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

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).

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Certolizumab pegol Corticosteroids

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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
CDP870: 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Subject withdrawn or discontinued from -059 study under specific conditions.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:	March 31, 2009
ClinicalTrials.gov Identifier:	NCT00356408 History of Changes
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
Immunologic Factors
Ileitis
Gastrointestinal Diseases
Enteritis
Inflammatory Bowel Diseases
Intestinal Diseases

Ileal Diseases
Antibodies
Digestive System Diseases
Crohn Disease
Gastroenteritis
Colitis
Immunoglobulins

Additional relevant MeSH terms:

Immunoglobulin Fab Fragments
Immunologic Factors
Ileitis
Gastrointestinal Diseases
Enteritis
Physiological Effects of Drugs
Inflammatory Bowel Diseases

Intestinal Diseases
Ileal Diseases
Pharmacologic Actions
Digestive System Diseases
Crohn Disease
Gastroenteritis

ClinicalTrials.gov processed this record on July 06, 2009