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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)
  1. 95 % CI 95 % confidence interval, ARR Annualised relapse rate, CAL Combined active lesions, CDMS Clinically definite multiple sclerosis, EDSS Expanded disability status scale, GA Glatiramer acetate, HR Hazard ratio, IFN Interferon, NTZ natalizumab, PBO Placebo, RR Relative risk