PRECiSE 2 Trial Design

A randomized, double-blind, placebo-controlled trial to evaluate the efficacy of CIMZIA in adults with moderate to severe Crohn's disease

Study design represents PRECiSE 2 trial into PRECiSE 3 open-label extension trial.

Pivotal trial*

668 patients (≥18 years of age with Crohn's disease ≥3 months) received CIMZIA 400 mg at Weeks 0, 2, and 4 in open-label induction phase. Responders at Week 6 received CIMZIA subcutaneously every 4 weeks (n=216) or placebo (n=212). Primary end point: response at Week 26 in patients with baseline C-reactive protein ≥10 mg/L.¹

Open-label extension trial^‡

Patients completing the 26-week study could enter an ongoing open-label extension study (PRECiSE 3, n=141). Primary end point: assess the safety of continuous CIMZIA therapy. Secondary end points: obtain data on drug plasma concentrations and antibodies, plus additional effectiveness data.^1,2

*Randomized response and maintenance study.
†Represents moderate to severe disease.
‡Open-label, long-term extension trial for patients completing CIMZIA pivotal trial.

To evaluate the efficacy of CIMZIA in adults with moderate to severe Crohn's disease.¹

Methods

• A 26-week, randomized, double-blind, placebo-controlled trial¹
• Multicenter trial conducted at 147 centers between February 2004 and May 2005¹
• Patients received induction therapy consisting of subcutaneous injections of CIMZIA (400 mg) at Weeks 0, 2, and 4¹
• Patients who responded to induction therapy at Week 6 were randomly assigned to receive either certolizumab or placebo at Weeks 8, 12, 16, 20, 24, and were followed through Week 26¹
• Patients stratified according to baseline C-reactive protein (CRP) levels (≥10 mg per liter or <10 mg per liter), concurrent use of glucocorticoids (yes or no), and concurrent use of immunosuppressive agents
  (yes or no)¹
• Response was defined as a reduction of ≥100 from the baseline score on the Crohn's Disease Activity Index (CDAI)¹

Primary end point

• A clinical response at Week 26 in patients with a baseline CRP level of ≥10 mg per liter¹

Secondary end points

• Response at Week 26¹
• Remission at Week 26 in the intent-to-treat population¹
• Remission in the group with a baseline CRP levels of ≥10 mg per liter¹

Patient population

• Adults with a ≥3-month history of active Crohn's disease (a CDAI score of 220-450)¹
• A broad range of treatment experience¹
  • Concomitant treatment included immunosuppressants only, corticosteroids only, corticosteroids and immunosuppressants, 5-ASAs, and anti-infectives
  • 76% of patients were anti-TNF–naïve and 24% were anti-TNF–experienced^1,3

References:

1. Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al. Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med. 2007;357:239-250.
2. Schreiber S, Panes J, Mason D, Lichtenstein G, Sandborn WJ. Sustained efficacy and tolerability of certolizumab pegol over 18 months: data from PRECiSE 2 and its extension studies (PRECiSE 3 and 4). Poster presented at: American College of Gastroenterology Annual Meeting; October 12-17, 2007; Philadelphia, PA.
3. Colombel JF, Hanauer S, Sandborn WJ, Panes J, McColm J, Schreiber S. Certolizumab pegol administered subcutaneously is effective in anti-TNF naive patients and in patients previously treated with infliximab. Presented at: 14th United European Gastroenterology Week (UEGW); October 21-25, 2006; Berlin, Germany.