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Use of Certolizumab Following Ileocolectomy Lowers Endoscopic and Histological Recurrence Rates for Crohn's Disease at One Year Compared to Mesalamine
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).
Details
| Lead sponsor | Milton S. Hershey Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 10 |
| Start date | 2013-02 |
| Completion | 2016-06 |
Conditions
- Crohn's Disease
Interventions
- Cimzia
- Mesalamine
Primary outcomes
- Clinical Recurrence Rates of Crohn's Disease — 4 weeks, 3 months, 6 months, 9 months, and 12 months
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). CDAI scores of 150 or greater are considered a recurrence.
Countries
United States