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

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ClinicalTrials.gov Identifier: NCT00354367
Recruitment Status : Withdrawn
First Posted : July 20, 2006
Last Update Posted : May 28, 2012
Sponsor:
Information provided by:
UCB Pharma

Brief Summary:
To investigate the clinical efficacy of certolizumab pegol for fistula closure in Crohn's disease subjects with active draining fistulas.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: Certolizumab pegol Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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.
Study Start Date : January 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 :
  1. Investigation of Clinical efficacy of certolizumab pegol for maintenance of fistula closure.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354367


Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: Krassimir Mitchev, MD UCB / Global Medical Affairs

ClinicalTrials.gov Identifier: NCT00354367     History of Changes
Other Study ID Numbers: C87058
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: May 2012

Keywords provided by UCB Pharma:
Crohn Disease
Certolizumab pegol
Fistula

Additional relevant MeSH terms:
Fistula
Certolizumab Pegol
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents