Table 1.
Overview of the phase III study program of tocilizumab.
| Patient Population | Number of patients | Treatment arms | Clinical end point | Study duration |
|---|---|---|---|---|
| MTX-naïve/free AMBITION | 673 | TCZ monotherapy vs. MTX | Signs and symptoms | 6 months + LTE |
| MTX IR OPTION | 623 | TCZ + MTX vs. MTX | Signs and symptoms | 6 months + LTE |
| MTX IR LITHE | 1190 | TCZ + MTX vs. MTX | Prevention of joint damage in physical function and disability | 2 years + 3-year extension (ongoing) |
| DMARD IR TOWARD | 1220 | TCZ + DMARD vs. DMARD | Signs and symptoms | 6 months + LTE |
| Anti-TNF IR RADIATE | 499 | TCZ + MTX vs. MTX | Signs and symptoms | 6 months + LTE |
Total number of patients: 4205.
MTX, methotrexate; IR, inadequate responder; TCZ, tocilizumab; TNF, tumor necrosis factor; DMARD, disease-modifying antirheumatic drug; LTE, long-term extension.