Study Phase | Screening | Wash-out | ← Treatment → | Follow up | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Visit* | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10** | 11 | 12 |
Study Week | −4 – 0 | 0 | 4 | 8 | 12 | 16 | 20 | 24 | 28 | 32 | 36 | 40 |
Obtain informed consent | X | |||||||||||
Background/Demography | X | |||||||||||
Inclusion/exclusion criteria | X | X | ||||||||||
Medical History | X | |||||||||||
MS history/MS treatment | X | |||||||||||
Prior/Concomitant medication | X | X | X | X | X | X | X | X | X | X | X | X |
Pregnancy test (serum) | X | |||||||||||
Pregnancy test (urine dipstick) | X | X | X | X | X | X | X | X | X | X | X | |
Physical examination | X | X | X | X | X | X | X | X | X | X | ||
MSFC | X6 | X | X | |||||||||
Neurological examination (including EDSS) | X | X | X | X | X | X | X | X | X | X | ||
Vital signs | X | X | X | X | X | X | X | X | X | X | X | X |
Clinical laboratory (blood chemistry/hematology) | X | X | X | X | X | X | X | X | X | X | X | X |
PBMC isolation for evaluation of immunological parameters | X | X | X | X | X | X | X | X | X | X | X | |
CSF sampling1 | X | X | ||||||||||
JCV sample | X | X | ||||||||||
Ophtalmologic examination2 | X | X | ||||||||||
Last natalizumab dose | X | |||||||||||
ECG | X | |||||||||||
First dose monitoring (=FDM)3 | X | |||||||||||
Dispensing of patient’s diary | X | |||||||||||
Collecting of patient’s diary | X | |||||||||||
Study drug prescription | X | X | X | |||||||||
MRI (including DTI)4,5 | X | X | X | X | X | X | ||||||
MS relapse | X | X | X | X | X | X | X | X | X | X | X | X |
Adverse events/SAEs | X | X | X | X | X | X | X | X | X | X | X |