REALISTIC: A 12-week trial in a broad RA population, more typical of patients seen in routine clinical practice

REALISTIC study design12

Graph representing REALISTIC study design

The REALISTIC trial was a phase 3b trial conducted to investigate the efficacy and safety of certolizumab pegol (CZP) in a broad population of patients with active RA (at least 5 tender and at least 4 swollen joints). In this 12-week, double-blind period of the phase 3b trial, RA patients with inadequate response to at least 1 DMARD were randomized 4:1 to CZP (400 mg at weeks 0, 2, and 4, followed by 200 mg every 2 weeks) or placebo (every 2 weeks) plus current therapy. Patients were stratified by prior TNF inhibitor use, disease duration (<2 years vs ≥2 years), and concomitant use of methotrexate (MTX) (yes/no). Patients with prior TNF inhibitor experience (n=400 of 1063 or 37.6%) could have been treated with up to 2 TNF inhibitors and could have discontinued their prior TNF inhibitor use for lack of efficacy, intolerance, or other reasons. The primary endpoint of REALISTIC was the American College of Rheumatology 20% improvement (ACR20) response rate at week 12.12

Selected inclusion criteria

  • Unsatisfactory response or intolerance to at least 1 nonbiological DMARD
  • Could be previously treated with 2 or fewer TNF inhibitors (with defined washout period)
  • At least 5 tender and at least 4 swollen joints (28-joint count)

Baseline stratification demographics

  • Prior TNF inhibitor use for CIMZIA vs placebo: 320 (37.6%) vs 80 (37.7%)
  • Concomitant use of methotrexate (MTX): 589 (69.2%) vs 143 (67.5%)
  • Disease duration <2 years: 206 (24.2%) vs 50 (23.6%)