PRECiSE 1 Trial Design*

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

Pivotal trial*

662 patients with active Crohn's disease were randomized to receive CIMZIA 400 mg or placebo at Weeks 0, 2, and 4 and then every 4 weeks to Week 26. Clinical response defined as ≥100-point reduction in Crohn's Disease Activity Index (CDAI) score and clinical remission as CDAI score ≤150 points.²

Open-label extension trial^‡

Patients completing the 26-week study could enter an ongoing open-label extension study (PRECiSE 3;n=188). 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.³

*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.²

Methods

• A 26-week, randomized, double-blind, placebo-controlled trial²
• Multicenter trial conducted at 171 centers between December 2003 and May 2005²
• Patients stratified according to baseline C-reactive protein (CRP) levels and received either CIMZIA (400 mg) or placebo subcutaneously at Weeks 0, 2, and 4 and then every 4 weeks²
• Patients could receive concomitant therapy with stable doses of 5-aminosalicylates, prednisolone or its equivalent (at a dose of 30 mg per day or less), azathioprine, 6-mercaptopurine, methotrexate, or antibiotics²

Primary end points

A decrease of at least 100 points in the CDAI score at Week 6 and at both Weeks 6 and 26 in patients with a baseline serum CRP level of ≥10 mg per liter.¹

Secondary end points

• Remission at Week 6 and at both Weeks 6 and 26 in patients with a baseline serum CRP level of ≥10 mg per liter²
• A decrease of at least 100 points in the CDAI score and remission at Week 6 and at both Weeks 6 and 26 among all patients, regardless of CRP concentration²

Patient population

• Adults with a ≥3-month history of active Crohn's disease (a CDAI score of 220-450)²
• A broad range of treatment experience²
  • Concomitant treatment included immunosuppressants only, corticosteroids only, corticosteroids and immunosuppressants, 5-ASAs, and anti-infectives²
  • 72% of patients were anti–TNF–naïve and 28% were anti-TNF–experienced

References:

1. Data on file. Smyrna, GA: UCB, Inc.
2. Sandborn WJ, Feagan BG, Stoinov S, et al; for the PRECiSE 1 Study Investigators. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. 2007;375:228-238.
3. 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.