Screening | Random (month 0) | Tel.V1 -6 (week 0, 2, 4, 6, 8, 10, 16, 20, 28, 32, 40, 44) ± 3 days | V1 (month 3) ± 10 days | V2 (month 6) ± 10 days | V3 (month 9) ± 10 days | V4 (month 12) ± 10 days | V5 (month 15) ± 10 days (optional) | V6 (month 18) ± 10 days (optional) | |
---|---|---|---|---|---|---|---|---|---|
Informed consent | x | ||||||||
In/exclusion criteria | x | x | |||||||
Randomization | x | ||||||||
Demographic data | x | ||||||||
Pregnancy test | x | ||||||||
Confirmation of MS diagnosis | x | ||||||||
Relapse history | x | x | x | x | x | x | x | x | |
Medical history | x | x | x | x | x | x | x | x | |
Physical examination | x | x | x | x | x | x | |||
Vital signs | x | x | x | x | x | x | x | ||
Weight | x | x | x | ||||||
MSFC | x | x | x | ||||||
EDSS | x | x | x | x | x | x | x | ||
Safety lab | x | x | x | x | x | x | |||
Immunological sampling | x | x | x | x | x | x | |||
MRI | x | x | x | x | optional | optional | |||
AE/SAE | x | x | x | x | x | x | |||
Questionnaires (fatigue, depression) | x | x | x | x | x | x | x | ||
Drug supply | x | x | x | x | x | ||||
Drug account | x | x |