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Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00354367
First received: July 18, 2006
Last updated: May 25, 2012
Last verified: May 2012
History of Changes
  Purpose

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: 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:

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354367

Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: Krassimir Mitchev, MD UCB / Global Medical Affairs
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00354367     History of Changes
Other Study ID Numbers: C87058
Study First Received: July 18, 2006
Last Updated: May 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Crohn Disease
Certolizumab pegol
Fistula

Additional relevant MeSH terms:
Crohn Disease
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Pathological Conditions, Anatomical
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013