Table 1

Baseline characteristics of the IIT and the PP patient cohort

Intention-to-treat cohort (n=38)Per-protocol cohort (n=28)
Age (years)37.2±10.038.0±10.5
Women29 (76%)23 (82%)
Disease course: CIS, RRMS1/371/27
Time since onset (years)7.9±8.58.6±9.3
Time since diagnosis (years)5.8±6.26.2±6.7
EDSS at baseline1.76±1.081.57±0.98
MSFC at baseline0.49±0.540.00±0.58
Number of relapses in the last 12 months1.0±0.70.9±0.5
Number of relapses in the last 24 months1.6±0.91.5±0.8
Number of patients with previous MS treatments*13 (36%)10 (36%)
Total number of contrast-enhancing lesions during baseline phase1.25 (0.75–3.50)1.00 (0.75–3.38)
Number of new contrast-enhancing lesions during baseline phase1.00 (0.75–3.00)0.88 (0.63–2.63)
Total number of T2 lesions during baseline phase33.88 (23.33–62.00)30.21 (22.00–49.13)
Number of new T2 lesions during baseline phase8.50 (4.75–14.50)7.50 (4.88–12.88)
  • Data are presented as mean (SD) or absolute numbers, MRI parameters are presented as median (IQR).

  • *Patients may have received more than one previous multiple sclerosis disease-modifying drug. There were no significant differences between the intention-to-treat and the per-protocol patient cohort.

  • CIS, clinically isolated syndrome; EDSS, Expanded Disability Status Scale; ITT, intention to treat; MS, multiple sclerosis; MSFC, multiple sclerosis functional composite; PP, per protocol; RRMS, relapsing-remitting multiple sclerosis.