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Cimzia Versus Mesalamine for Crohn's Recurrence

This study is currently recruiting participants.
Verified February 2013 by Milton S. Hershey Medical Center
Sponsor:
Collaborator:
UCB, Inc.
Information provided by (Responsible Party):
David B. Stewart, MD, FACS, FASCRS, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01696942
First received: September 25, 2012
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  Purpose

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).

Condition Intervention Phase
Crohn's Disease
 Drug: Cimzia
Drug: Mesalamine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Certolizumab Following Ileocolectomy Lowers Endoscopic and Histological Recurrence Rates for Crohn's Disease at One Year Compared to Mesalamine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Clinical recurrence rates of Crohn's disease [ Time Frame: One year following enrollment ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Endoscopic recurrence of Crohn's disease [ Time Frame: One year following enrollment ] [ Designated as safety issue: No ]
    To compare the endoscopic recurrence rates at one year following surgery between patients treated with certolizumab and mesalamine.


Estimated Enrollment: 24
Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cimzia treatment arm
Beginning at 4 weeks after surgery, patients would be randomly assigned using a pulled card method to receive certolizumab at a dose of 400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks thereafter up to 12 months after enrollment.
 Drug: Cimzia
400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks
Other Name: Certolizumab
Active Comparator: Mesalamine treatment arm
Beginning at 4 weeks after surgery, patients would be randomly assigned to receive mesalamine 800 mg orally three times daily for twelve months following enrollment.
 Drug: Mesalamine
mesalamine 800 mg orally three times daily
Other Name: Mesalamine

Detailed Description:

Crohn's disease is an autoimmune, pan-intestinal disease which can affect any portion of the alimentary tract, but which has a preference for the small intestine, the colon, and the anus. It is now well established that Crohn's disease most commonly presents with an ileocolic distribution, followed by involvement of the small intestine, the colon, and the anus. Treatment for Crohn's disease is principally medical, reserving surgery to address complications from the disease which cannot be adequately resolved with medication alone. The single greatest challenge in treating this incurable disease is dealing with its recurrence rate. The cumulative probability of disease recurrence is quite high, with 75% of Crohn's patients requiring abdominal surgery at some point during their life.

Following surgery, recurrence rates are significant, varying depending on the manner in which recurrence is defined. With regard to clinical recurrences, where the recrudescence of the disease is associated with symptoms caused by new intestinal lesions, the recurrence rate is 10-20% per year.In some instances, clinical recurrences can appear within 3 months of surgery. Taking into account the need for additional surgery as defining a "surgical recurrence", reoperation rates for Crohn's disease range from 16% to 65% 10 years after a previous surgery. When recurrence is viewed from the vantage point of evidence of new Crohn's disease activity based on radiographic studies, radiographic recurrences range from 41-60% over the first 10 years following surgery. One of the most common measures of recurrence has become demonstrating evidence of new Crohn's disease activity based on colonoscopy. This endoscopic recurrence has consistently been shown to be as high as 50-75% at 3 months after surgery, and 50-90% at 12 months. It is widely accepted by physicians treating Crohn's patients that the appearance of endoscopic lesions has prognostic significance, as endoscopic evidence of Crohn's disease temporally precedes radiographic, clinical and surgical recurrences.

The role that Cimzia should play in preventing recurrence of Crohn's disease following ileocolectomy for Crohn's disease remains to be determined, as does its relative advantages and disadvantages compared to the use of mesalamine.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696942

Contacts
Contact: David B Stewart, MD 717-531-5164 dstewart@hmc.psu.edu
Contact: Emmanuelle Williams, MD 717531-8741 ewilliams@hmc.psu.edu

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: LeeAnn Smith, RN     717-531-0003 ext 285155     lsmith1@hmc.psu.edu    
Principal Investigator: David B Stewart, MD            
Sub-Investigator: Emmanuelle Williams, MD            
Sub-Investigator: Andrew Tinsley, MD            
Sub-Investigator: Walter A Koltun, MD            
Sub-Investigator: Evangelos Messaris, MD            
Sponsors and Collaborators
Milton S. Hershey Medical Center
UCB, Inc.
Investigators
Principal Investigator: David B Stewart, MD Milton S. Hershey Medical Center
  More Information

Publications:

Responsible Party: David B. Stewart, MD, FACS, FASCRS, Assistant Professor of Surgery, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01696942     History of Changes
Other Study ID Numbers: 36497
Study First Received: September 25, 2012
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Crohn's disease
certolizumab
mesalamine
recurrence

Additional relevant MeSH terms:
Crohn Disease
Recurrence
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013