Table 1.
Study assessment timeline
| Pre-allocation | Allocation |
Post-allocation Follow-up visits |
Post-allocation Close-out |
||||||
|---|---|---|---|---|---|---|---|---|---|
| Visit | - | V1 | V2 | V3 | V6 | V7 | V8 | V9 | V10 |
| Time | M0 (− 14d) | M0 | M6 (± 45d) | M12 (± 45d) | M18 (± 45d) | M 24 (± 45d) | M30 (± 45d) | M36 (± 45d) | M42 (± 45d) |
| Recruitment | |||||||||
| Eligibility screening | X | ||||||||
| Informed consent | X | ||||||||
| Randomization | X | ||||||||
| Baseline characteristicsa | X | X | |||||||
| Intervention | X | X | X | X | X | X | X | X | |
| Primary outcomes | |||||||||
| MSQoL-54a | X | X | |||||||
| EDA3a | X | X | |||||||
| Secondary outcomes | |||||||||
| MSQoL-54a | X | X | X | ||||||
| EDA3a | X | X | X | ||||||
| Relapsesa | X | X | X | ||||||
| EDSSa | X | X | X | ||||||
| Lesionsa | X | X | X | ||||||
| Amount of DMTab | X | X | |||||||
| SAE | X | X | X | X | X | X | X | X | |
|
Indicators of harma - Relapses - EDSS - Opportunistic infections |
X x x x |
(X) (x) (x) (x) |
X x x x |
(X) (x) (x) (x |
X x x x |
(X) (x) (x) (x |
X x x x |
(X) (x) (x) (x |
|
| Other outcomes | |||||||||
| EQ-5D-5La | X | X | X | ||||||
|
Other PROs: - Professional activitya - Healthcare utilization—Hospitalizationa |
X X |
X X |
X X |
||||||
aRoutinely collected data within the SMSC; (X) only when it coincides with a SMSC visi
bDefined as the daily dose following WHO recommendations