| Italy | Spain–Andalusia | Copenhagen | London | Stockholm | Toulouse | Spain–Catalonia | Salzburg | Tehran |
---|---|---|---|---|---|---|---|---|---|
RRMS with: | |||||||||
≥ 1 clinically documented relapse in past 12 months | x | x | See below | See below | x | x | x | x |  |
≥ 2 clinically documented relapses in last 24 months | x | x | x | x | x | x | x | ||
≥ 1 GEL at MRI performed within the last 12 months or new T2 lesion at MRI performed within the last 12 months compared to a previous MRI performed within the last 12 months. | x | x | x | x | x | x | x | ||
 |  | London: ≥ 1 moderate-severe relapse AND (1 or more GELs in past 18 months OR ≥ 1 new T2 lesion). PLUS: ≥ 1 on MRI within 3 months prior to harvesting | |||||||
 |  | Copenhagen ≥ 1 moderate-severe relapse in past 18 months OR ≥ 1 GEL (double-triple Gad) OR ≥ 1 new T2 | |||||||
SPMS with: | |||||||||
An increase of ≥ 1 EDSS point (if at randomization EDSS ≤ 5.0) or 0.5 EDSS point (if at randomization EDSS ≥ 5.5) in the last 12 months AND ≥ 1 clinically documented relapse or ≥ 1 GEL at MRI within the last 12 months | x | x | No SPMS | See below | x | x | x | x | x |
Other (specify) | Â | London: Changes in EDSS relate to previous 18 months AND 1(+) GELs in last 18 months or require SPMS with 1(+) relapses and 1(+) T2 lesions in past 18 months | |||||||
PPMS with: | |||||||||
An increase of ≥ 1 EDSS point (if at randomization EDSS ≤ 5.0) or 0.5 EDSS point (if at randomization EDSS ≥ 5.5), in the last 12 months | x | x | No PPMS | See below | x | x | x | x | x |
AND ≥ 1 GEL at MRI performed within the last 12 months | x | x | x | x | x | x | x | ||
AND Positive cerebrospinal fluid (CSF) (oligoclonal banding) | x | x | x | x | x | x | x | ||
 |  | London: EDSS changes, GELs, or T2 lesions over last 18 months. PLUS: ≥ 1 on MRI within 3 months prior to harvesting |