Cimzia Versus Mesalamine for Crohn's Recurrence
Condition: Crohn's Disease
MeSH terms: Crohn Disease; Recurrence
Intervention: Cimzia; Mesalamine
Intervention description: 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks; mesalamine 800 mg orally three times daily
Intervention MeSH terms: Mesalamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Crohn's disease; certolizumab; mesalamine; 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).
    

Eligibility 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.