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

Phase 3

Withdrawn

• Conditions: Crohn Disease

• Registration Number: NCT00354367
• Lead Sponsor: UCB Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-18
• Study First Submitted QC: 2006-07-18
• Study First Posted: 2006-07-20
• Study Start: 2007-01
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-25
• Last Update Posted: 2012-05-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Investigation of Clinical efficacy of certolizumab pegol for maintenance of fistula closure.