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Trial record 1 of 4 for:    cimzia and fistula
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Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas

This study has been withdrawn prior to enrollment.
Information provided by:
UCB Pharma Identifier:
First received: July 18, 2006
Last updated: May 25, 2012
Last verified: May 2012
To investigate the clinical efficacy of certolizumab pegol for fistula closure in Crohn's disease subjects with active draining fistulas.

Condition Intervention Phase
Crohn Disease Drug: Certolizumab pegol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIIB Multicenter, Open Label, Randomized Clinical Trial Evaluating Efficacy of Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor (TNF) in Crohn's Disease Patients With Draining Fistulas.

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Investigation of Clinical efficacy of certolizumab pegol for fistula closure, as measured by the proportion of patients with fistula improvement after 16 weeks of treatment.

Secondary Outcome Measures:
  • Investigation of Clinical efficacy of certolizumab pegol for maintenance of fistula closure.

Enrollment: 0
Study Start Date: January 2007

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Patients with single or multiple fistulas, including perianal and enterocutaneous fistulas for at least 3 months as a complication of Crohn's disease

Exclusion Criteria:

  • Symptomatic obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, abscesses present at screening, current total parenteral nutrition, short bowel syndrome.
  • All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient.
  • Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
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Please refer to this study by its identifier: NCT00354367

Sponsors and Collaborators
UCB Pharma
Study Director: Krassimir Mitchev, MD UCB / Global Medical Affairs
  More Information Identifier: NCT00354367     History of Changes
Other Study ID Numbers: C87058
Study First Received: July 18, 2006
Last Updated: May 25, 2012

Keywords provided by UCB Pharma:
Crohn Disease
Certolizumab pegol

Additional relevant MeSH terms:
Certolizumab Pegol
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on September 19, 2017