Extension Study to Evaluate Safety, Efficacy, and Corticosteroid Sparing Effect of Certolizumab in Patients With Crohn's Disease. - Full Text View

Purpose

This is an open-label extension study designed to measure the safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease previously enrolled in COSPAR I.

Condition	Intervention	Phase
Crohn's Disease	Biological: Certolizumab pegol	Phase III

Genetics Home Reference related topics:

Crohn disease

MedlinePlus related topics:

Crohn's Disease

ChemIDplus related topics:

Corticosteroids Certolizumab pegol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title:	C87065 (COSPAR II): An Open-Label, Multi-Center Trial to Examine the Long Term Safety, Efficacy, and Corticosteroid-Sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease Previously Enrolled in the Trial C87059 (COSPAR I).

Further study details as provided by UCB:

Primary Outcome Measures:

The primary objective is to continue to assess safety of certolizumab pegol as per adverse events reporting. [ Time Frame: duration of the trial ]

Secondary Outcome Measures:

To describe the evolution of long term efficacy (through maintenance of clinical remission) in Crohn's disease patients who have completed COSPAR I study. [ Time Frame: Duration of the trial ]

Estimated Enrollment:	352
Study Start Date:	January 2007
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Certolizumab pegol	Biological: Certolizumab pegol 400 mg liduid CP administered as 2 subcutaneous injections of 200 mg every 4 weeks for the duration of the trial

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients previously enrolled in C87059.

Exclusion Criteria:

Subject withdrawn or discontinued from -059 study under specific conditions.
Subject who received treatment other than study medication and other than medications permitted in the -059 study.
Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356408

Contacts


Contact: UCB Clinical Trial Call Center	+1 877 822 9493

Show 67 Study 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:	C87065, COSPAR II
First Received:	July 25, 2006
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00356408
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Germany: Paul-Ehrlich-Institut; Canada: Ethics Review Committee

Keywords provided by UCB:

certolizumab pegol

Crohn's Disease

Inflammatory Bowel Diseases

Ileitis

Colitis

Enteritis

Ileocolitits

Study placed in the following topic categories:

Digestive System Diseases

Gastrointestinal Diseases

Ileitis

Enteritis

Crohn Disease

Inflammatory Bowel Diseases

Gastroenteritis

Intestinal Diseases

Colitis

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00356408