Cimzia Versus Mesalamine for Crohn's Recurrence

• Status: Terminated
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Collaborator: UCB Pharma
• Treatments: Certolizumab Pegol; Mesalamine

Criteria

Inclusion Criteria:

• Patients ≥18 years of age or older with Crohn's disease of any phenotype (luminal disease, perforating disease, stricturing disease) with an ileocolic distribution.

• Ileocolic Crohn's disease severe enough to require ileocolectomy (either open or laparoscopic).

Exclusion Criteria:

• Patients younger than 18 years of age, as there is little data on pediatric patients and since the Colorectal Surgery service only treats patients 18 years of age or older.

• Patients undergoing an ileocolectomy for any reason besides Crohn's disease.

• Patients requiring a stoma.

• Patients with short-bowel syndrome.

• Patients who are incarcerated, due to difficulties with frequent clinic visits given their incarceration and transportation issues.

• Patients who received previous anti-TNF therapy from infliximab or adalimumab within three months of surgery, or patients who have a history of a severe hypersensitivity reaction to infliximab or adalimumab

• Patients with a positive PPD and a suspicious finding on a chest x-ray suggestive of tuberculosis, or any patient with a history of tuberculosis.

• Patients who require postoperative therapy besides either mesalamine or certolizumab (steroids, antibiotics, and immunomodulator therapy would not be permitted starting at 4 weeks after ileocolectomy).

• Patients with significant psychiatric disorders (i.e. schizophrenia) and those with significant cognitive disorders, due to the difficulties with this patient group remaining compliant with frequent clinic visits, and due to the difficulty evaluating quality of life measures in these patients.

• Patients with a history of malignancy.

• Patients with a history of any demyelinating neurologic disease or a history of seizures.

• Patients with a history of severe congestive heart failure.

• Patients with a history of hepatitis B or C virus.

• Patients who are pregnant or who become pregnant.

• Involvement in any other clinical studies which use study medications.

• The subject has a condition, which, in the opinion of the investigator, would compromise the study or well-being of the subject or prevent the subject from meeting or performing the study requirements.