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

NCT ID: NCT00354367

Last Updated: 2012-05-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31

Brief Summary

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

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Certolizumab pegol

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Principal Investigators

Krassimir Mitchev, MD

Role: STUDY_DIRECTOR

UCB / Global Medical Affairs

Other Identifiers

C87058

Identifier Type: -

Identifier Source: org_study_id