Table 1

Demographic details of the patients
Part A Part B Part C Pooled
0.03 mg/kg 0.06 mg/kg 0.3 mg/kg 3 mg/kg 10 mg/kg 20 mg/kg 30 mg/kg 6 mg/kg 500 mg Placebo
Number of patients randomized 3 1 8 12 12 6 6 37 12 38a
Age in Years, Mean (SD) 45.7 (9.3) 46.0 50.3 (3.3) 51.1 (8.0) 52.8 (13.4) 58.8 (8.3) 53.2 (5.0) 53.7 (10.1) 55.6 (13.2) 56.2 (11.4)
Gender, n (%)
Female: (%) 3 (100) 1 (100) 5 (63) 9 (75) 5 (42) 4 (67) 4 (7) 23 (62) 10 (83) 35 (92)
Male: (%) 3 (37) 3 (25) 7 (58) 2 (33) 2 (33) 14 (38) 2 (17) 3 (8)
BMI in kg/mb, Mean (SD) 28.0 (3.6) 25.7 27.1 (3.9) 24.8(3.1) 25.2(2.8) 28.3 (3.9) 25.3 (5.8) 26.4 (3.5) 27.9(5.1) 27.5 (4.4)
Disease Duration in years, Mean (SD) 8.4 (10.2) 2.5 6.7 (7.0) 6.0 (6.6) 3.92 (3.4) 14.7 (10.4) 13.4 (13.3) 8.0 (6.9) 8.92 (7.8) 8.0 (7.7)
Number of Prior DMARDs, Mean (SD) 3 (0) 2 2.4 (0.5) 2.7 (0.8) 2.5 (0.7) 3.3 (1.5) 2.7 (1.2) 2.4 (0.7) 2.2 (0.6) 2.4 (0.7)
Rheumatoid Factor Positive N (%) 2 (66) 1 (100) 8 (100) 10 (83) 7 (58) 6 (100) 6 (100) 31 (84) 12 (100) 31 (82)
Anti-CCP antibodies positive N (%) 22(67) 1 (100) 8 (100) 9 (75) 10 (83) 6 (100) 6 (100) NA NA 12 (75)
Baseline DAS28ESR, Median 5.87 6.77 6.47 6.66 6.15 6.91 6.59 6.43 6.40 6.19

aOne patient in the placebo group was randomized and dosed but excluded from the analysis of efficacy because of ineligible DAS28 score (<4.2) pre-dose on day 1; bData missing from 1 patient. BMI, body mass index: DAS28, Disease Activity Score 28; DMARDs, disease modifying anti-rheumatic drugs, SD, standard deviation.

Choy et al.

Choy et al. Arthritis Research & Therapy 2013 15:R132   doi:10.1186/ar4312

Open Data