Overview

Cimzia Versus Mesalamine for Crohn's Recurrence

Status:
Terminated
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 4
Details
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborator:
UCB Pharma
Treatments:
Certolizumab Pegol
Mesalamine