Signed informed consent form (ICF)
Age 18 to 55 years old (inclusive) as of the date the ICF is signed
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
Onset of MS symptoms (as determined by a neurologist, either at present or retrospectively) within 10 years of the date the ICF is signed
EDSS score 0.0 to 5.0 (inclusive) at Screening
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 diseasemodifying therapies, 3. severe relapse with high disease activity (=9 T2 hyperintense Lesions and =1 gadolinium enhancing lesion) on MRI.
Completion of all vaccinations required by the applicable immunization guidelines published by "ständige Impfkommission" (STIKO)
History of chickenpox or positive test for antibodies against varicella zoster virus (VZV)

NCT02419378_inc_T2
Person
Age
NCT02419378_inc_T3
Value
18 to 55 years old (
NCT02419378_inc_T4
Condition
MS
NCT02419378_inc_T5
Measurement
McDonald criteria 2010
NCT02419378_inc_T6
Procedure
cranial MRI scan
NCT02419378_inc_T7
Temporal
within 10 years before Screening
NCT02419378_inc_T8
Scope
McDonald criteria 2010 and cranial MRI scan
NCT02419378_inc_T9
Condition
MS symptoms
NCT02419378_inc_T10
Temporal
within 10 years
NCT02419378_inc_T11
Measurement
EDSS score
NCT02419378_inc_T12
Value
0.0 to 5.0
NCT02419378_inc_T13
Condition
RRMS
NCT02419378_inc_T14
Qualifier
active
NCT02419378_inc_T15
Drug
alemtuzumab
NCT02419378_inc_T16
Condition
MS relapses
NCT02419378_inc_T17
Multiplier
=2
NCT02419378_inc_T18
Temporal
within 24 months,
NCT02419378_inc_T19
Condition
relapse
NCT02419378_inc_T20
Multiplier
=1
NCT02419378_inc_T21
Procedure
MRI
NCT02419378_inc_T22
Condition
relapse
NCT02419378_inc_T23
Qualifier
severe
NCT02419378_inc_T24
Condition
Lesions
NCT02419378_inc_T25
Qualifier
T2 hyperintense
NCT02419378_inc_T26
Multiplier
=9
NCT02419378_inc_T27
Condition
lesion
NCT02419378_inc_T28
Qualifier
gadolinium enhancing
NCT02419378_inc_T29
Multiplier
=1
NCT02419378_inc_T30
Procedure
MRI
NCT02419378_inc_T31
Condition
lesions
NCT02419378_inc_T32
Qualifier
gadolinium enhancing
NCT02419378_inc_T33
Qualifier
new
NCT02419378_inc_T34
Scope
clinical (=1 relapse) or MRI (new gadolinium enhancing lesions)
NCT02419378_inc_T35
Scope
=9 T2 hyperintense Lesions and =1 gadolinium enhancing lesion
NCT02419378_inc_T37
Condition
chickenpox
NCT02419378_inc_T38
Measurement
test for antibodies
NCT02419378_inc_T39
Value
positive
NCT02419378_inc_T40
Qualifier
varicella zoster virus
NCT02419378_inc_T41
Qualifier
VZV