Table 1. Summary of 4 Phase III Studies of Ocrelizumab.
| Trial Name | Patients Treated, n | RA Characteristics | Treatment Groups+MTXa | Duration of PBO-Controlled Period, weeks |
| STAGE | 1006 | MTX-IR; 51% to 54% steroid use; Baseline DAS28 ≈6.4 | PBO (n = 320); OCR200 (n = 343); OCR500 (n = 343) | 48 |
| SCRIPT | 836 | TNF-IR; 56% to 62% steroid use; Baseline DAS28 ≈6.5 | PBO (n = 277); OCR200 (n = 277); OCR500 (n = 282) | 48 |
| FEATURE | 312 | MTX-IR/biological DMARD-IR; 52% to 59% steroid use; Baseline DAS28 ≈6.5 | PBO (n = 64); OCR200 (n = 131); OCR400 (n = 117) | 24 |
| FILM | 605 | MTX-naïve; 39% to 42% steroid use; Baseline DAS28 ≈7.0 | PBO (n = 207); OCR200 (n = 196); OCR500 (n = 202) | 104b |
Abbreviations: DAS28, disease activity score in 28 joints; DMARD, disease-modifying antirheumatic drug; IR, inadequate responder; MTX, methotrexate; OCR200, ocrelizumab 200 mg×2; OCR500, ocrelizumab 500 mg×2; PBO, placebo; RA, rheumatoid arthritis; TNF, tumor necrosis factor.
a
All patients in all studies received background MTX 7.5 to 25 mg/week (7.5–20 mg/week in FILM), except for in SCRIPT, in which MTX or leflunomide was permitted. Treatment with corticosteroids (≤10 mg/day prednisolone or equivalent) was permitted in all studies provided the dose was stable 4 weeks prior to baseline.
b
Study terminated early. Safety evaluation conducted for 52-week data.