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This study has been withdrawn prior to enrollment.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

Tracking Information

First Received Date ^ICMJE

July 18, 2006

Last Updated Date

May 25, 2012

Start Date ^ICMJE

January 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00354367 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Investigation of Clinical efficacy of certolizumab pegol for maintenance of fistula closure.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Crohn Disease

Intervention ^ICMJE

Drug: Certolizumab pegol

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00354367

Other Study ID Numbers ^ICMJE

C87058

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

UCB, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Krassimir Mitchev, MD

UCB / Global Medical Affairs

Information Provided By

UCB, Inc.

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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