Table 5.

Clinical end points according to study group for the all-time on-study population

Characteristics*	Group A (n=10)	Group B (PLP10) (n=10)	Group C (n=9)	Placebo (n=12)	p Value of Group B versus placebo
Annual relapse rate over 1 year†	0.80	0.40	0.78	0.83
Total number of relapses†	8	4	7	10
Primary end points
Annual relapse rate over 2 years (95% CI)†	0.85	0.40 (0.15–0.87)	0.72	1.04	0.024
Total number of relapses†	17	8	13	25
Excluding patients on natalizumab	(n=9)	(n=10)	(n=9)	(n=10)
Annual relapse rate over 2 years (95% CI)	0.83	0.40 (0.10–0.79)	0.72	0.95	0.016
Total number of relapses	15	8	13	19
Secondary end points
Cumulative probability of sustained progression increase by 1 point on EDSS, confirmed after 6 months, over 2 years %†	43	10 (1/10)	24	58 (7/12)	0.019
Excluding patients on natalizumab
Cumulative probability of sustained progression increase by 1 point on EDSS, confirmed after 6 months, over 2 years %	33	10 (1/10)	24	70 (7/10)	0.006
Exploratory results
Patient proportion with ≤1 relapse over 2 years %†	50 (5/10)	90 (9/10)	56 (5/9)	42 (5/12)	0.030
MRI
Patient proportion with new or enlarging T2 lesions %†	–	29 (2/7)	–	67 (4/6)
Excluding patients on natalizumab
Patient proportion with no new or enlarging T2 lesions %	–	29 (2/7)	–	80 (4/5)
DMT (interferons, glatiramer acetate) and natalizumab
Patient proportion on DMT and natalizumab at the end of 2 years %†	80 (8/10)‡	60 (6/10)	67 (6/9)	75 (9/12)§	0.747

*CI denotes confidence interval.

†Including patients on natalizumab.

‡1 of 10 on natalizumab.

§2 of 12 on natalizumab.

DMT, disease-modifying treatment.