| Assessment | Group 1 | Group 2 | Golimumab + methotrexate | ||
| Group 3 | Group 4 | Groups 3 and 4 combined | |||
| Placebo + methotrexate | Golimumab 100 mg + placebo | 50 mg | 100 mg | ||
| Patients randomly assigned | 133 | 133 | 89 | 89 | 178 |
| Primary endpoints | |||||
| ACR20 at week 14 | 44 (33.1%) | 59 (44.4%) | 49 (55.1%) | 50 (56.2%) | 99 (55.6%) |
| p Value | 0.059 | 0.001 | <0.001 | <0.001 | |
| Improvement from baseline in HAQ-DI at week 24 | −0.13 (−0.38 to 0.13) | −0.13 (−0.63 to 0.25) | −0.38 (−0.75 to −0.13) | −0.50 (−0.75 to −0.13) | −0.44 (−0.75 to −0.13) |
| p Value | 0.240 | <0.001 | <0.001 | <0.001 | |
| Secondary endpoints | |||||
| Week 14 | |||||
| ACR50 | 13 (9.8%) | 27 (20.3%) | 31 (34.8%) | 26 (29.2%) | 57 (32.0%) |
| p Value | 0.016 | <0.001 | <0.001 | <0.001 | |
| ACR70 | 5 (3.8%) | 10 (7.5%) | 12 (13.5%) | 8 (9.0%) | 20 (11.2%) |
| p Value | 0.184 | 0.008 | 0.104 | 0.016 | |
| ACR90 | 1 (0.8%) | 1 (0.8%) | 2 (2.2%) | 0 (0.0%) | 2 (1.1%) |
| p Value | 1.000 | 0.344 | 0.412 | 0.740 | |
| ACR-N | 0.00 (−28.60 to 25.50) | 10.50 (−11.80 to 42.60) | 28.20 (0.00 to 60.00) | 25.00 (0.00 to 54.50) | 27.30 (0.00 to 56.30) |
| p Value | 0.042 | <0.001 | <0.001 | <0.001 | |
| Improvement from baseline in HAQ-DI | −0.13 (−0.38 to 0.13) | −0.25 (−0.63 to 0.13) | −0.38 (−0.75 to −0.13) | −0.38 (−0.63 to −0.13) | −0.38 (−0.75 to −0.13) |
| p Value | 0.097 | <0.001 | <0.001 | <0.001 | |
| EULAR responders (DAS28 calculated using ESR) | 59 (44.4%) | 79 (59.4%) | 63 (70.8%) | 67 (75.3%) | 130 (73.0%) |
| p Value | 0.014 | <0.001 | <0.001 | <0.001 | |
| DAS28 (ESR) remission | 2 (1.5%) | 11 (8.3%) | 14 (15.7%) | 16 (18.0%) | 30 (16.9%) |
| p Value | 0.010 | <0.001 | <0.001 | <0.001 | |
| Week 24 | |||||
| ACR20 | 37 (27.8%) | 47 (35.3%) | 53 (59.6%) | 53 (59.6%) | 106 (59.6%) |
| p Value | 0.187 | <0.001 | <0.001 | <0.001 | |
| ACR50 | 18 (13.5%) | 26 (19.5%) | 33 (37.1%) | 29 (32.6%) | 62 (34.8%) |
| p Value | 0.187 | <0.001 | <0.001 | <0.001 | |
| ACR70 | 7 (5.3%) | 15 (11.3%) | 18 (20.2%) | 13 (14.6%) | 31 (17.4%) |
| p Value | 0.075 | <0.001 | 0.017 | 0.001 | |
| ACR90 | 1 (0.8%) | 3 (2.3%) | 5 (5.6%) | 2 (2.2%) | 7 (3.9%) |
| p Value | 0.314 | 0.028 | 0.344 | 0.080 | |
| ACR-N | 0.00 (−25.00 to 22.20) | 0.00 (−25.40 to 37.10) | 36.60 (0.00 to 60.40) | 28.60 (0.00 to 55.30) | 35.70 (0.00 to 60.00) |
| p Value | 0.151 | <0.001 | <0.001 | <0.001 | |
| EULAR responders (DAS28 calculated using ESR) | 56 (42.1%) | 69 (51.9%) | 64 (71.9%) | 68 (76.4%) | 132 (74.2%) |
| p Value | 0.110 | <0.001 | <0.001 | <0.001 | |
| DAS28 (ESR) remission | 8 (6.0%) | 16 (12.0%) | 18 (20.2%) | 20 (22.5%) | 38 (21.3%) |
| p Value | 0.087 | 0.001 | <0.001 | <0.001 | |
| DAS28 (ESR) sustained remission* | 1 (0.8%) | 8 (6.3%) | 9 (10.2%) | 10 (11.9%) | 19 (11.0%) |
| p Value | 0.018 | 0.001 | <0.001 | <0.001 | |
Values are n (%) of patients achieving an endpoint or median (interquartile range) improvement from baseline. *Patients who achieved disease activity score in 28 joints (DAS28) remission at week 14 and maintained it at week 24 were considered to have achieved sustained remission. ACR, American College of Rheumatology response criteria; ESR, erythrocyte sedimentation rate; EULAR, European League Against Rheumatism; HAQ-DI, health assessment questionnaire disability index.