Table 1 Study schedule

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

Treatment

25

26

27

28

29

30

31

32

33

34

353

36

1st infusion

37

38

39

40

41

42

43

44

45

46

47

48

baseline

2nd infusion

49

50

51

52

53

54

55

56

57

58

59

60

Singed declaration of informed consent

x

Patient characteristics (age and sex)

x

MS anamnesis

- Diagnosis

x

- Date of first diagnosis (RRMS)

x

- Number of relapses in the last year and the year before

x

- Comorbidities including fatigue and depression

x

- Previous MS basis therapy

x

Relapses during observation time

- Number

x

x

x

x

x

x

x

x

x

x

x

x

x

- Number of relapses treated with cortisone

x

x

x

x

x

x

x

x

x

x

x

x

x

EDSS (Expanded Disability Status Scale)

x

x

x

x

x

SDMT (Symbol Digit Modality Test)

x

x

x

PRIM US (Patient-Reported Indices for MS)

x

x

x

EuroQol (ED-SD)

x

x

x

Responding to treatment/clinical evaluation

CGI (Clinical Global Impressions Scale):

- Details provided by the physician

x

x

x

- Details provided by the patient

x

x

x

Economic parameters

WPAI (Work productivity and Activity Impairment Questionnaire)

x

x

x

Examinations before and after therapy with Lemtrada^®

Pre-existing illnesses

x

Bodily examination

x

Total and differential blood count

x

x

x

x

x

x

x

x

x

x

x

x

x

x

Serum creatine level

x

x

x

x

x

x

x

x

x

x

x

x

x

Urine status

x

x

x

x

x

x

x

x

x

x

x

x

x

Thyroid gland function (TSH)

x

x

x

x

x

x

Vaccination status

x

Infections

x

HIV infection

x

Test for tuberculosis

x

Test for hepatits B and C

x

Tests for varicella-zoster virus

x

Test for JC virus

x

Contraception/exclusion of an existing pregnancy

x

x

Adverse events since therapy start

x

x

x

x

x

x

x

x

x

x

x

x

MRI (new T2 or Gd(+)-lesions)

x