Mucosal Healing Study - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00297648

Purpose

The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in Crohn's disease.

Condition	Intervention	Phase
Crohn Disease	Biological: Certolizumab pegol	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Endoscopy

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease

Further study details as provided by UCB:

Primary Outcome Measures:

Efficacy of certolizumab pegol will be assessed using the CDEIS (Crohn's Disease Endoscopic Index of Severity) score at week 10 compared to baseline. [ Time Frame: 10 weeks ]

Secondary Outcome Measures:

Efficacy evaluated as improvement in the CDAI and histological Crohn's disease score at week 10; Safety and tolerability of certolizumab pegol. [ Time Frame: 52 weeks ]

Enrollment:	89
Study Start Date:	February 2006
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Certolizumab pegol 200mg/vial, 400 mg at week 0, 2 and 4 and then 400 mg every 4 weeks.

Eligibility

Criteria

Inclusion Criteria:

Patients suffering from active Crohn's disease with CDAI ≥ 220 and ≤ 450 and typical pathological changes in the intestinal mucosa at the baseline.

Exclusion Criteria:

Obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, 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: NCT00297648

Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	C87043, EudraCT Number 2005-003977-25
Study First Received:	February 27, 2006
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00297648
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by UCB:

Certolizumab pegol
Crohn disease
Mucosal healing

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

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009