Clinical Study

AC-CUTE: An Open-Label Study to Evaluate Progression of Structural Joint Damage and Inflammation in Subjects with Moderate to Severe Rheumatoid Arthritis

Table 2

Changes in TSS and components and RAMRIS feature scores from baseline to Week 24.

FASSC-TCZMSC-TCZC

TSS (X-ray)
Mean (SD)0.46 (1.29)0.65 (1.30)0.36 (1.30)
0.830.930.77
Erosion (X-ray)
Mean (SD)0.14 (0.46)0.16 (0.40)0.12 (0.49)
0.920.990.89
JSN (X-ray)
Mean (SD)0.32 (0.94)0.49 (1.0)0.24 (0.91)
0.890.970.83
Erosion (MRI)
Mean (SD)0.9 (1.66)0.79 (2.0)0.96 (1.5)
0.510.690.55
Cartilage loss (MRI)
Mean (SD)0.12 (0.59)0.09 (0.90)0.14 (0.35)
0.930.970.93
Synovitis (MRI)
Mean (SD)−1.7 (2.67)−1.6 (2.5)−1.8 (2.8)
0.040.370.04
Osteitis (MRI)
Mean (SD)−4.0 (9.58)−2.9 (7.9)−4.6 (10.4)
0.210.550.26

rank-sum test of the hypothesis of no change from baseline at Week 24. Testing change in each subgroup separately; FAS, full analysis set; TSS, Genant-modified total Sharp Score; SC-TCZC, subcutaneous tocilizumab combination therapy subgroup (including MTX); SC-TCZM, subcutaneous tocilizumab monotherapy subgroup (including DMARD(s) but excluding MTX).