Cimzia Versus Mesalamine for Crohn's Recurrence

NCT01696942 | Terminated Phase 4 Results DMC

• 1 other identifier: 36497
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.To compare the endoscopic recurrence rates at one year following surgery between patients treated with certolizumab and mesalamine.
3. 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).

Conditions

Crohn's Disease

Keywords

Crohn's disease; certolizumab; mesalamine; recurrence

Outcome Measures

Primary Outcomes (1)

• Clinical Recurrence Rates of Crohn's Disease

  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.

  4 weeks, 3 months, 6 months, 9 months, and 12 months

Secondary Outcomes (1)

• Number of Participants With Endoscopic Recurrence of Crohn's Disease

  One year following enrollment

Study Arms (2)

Cimzia treatment arm

EXPERIMENTAL

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

Mesalamine treatment arm

ACTIVE COMPARATOR

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

Interventions

Cimzia DRUG

400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks

Also known as: Certolizumab

Cimzia treatment arm

Mesalamine DRUG

mesalamine 800 mg orally three times daily

Mesalamine treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• UCB Pharma: collaborator

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (10)

• Whelan G, Farmer RG, Fazio VW, Goormastic M. Recurrence after surgery in Crohn's disease. Relationship to location of disease (clinical pattern) and surgical indication. Gastroenterology. 1985 Jun;88(6):1826-33. doi: 10.1016/0016-5085(85)90007-1.

  PMID: 3996839 BACKGROUND

• Mekhjian HS, Switz DM, Watts HD, Deren JJ, Katon RM, Beman FM. National Cooperative Crohn's Disease Study: factors determining recurrence of Crohn's disease after surgery. Gastroenterology. 1979 Oct;77(4 Pt 2):907-13. No abstract available.

  PMID: 467942 BACKGROUND

• Kyle J. Prognosis after ileal resection for Crohn's disease. Br J Surg. 1971 Oct;58(10):735-7. doi: 10.1002/bjs.1800581006. No abstract available.

  PMID: 5097949 BACKGROUND

• Lennard-Jones JE, Stalder GA. Prognosis after resection of chronic regional ileitis. Gut. 1967 Aug;8(4):332-6. doi: 10.1136/gut.8.4.332. No abstract available.

  PMID: 6039720 BACKGROUND

• Greenstein AJ, Sachar DB, Pasternack BS, Janowitz HD. Reoperation and recurrence in Crohn's colitis and ileocolitis; Crude and cumulative rates. N Engl J Med. 1975 Oct 2;293(14):685-90. doi: 10.1056/NEJM197510022931403.

  PMID: 1160935 BACKGROUND

• Regueiro M, Schraut W, Baidoo L, Kip KE, Sepulveda AR, Pesci M, Harrison J, Plevy SE. Infliximab prevents Crohn's disease recurrence after ileal resection. Gastroenterology. 2009 Feb;136(2):441-50.e1; quiz 716. doi: 10.1053/j.gastro.2008.10.051. Epub 2008 Oct 31.

  PMID: 19109962 BACKGROUND

• Cottone M, Mocciaro F, Orlando A. Infliximab prevents Crohn's disease recurrence after ileal resection. Expert Rev Gastroenterol Hepatol. 2009 Jun;3(3):231-4. doi: 10.1586/egh.09.13. No abstract available.

  PMID: 19485805 BACKGROUND

• Schreiber S. Certolizumab pegol for the treatment of Crohn's disease. Therap Adv Gastroenterol. 2011 Nov;4(6):375-89. doi: 10.1177/1756283X11413315.

  PMID: 22043230 BACKGROUND

• Sandborn WJ, Schreiber S, Feagan BG, Rutgeerts P, Younes ZH, Bloomfield R, Coteur G, Guzman JP, D'Haens GR. Certolizumab pegol for active Crohn's disease: a placebo-controlled, randomized trial. Clin Gastroenterol Hepatol. 2011 Aug;9(8):670-678.e3. doi: 10.1016/j.cgh.2011.04.031. Epub 2011 May 13.

  PMID: 21642014 BACKGROUND

• Feagan BG, Sandborn WJ, Wolf DC, Coteur G, Purcaru O, Brabant Y, Rutgeerts PJ. Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab. Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi: 10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.

  PMID: 21223344 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Recurrence

Interventions

Certolizumab Pegol; Mesalamine

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Results Point of Contact

• Title: Dr. David Stewart
• Organization: Milton S. Hershey Medical Center

dstewart@pennstatehealth.psu.edu

717-531-0003

Study Officials

• David B Stewart, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: October 2, 2012
• Study Start: February 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 12, 2018
• Results First Posted: October 10, 2017

Record last verified: 2017-12

Locations

US (1)