Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00354367

Purpose

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

Condition	Intervention	Phase
Crohn Disease	Drug: Certolizumab pegol	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Fistulas

Drug Information available for: Immunoglobulins Globulin, Immune Certolizumab pegol Tumor Necrosis Factors

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
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.

Further study details as provided by UCB:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	200
Study Start Date:	January 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354367

Sponsors and Collaborators

UCB

Investigators

Study Director:

Krassimir Mitchev, MD

UCB / Global Medical Affairs

More Information

Study ID Numbers:	C87058
Study First Received:	July 18, 2006
Last Updated:	November 6, 2007
ClinicalTrials.gov Identifier:	NCT00354367
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB:

Crohn Disease
Certolizumab pegol
Fistula

Study placed in the following topic categories:

Immunoglobulin Fab Fragments
Antibodies
Necrosis
Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases
Immunoglobulins
Fistula

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009