Table 1

Baseline demographic and disease characteristics

 Part APart B
 PlaceboSirukumabPlaceboSirukumab
 100 mg every 2 weeks100 mg every 2 weeks100 mg every 4 weeks50 mg every 4 weeks25 mg every 4 weeks
Randomised patients, n19173030303031
Male, n (%)8 (42.1)3 (17.6)5 (16.7)3 (10.0)3 (10.0)4 (13.3)8 (25.8)
Race, n (%)
 Caucasian18 (94.7)16 (94.1)19 (63.3)19 (63.3)19 (63.3)16 (53.3)18 (58.1)
 Black1 (5.3)1 (5.9)01 (3.3)1 (3.3)00
 Asian005 (16.7)6 (20.0)6 (20.0)8 (26.7)7 (22.6)
 Other006 (20.0)4 (13.3)4 (13.3)6 (20.0)6 (19.4)
Age (years), mean (SD)46.2 (10.2)50.1 (10.7)54.1 (12.7)53.8 (13.0)52.0 (11.0)50.9 (10.3)52.8 (9.4)
Weight (kg), mean (SD)82.2 (21.7)81.0 (19.6)69.0 (14.0)69.7 (14.9)69.3 (14.4)69.3 (19.2)69.2 (14.4)
Disease duration (years), mean (SD)7.5 (6.9)7.3 (6.7)7.7 (6.8)8.3 (6.3)9.3 (8.1)9.9 (9.4)6.6 (7.0)
Rheumatoid factor/ anti-CCP positive (%/%)100/89100/10097/9097/87100/9390/10090/100
No. of tender joints (0−68), mean (SD)28.1 (12.5)24.9 (14.6)24.2 (11.8)22.3 (13.8)29.1 (16.2)26.4 (15.0)24.5 (11.8)
No. of swollen joints (0−66), mean (SD)15.4 (8.6)15.0 (6.1)15.1 (7.8)14.9 (8.1)16.2 (10.2)14.2 (8.0)12.9 (5.7)
Patient's assessment of pain (VAS 0−10 cm), mean (SD)6.4 (1.8)6.9 (1.7)6.3 (2.0)6.2 (1.9)6.9 (1.9)6.8 (2.1)5.5 (2.3)
Patient's global assessment of disease activity (VAS 0−10 cm), mean (SD)6.4 (2.1)6.9 (1.8)6.8 (2.0)6.0 (2.2)6.8 (2.1)6.8 (2.0)5.4 (2.4)
Physician's global assessment of disease activity (VAS 0−10 cm), mean (SD)6.0 (1.6)5.8 (1.7)6.0 (1.7)6.2 (1.6)6.5 (1.4)6.9 (1.2)6.0 (2.0)
CRP (mg/dL), mean (SD)4.1 (2.6)2.1 (1.1)2.0 (1.8)2.6 (2.8)2.8 (2.4)2.4 (1.9)2.0 (1.5)
HAQ-DI (0−3), mean (SD)1.53 (0.58)1.63 (0.42)1.46 (0.57)1.56 (0.67)1.58 (0.69)1.62 (0.64)1.48 (0.66)
DAS28-CRP, mean (SD)6.3 (0.9)5.9 (1.0)5.9 (0.7)5.8 (1.0)6.2 (0.7)6.1 (0.9)5.7 (0.9)
CDAI, mean (SD)42.5 (14.0)39.0 (14.5)39.0 (11.5)37.6 (12.2)41.8 (11.4)40.7 (11.2)36.8 (12.8)
SDAI, mean (SD)46.4 (14.8)41.2 (14.7)41.0 (12.0)40.1 (12.6)44.6 (11.5)43.1 (12.0)38.9 (12.7)
SF-36 PCS score, mean (SD)30.5 (6.8)29.2 (7.1)31.8 (6.9)31.3 (6.4)30.0 (9.2)31.3 (6.6)33.3 (9.3)
SF-36 MCS score, mean (SD)37.4 (13.6)37.4 (8.9)35.5 (10.4)38.2 (13.6)36.7 (11.7)34.6 (10.5)41.0 (10.5)
MTX therapy duration (years), n (%)
 <15 (26.3)1 (5.9)5 (16.7)8 (26.7)5 (16.7)4 (13.3)9 (29.0)
 1–<36 (31.6)10 (58.8)8 (26.7)7 (23.3)10 (33.3)14 (46.7)9 (29.0)
 ≥38 (42.1)6 (35.3)17 (56.7)15 (50.0)15 (50.0)12 (40.0)13 (41.9)
  • anti-CCP, anti-cyclic citrullinated peptide; CDAI, clinical disease activity index; CRP, C-reactive protein; DAS28-CRP, 28-joint count disease activity score using CRP; HAQ-DI, health assessment questionnaire disability index; PCS/MCS, physical/mental component summary; SDAI, simplified disease activity index; SF-36, 36-item short form health survey; MTX, methotrexate; VAS, visual analogue scale.