A Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo)

Summary

A 26 week study to examine the efficacy, safety and pharmacokinetics of CDP870 in Crohn's disease

Timeline

Start

2003-12

Primary completion

2005-05

Completion

2005-05

Outcome

Mixed primary results

paper Primary end points were the induction of a response at week 6 and a response at both weeks 6 and 26. PMID 17634458 ↗

paper Among patients with a baseline CRP level of at least 10 mg per liter, 37% of patients in the certolizumab group had a response at week 6, as compared with 26% in the placebo group (P=0.04). PMID 17634458 ↗

paper At both weeks 6 and 26, the corresponding values were 22% and 12%, respectively (P=0.05). PMID 17634458 ↗

Publications

• Results Sandborn WJ, Feagan BG, Stoinov S, Honiball PJ, Rutgeerts P, Mason D, Bloomfield R, Schreiber S; PRECISE 1 Study Investigators. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. 2007 Jul 19;357(3):228-38. doi: 10.1056/NEJMoa067594.
• Results Rutgeerts P, Schreiber S, Feagan B, Keininger DL, O'Neil L, Fedorak RN; CDP870 Crohn's Disease Study Group. Certolizumab pegol, a monthly subcutaneously administered Fc-free anti-TNFalpha, improves health-related quality of life in patients with moderate to severe Crohn's disease. Int J Colorectal Dis. 2008 Mar;23(3):289-96. doi: 10.1007/s00384-007-0395-7. Epub 2007 Dec 11.
• Results Reilly MC, Gerlier L, Brabant Y, Brown M. Validity, reliability, and responsiveness of the work productivity and activity impairment questionnaire in Crohn's disease. Clin Ther. 2008 Feb;30(2):393-404. doi: 10.1016/j.clinthera.2008.02.016.
• Lewis JD. Anti-TNF antibodies for Crohn's disease--in pursuit of the perfect clinical trial. N Engl J Med. 2007 Jul 19;357(3):296-8. doi: 10.1056/NEJMe078111. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Certolizumab Pegol	Protein / enzyme biologic	400 mg	Subcutaneous

Indications