Table 2 RRMS sub-cohort inclusion and exclusion criteria
RRMS sub-cohort (n = 200) | |
|---|---|
Inclusion criteria | |
Age 18–60 | |
EDSS [6] ≤ 6.5 | |
RRMS diagnosis or CIS diagnosis with MRI evidence of dissemination in space [8], with symptom onset ≤5 years | |
Treatment naïve or no disease modifying treatment ≥6 months | |
At least 100 participants demonstrating “high” disease activity defined by: • 2 or more relapses in the past year OR • 1 relapse in the past year and > 10 T2 lesions and > 3 Gad+ lesion OR • 1 relapse in the past year and > 10 T2 lesions and > 3 new T2 lesions in the past 1–2 years OR • 1 relapse in the past year and > 10 T2 lesions and brainstem/spinal cord involvement (clinically or on MRI) • 1 relapse in the past year with > 10 T2 lesions with incomplete relapse recovery and EDSS > 2.0 | |
Exclusion criteria | |
HIV positive | |
Previous or current treatment with chemotherapy for malignancy |