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Cimzia Versus Mesalamine for Crohn's Recurrence

NCT01696942 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-01-12

Study results available
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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).

Conditions

Interventions

DRUG

Cimzia

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

DRUG

Mesalamine

mesalamine 800 mg orally three times daily

Sponsors & Collaborators

  • UCB Pharma

    collaborator INDUSTRY

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • David B Stewart, MD · Milton S. Hershey Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01696942 on ClinicalTrials.gov