Table 1 Clinical trials
From: The heritage of glatiramer acetate and its use in multiple sclerosis
Study | Number of patients | Trial length | Key outcomes |
|---|---|---|---|
Placebo-controlled trials | |||
Johnson et al. 1995 [53] | 251 randomised 1:1 GA:PBO | 2 years | Mean relapse rate: GA 1.19 versus PBO 1.68; p = 0.007 (29 % reduction) (ARR: GA 0.59 versus PBO 0.84) |
Comi et al. 2001 [54] | 239 randomised 1:1 GA:PBO | 9 months | Mean reduction in total enhancing lesions GA vs PBO -10.8 (95 % CI -18.0 to -3.7; p = 0.003); 29 % reduction. |
Bornstein et al. 1987 [55] | 50 randomised 1:1 GA:PBO | 2 years | Proportion of relapse-free patients GA 56 % vs 26 % PBO; p = 0.045 |
Active comparator-controlled trials | |||
Mikol et al. 2008 [57] (REGARD) | 764 randomised 1:1 GA:IFNβ-1a | 96 weeks | No between-group difference in time to first relapse (HR 0.94; 95 % CI 0.74–1.21; p = 0.64) |
Cadavid et al. 2009 [58] (BECOME) | 75 randomised 1:1 GA: INF-β1b | 2 years | Similar median (75th percentile) CAL count per scan in months 1–12, of 0.58 (2.45) vs 0.63 (2.76) |
O’Connor et al. 2009 [59] (BEYOND) | 2447 randomised 2:2:1 250 μg IFNβ-1b:500 μg IFNβ-1b:GA | 3.5 years | No between-group differences in relapse risk or EDSS progression |
Fox et al. 2012 [60] (CONFIRM) | Randomised 1:1:1:1 PBO: BG-12 twice daily:BG-12 three times daily:GA | 96 weeks | ARR significantly lower with twice-daily BG-12 (0.22), three times-daily BG-12 (0.20), and GA (0.29) than PBO (0.40) (RR GA 29 %, P = 0.01). |
Combination trials | |||
Goodman et al. 2009 [85] (GLANCE) | 110 randomised 1:1 GA + NTZ versus GA alone | 6 months | Mean rate of development of new active lesions over the 24-week study lower with combination therapy (0.03) vs GA alone (0.11; p = 0.031) |
Lindsey et al. 2012 [116] (CombiRx) | 1008 randomised 2:1:1 IFN + GA: IFN: GA | 3 years | No difference in ARR between combination group and GA group (0.12 vs. 0.11). Both combination and GA alone superior to IFN group (0.16; p = 0.022 for combination group and p = 0.027 for GA group) |
Clinically isolated syndrome | |||
Comi et al. 2009 [86] (PreCISe) | 481 randomised 1:1 GA:PBO | 36 months | GA reduced risk of CDMS by 45 % versus PBO (HR 0.55, 95 % CI 0.40–0.77; p = 0.0005) |