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

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

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

Drug Information available for: Certolizumab pegol Corticosteroids

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:	July 2010
Estimated Primary Completion Date:	July 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Subject withdrawn or discontinued from -059 study under specific conditions.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

Show 63 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	C87065, COSPAR II
Study First Received:	July 25, 2006
Last Updated:	November 17, 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:

Immunoglobulin Fab Fragments
Crohn's disease
Ileitis
Gastrointestinal Diseases
Enteritis
Inflammatory Bowel Diseases
Intestinal Diseases

Ileal Diseases
Antibodies
Digestive System Diseases
Crohn Disease
Gastroenteritis
Colitis
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009