PRECiSE 2 study design1,14
The safety and efficacy of CIMZIA were evaluated in this randomized, double-blind, placebo-controlled trial in 668 adults with moderately to severely active CD (defined as a Crohn’s Disease Activity Index [CDAI] score of 220-450 points). Patients received open-label CIMZIA 400 mg subcutaneously at weeks 0, 2, and 4. At week 6, patients with a clinical response (defined as a decrease in CDAI score ≥100 points) were randomized to receive CIMZIA 400 mg or placebo every 4 weeks. The primary endpoint was clinical response at week 26 in patients with a baseline C-reactive protein (CRP) ≥10 mg/L. Secondary endpoints for the overall population irrespective of baseline CRP included the proportion of patients with clinical response at week 26, time to disease progression up to and including week 26, the proportion of patients with clinical remission (defined as a CDAI score ≤150 points) at week 26, and the proportion of patients with Inflammatory Bowel Disease Questionnaire (IBDQ) response (defined as an increase of ≥16 points from the baseline IBDQ score) at week 26.