Participation in another clinical trial at present or within 4 weeks of study entry. There may be exceptions at the discretion of the Investigator.
Has any progressive form of MS
Hypersensitivity to the active substance, or to any of the excipients of Lemtrada®
Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
Any disability acquired from trauma or another illness that could interfere with evaluation of disability due to MS
Major systemic disease or other illness that would, in the opinion of the Investigator, compromise patient safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease or other conditions that may predispose to hemorrhage
Known bleeding disorder (e.g,. dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation (DIC), fibrinogen deficiency, or clotting factor deficiency)
Significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
History of malignancy, except basal skin cell carcinoma
Major psychiatric disorder that is not adequately controlled by treatment
Epileptic seizures that are not adequately controlled by Treatment
Active infection, e.g., deep-tissue infection, that the Investigator considers sufficiently serious to preclude study participation
In the Investigator's opinion, is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection)
Seropositivity for human immunodeficiency virus (HIV)
Infection with hepatitis C Virus
Past or present hepatitis B infection (positive hepatitis B serology)
Active infection with human cytomegaly virus (HCMV), Epstein-Barr virus (EBV), varicella-zoster virus (VZV)
Latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.
Invasive fungal infections in history and at present
Cervical cytology other than PAP I or PAP II (Papanicolaou) or cervical high risk human papillomavirus (HPV) positivity
Any other illness or infection (latent or active) that, in the Investigator's opinion, could be exacerbated by study medication
Differential blood count < lower limit of normal (LLN) at Screening
Confirmed platelet count < the LLN of the evaluating laboratory at Screening or documented at <100,000/µL within the past year on a sample without platelet clumping
Presence (i.e., above the ULN) of anti-thyroid stimulating hormone receptor antibodies (anti-TSHR) and anti-thyroid peroxidase antibody (anti-TPO)
Vaccination less than 6 weeks prior to treatment with Lemtrada.
Treatment with antineoplastic or immunosuppressive drugs within 8 weeks prior to study inclusion
Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
Inability to undergo MRI with gadolinium administration
Of childbearing potential with a positive serum pregnancy test, pregnant or lactating
Female patients of childbearing potential: Unwilling to agree to use a reliable and acceptable contraceptive method (Pearl index <1) throughout the study period. These methods include: hormone releasing intrauterine device (IUD), hormonal-based contraception, surgical sterilization, abstinence, or double-barrier contraception (condom and occlusive cap [diaphragm or cervical cap combined with spermicide]).

NCT02419378_exc_T2
Condition
MS
NCT02419378_exc_T3
Qualifier
progressive
NCT02419378_exc_T4
Condition
Hypersensitivity
NCT02419378_exc_T5
Drug
Lemtrada
NCT02419378_exc_T9
Condition
bleeding disorder
NCT02419378_exc_T10
Condition
dysfibrinogenemia
NCT02419378_exc_T11
Condition
factor IX deficiency
NCT02419378_exc_T12
Condition
hemophilia
NCT02419378_exc_T13
Condition
Von Willebrand's disease
NCT02419378_exc_T14
Condition
disseminated intravascular coagulation
NCT02419378_exc_T15
Condition
DIC
NCT02419378_exc_T16
Condition
fibrinogen deficiency
NCT02419378_exc_T17
Condition
clotting factor deficiency
NCT02419378_exc_T18
Scope
dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation (DIC), fibrinogen deficiency, or clotting factor deficiency
NCT02419378_exc_T19
Condition
autoimmune disease
NCT02419378_exc_T20
Condition
immune cytopenias,
NCT02419378_exc_T21
Condition
rheumatoid arthritis,
NCT02419378_exc_T22
Condition
systemic lupus erythematosus
NCT02419378_exc_T23
Condition
connective tissue disorders
NCT02419378_exc_T24
Condition
vasculitis
NCT02419378_exc_T25
Condition
inflammatory bowel disease
NCT02419378_exc_T26
Condition
psoriasis
NCT02419378_exc_T27
Qualifier
severe
NCT02419378_exc_T28
Scope
immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
NCT02419378_exc_T29
Condition
malignancy
NCT02419378_exc_T30
Negation
except
NCT02419378_exc_T31
Condition
basal skin cell carcinoma
NCT02419378_exc_T32
Condition
psychiatric disorder
NCT02419378_exc_T33
Qualifier
Major
NCT02419378_exc_T34
Qualifier
adequately controlled
NCT02419378_exc_T35
Negation
not
NCT02419378_exc_T36
Condition
Epileptic seizures
NCT02419378_exc_T37
Qualifier
adequately controlled
NCT02419378_exc_T38
Negation
not
NCT02419378_exc_T39
Condition
infection
NCT02419378_exc_T40
Qualifier
Active
NCT02419378_exc_T41
Condition
deep-tissue infection
NCT02419378_exc_T42
Observation
risk for infection
NCT02419378_exc_T43
Qualifier
high
NCT02419378_exc_T44
Device
indwelling catheter
NCT02419378_exc_T45
Condition
dysphagia
NCT02419378_exc_T46
Condition
aspiration
NCT02419378_exc_T47
Condition
decubitus ulcer
NCT02419378_exc_T48
Condition
aspiration pneumonia
NCT02419378_exc_T49
Condition
urinary tract infection
NCT02419378_exc_T50
Qualifier
recurrent
NCT02419378_exc_T51
Scope
indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection
NCT02419378_exc_T52
Measurement
human immunodeficiency virus
NCT02419378_exc_T53
Measurement
HIV
NCT02419378_exc_T54
Value
Seropositivity
NCT02419378_exc_T55
Qualifier
hepatitis C Virus
NCT02419378_exc_T56
Condition
Infection
NCT02419378_exc_T57
Condition
hepatitis B infection
NCT02419378_exc_T58
Measurement
hepatitis B serology
NCT02419378_exc_T59
Value
positive
NCT02419378_exc_T60
Qualifier
human cytomegaly virus
NCT02419378_exc_T61
Qualifier
HCMV
NCT02419378_exc_T62
Qualifier
Epstein-Barr virus
NCT02419378_exc_T63
Qualifier
EBV
NCT02419378_exc_T64
Qualifier
varicella-zoster virus
NCT02419378_exc_T65
Qualifier
VZV
NCT02419378_exc_T66
Condition
infection
NCT02419378_exc_T67
Qualifier
Active
NCT02419378_exc_T68
Scope
human cytomegaly virus (HCMV), Epstein-Barr virus (EBV), varicella-zoster virus (VZV)
NCT02419378_exc_T69
Condition
Latent tuberculosis
NCT02419378_exc_T70
Negation
unless
NCT02419378_exc_T71
Procedure
anti-tuberculosis therapy
NCT02419378_exc_T72
Qualifier
completed
NCT02419378_exc_T73
Condition
active tuberculosis
NCT02419378_exc_T74
Condition
fungal infections
NCT02419378_exc_T75
Qualifier
Invasive
NCT02419378_exc_T76
Measurement
Cervical cytology
NCT02419378_exc_T77
Negation
other
NCT02419378_exc_T78
Qualifier
PAP I
NCT02419378_exc_T79
Qualifier
PAP II
NCT02419378_exc_T80
Qualifier
Papanicolaou
NCT02419378_exc_T82
Qualifier
human papillomavirus
NCT02419378_exc_T83
Qualifier
cervical high risk
NCT02419378_exc_T84
Qualifier
HPV
NCT02419378_exc_T85
Value
positivity
NCT02419378_exc_T86
Value
Participation
NCT02419378_exc_T87
Scope
other than PAP I or PAP II (Papanicolaou) or cervical high risk human papillomavirus (HPV)
NCT02419378_exc_T88
Scope
PAP I or PAP II (Papanicolaou)
NCT02419378_exc_T89
Scope
cervical high risk human papillomavirus (HPV)
NCT02419378_exc_T81
Condition
illness
NCT02419378_exc_T90
Condition
infection
NCT02419378_exc_T91
Qualifier
latent
NCT02419378_exc_T92
Qualifier
active
NCT02419378_exc_T93
Temporal
active
NCT02419378_exc_T95
Qualifier
exacerbated by study medication
NCT02419378_exc_T96
Drug
study medication
NCT02419378_exc_T97
Scope
latent or active
NCT02419378_exc_T98
Scope
illness or infection
NCT02419378_exc_T99
Measurement
Differential blood count
NCT02419378_exc_T100
Value
< lower limit of normal (LLN)
NCT02419378_exc_T101
Temporal
at Screening
NCT02419378_exc_T102
Measurement
platelet count
NCT02419378_exc_T103
Qualifier
Confirmed
NCT02419378_exc_T104
Value
< the LLN of the evaluating laboratory
NCT02419378_exc_T105
Temporal
at Screening
NCT02419378_exc_T106
Value
<100,000/µL
NCT02419378_exc_T107
Temporal
within the past year
NCT02419378_exc_T108
Qualifier
sample without platelet clumping
NCT02419378_exc_T109
Scope
< the LLN of the evaluating laboratory at Screening or documented at <100,000/µL within the past year
NCT02419378_exc_T110
Value
above the ULN
NCT02419378_exc_T111
Value
Presence
NCT02419378_exc_T112
Measurement
anti-thyroid stimulating hormone receptor antibodies (anti-TSHR)
NCT02419378_exc_T113
Measurement
anti-thyroid peroxidase antibody (anti-TPO)
NCT02419378_exc_T114
Scope
anti-thyroid stimulating hormone receptor antibodies (anti-TSHR) and anti-thyroid peroxidase antibody (anti-TPO)
NCT02419378_exc_T115
Drug
Vaccination
NCT02419378_exc_T116
Temporal
less than 6 weeks prior to treatment with Lemtrada
NCT02419378_exc_T117
Reference_point
treatment with Lemtrada
NCT02419378_exc_T118
Procedure
treatment
NCT02419378_exc_T119
Drug
Lemtrada
NCT02419378_exc_T120
Procedure
Treatment
NCT02419378_exc_T121
Drug
uppressive dru r to
NCT02419378_exc_T122
Drug
immunosuppressive drugs
NCT02419378_exc_T123
Temporal
within 8 weeks prior to study inclusion
NCT02419378_exc_T124
Reference_point
study inclusion
NCT02419378_exc_T125
Scope
antineoplastic or immunosuppressive drugs
NCT02419378_exc_T126
Drug
pulsed corticosteroids
NCT02419378_exc_T127
Observation
history of
NCT02419378_exc_T128
Condition
steroid psychosis
NCT02419378_exc_T129
Condition
Intolerance
NCT02419378_exc_T130
Condition
Inability to undergo MRI
NCT02419378_exc_T131
Procedure
MRI
NCT02419378_exc_T132
Drug
gadolinium
NCT02419378_exc_T133
Mood
Inability to
NCT02419378_exc_T134
Person
childbearing potential
NCT02419378_exc_T135
Value
positive
NCT02419378_exc_T136
Measurement
serum pregnancy test
NCT02419378_exc_T137
Condition
pregnant
NCT02419378_exc_T138
Condition
lactating
NCT02419378_exc_T139
Person
Female
NCT02419378_exc_T140
Person
childbearing potential
NCT02419378_exc_T141
Scope
Female patients of childbearing potential