Table 1

Tocilizumab phase III studies6–10

Patient populationPatients, nTreatment armsClinical endpointStudy duration
MTX-naïve/free*
AMBITION6
673TCZ monotherapy vs MTXSigns and symptoms6 months
+LTE
MTX-IR†
OPTION7
623TCZ + MTX
vs MTX
Signs and symptoms6 months
+LTE
MTX-IR†
LITHE8
1190TCZ + MTX
vs MTX
Prevention of joint damage
Improvement in physical function and disability
2 years +
3 year extension
csDMARD-IR‡
TOWARD9
1220TCZ + DMARD
vs DMARD
Signs and symptoms6 months
+LTE
Anti-TNF-IR§
RADIATE10
499TCZ + MTX
vs MTX
Signs and symptoms6 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.