Table 2.
Major phase 3 studies in RA: RAPID 1, RAPID 2 and FAST4WARD
| RAPID 1 (NCT00152386)7 Phase 3 trial: Moderate-to-severe RA patients who have had an inadequate response to MTX (n = 982) | ||||
| SC CZP 200 mg (400 mg loading dose at weeks 0, 2 and 4) or 400 mg, or placebo every 2 weeks for 52 weeks. All patients received stable entry dose MTX (≥10 to 25 mg/wk). Study has an open-label extension of 3 years. | ||||
| Endpoints | Placebo + MTX (n = 199) | CZP 200 mg + MTX (n = 393) | CZP 400 mg + MTX (n = 390) | |
| Co-primary | ACR20 wk 24 | 13.6% | 58.8% (p < 0.001) | 60.8% (p < 0.001) |
| mTSS mean change from baseline wk 52 | 2.8 | 0.4 (p < 0.001*) | 0.2 (p < 0.001*) | |
| ACR20 wk 52 | 13.1% | 53.1% (p < 0.001) | 54.9% (p < 0.001) | |
| Selected Secondary | ACR50 wk 52 | 7.6% | 38.0% (p < 0.001) | 39.9% (p < 0.001) |
| ACR70 wk 52 | 3.5% | 21.2% (p < 0.001) | 23.2% (p < 0.001) | |
| mTSS mean change from baseline wk 24 | 1.3 | 0.2 (p < 0.001) | 0.2 (p < 0.001) | |
| HAQ-DI mean change from baseline wk 52 | −0.18 | −0.60 (p < 0.001) | −0.63 (p < 0.001) | |
| RAPID 2 (NCT00160602)8Phase 3 trial: Moderate-to-severe RA patients who have had an inadequate response to MTX (n = 619) | ||||
| SC CZP 200 mg (400 mg loading dose at weeks 0, 2 and 4) or 400 mg, or placebo every 2 weeks for 24 weeks. All patients received stable entry dose MTX (≥10 to 25 mg/wk). Study has an open-label extension of 3 years. | ||||
| Endpoints at week 24 | Placebo + MTX (n = 127) | CZP 200 mg + MTX (n = 246) | CZP 400 mg + MTX (n = 246) | |
| Primary | ACR20 | 8.7% | 57.3% (p < 0.001) | 57.6% (p < 0.001) |
| Selected Secondary | ACR50 | 3.1% | 32.5% (p < 0.001) | 33.1% (p < 0.001) |
| ACR70 | 0.8% | 15.9% (p ≤ 0.01) | 10.6% (p ≤ 0.01) | |
| mTSS mean change from baseline | 1.2 | 0.2 (p ≤ 0.01*) | −0.4 (p ≤ 0.001*) | |
| HAQ-DI mean change from baseline | −0.14 | −0.50 (p < 0.001) | −0.50 (p < 0.001) | |
| FAST4WARD (NCT00548834)21Phase 3 trial: Moderate-to-severe RA patients who have failed ≥1 prior DMARD (n = 220) | |||
| SC CZP or placebo every 4 weeks for 24 weeks. No concomitant DMARD therapy. | |||
| Endpoints at week 24 | Placebo (n = 109) | CZP 400 mg (n = 111) | |
| Primary | ACR20 | 9.3% | 45.5% (p < 0.001) |
| Selected Secondary | ACR50 | 3.7% | 22.7% (p < 0.001) |
| ACR70 | 0% | 5.5% (p ≤ 0.05) | |
| HAQ-DI mean change from baseline | 0.13 | −0.36 (p < 0.001) | |
p values calculated by odds ratios, unless indicated. *by rank analysis. RA, rheumatoid arthritis; MTX, methotrexate; SC, subcutaneous; CZP, certolizumab pegol; wk, week; ACR, American College of Rheumatology; mTSS, modified total Sharp score; HAQ-DI, Health Assessment Questionnaire-Disability Index; DMARD, disease-modifying antirheumatic drug.