Patient population | Patients, n | Treatment arms | Clinical endpoint | Study duration |
MTX-naïve/free* AMBITION6 | 673 | TCZ monotherapy vs MTX | Signs and symptoms | 6 months +LTE |
MTX-IR† OPTION7 | 623 | TCZ + MTX vs MTX | Signs and symptoms | 6 months +LTE |
MTX-IR† LITHE8 | 1190 | TCZ + MTX vs MTX | Prevention of joint damage Improvement in physical function and disability | 2 years + 3 year extension |
csDMARD-IR‡ TOWARD9 | 1220 | TCZ + DMARD vs DMARD | Signs and symptoms | 6 months +LTE |
Anti-TNF-IR§ RADIATE10 | 499 | TCZ + MTX vs MTX | Signs and symptoms | 6 months +LTE |
Total | 4205 |
AMBITION is a comparison of TCZ monotherapy versus MTX monotherapy; in the other studies listed, MTX=placebo (+background MTX)
*MTX-naïve or MTX-free for 6 months before randomisation.
†MTX-IR is patients with an inadequate response to MTX.
‡csDMARD-IR is patients with an inadequate response to ≥1 csDMARD.
§Anti-TNF-IR is patients with an inadequate response to ≥1 TNF inhibitor.
DMARD, disease modifying anti-rheumatic drug; LTE, long term extension; MTX, methotrexate; TCZ, tocilizumab; TNF, tumour necrosis factor.