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

Crohn Disease Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00354367
• Other study ID #: C87058
• Status: Withdrawn
• Phase: Phase 3
• First received: July 18, 2006
• Last updated: May 25, 2012
• Start date: January 2007

Study information

• Verified date: May 2012
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Certolizumab pegol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Investigation of Clinical efficacy of certolizumab pegol for maintenance of fistula closure.