense Lesions and ≥1 gadolinium enhancing lesion) on MRI. |
7. Completion of all vaccinations required by the applicable immunization guidelines published by “ständige Impfkommission” (STIKO) |
8. History of chickenpox or positive test for antibodies against varizella zoster virus (VZV) |