Cimzia Versus Mesalamine for Crohn's Recurrence

Summary

Hypothesis: Cimzia provides superior reduction in endoscopic and clinical recurrence rates compared to mesalamine in the treatment of Crohn's disease one-year following ileocolectomy for Crohn's disease. 1. To evaluate the difference in clinical recurrence rates between certolizumab and mesalamine after 4 weeks, 3 months, 6 months, 9 months, and 12 months of use following ileocolectomy for Crohn's disease using the Crohn's Disease Activity Index (CDAI). 2. To compare the endoscopic recurrence rates at one year following surgery between patients treated with certolizumab and mesalamine. 3. To compare medication side-effects and tolerance of therapy, including the need to interrupt therapy due to side-effects, the incidence of opportunistic infections, and a general assessment of each patient's health and well-being using the short-form 36 (SF-36).

Timeline

Start

2013-02

Primary completion

2016-06

Completion

2016-06

Publications

• Background Whelan G, Farmer RG, Fazio VW, Goormastic M. Recurrence after surgery in Crohn's disease. Relationship to location of disease (clinical pattern) and surgical indication. Gastroenterology. 1985 Jun;88(6):1826-33. doi: 10.1016/0016-5085(85)90007-1.
• Background Mekhjian HS, Switz DM, Watts HD, Deren JJ, Katon RM, Beman FM. National Cooperative Crohn's Disease Study: factors determining recurrence of Crohn's disease after surgery. Gastroenterology. 1979 Oct;77(4 Pt 2):907-13. No abstract available.
• Background Kyle J. Prognosis after ileal resection for Crohn's disease. Br J Surg. 1971 Oct;58(10):735-7. doi: 10.1002/bjs.1800581006. No abstract available.
• Background Lennard-Jones JE, Stalder GA. Prognosis after resection of chronic regional ileitis. Gut. 1967 Aug;8(4):332-6. doi: 10.1136/gut.8.4.332. No abstract available.
• Background Greenstein AJ, Sachar DB, Pasternack BS, Janowitz HD. Reoperation and recurrence in Crohn's colitis and ileocolitis; Crude and cumulative rates. N Engl J Med. 1975 Oct 2;293(14):685-90. doi: 10.1056/NEJM197510022931403.
• Background Regueiro M, Schraut W, Baidoo L, Kip KE, Sepulveda AR, Pesci M, Harrison J, Plevy SE. Infliximab prevents Crohn's disease recurrence after ileal resection. Gastroenterology. 2009 Feb;136(2):441-50.e1; quiz 716. doi: 10.1053/j.gastro.2008.10.051. Epub 2008 Oct 31.
• Background Cottone M, Mocciaro F, Orlando A. Infliximab prevents Crohn's disease recurrence after ileal resection. Expert Rev Gastroenterol Hepatol. 2009 Jun;3(3):231-4. doi: 10.1586/egh.09.13. No abstract available.
• Background Schreiber S. Certolizumab pegol for the treatment of Crohn's disease. Ther Adv Gastroenterol. 2011 Nov;4(6):375-89. doi: 10.1177/1756283X11413315.
• Background Sandborn WJ, Schreiber S, Feagan BG, Rutgeerts P, Younes ZH, Bloomfield R, Coteur G, Guzman JP, D'Haens GR. Certolizumab pegol for active Crohn's disease: a placebo-controlled, randomized trial. Clin Gastroenterol Hepatol. 2011 Aug;9(8):670-678.e3. doi: 10.1016/j.cgh.2011.04.031. Epub 2011 May 13.
• Background Feagan BG, Sandborn WJ, Wolf DC, Coteur G, Purcaru O, Brabant Y, Rutgeerts PJ. Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab. Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi: 10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.

Drugs

Indications