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

Tracking Information

First Received Date ^ICMJE

July 25, 2006

Last Updated Date

October 26, 2009

Start Date ^ICMJE

January 2007

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

The primary objective is to continue to assess safety of certolizumab pegol as per adverse events reporting.

Change History

Complete list of historical versions of study NCT00356408 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

• To describe the evolution of long term efficacy (through maintenance of clinical remission) in Crohn’s disease patients who have completed COSPAR I study.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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).

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Crohn's Disease

Intervention ^ICMJE

Biological: Certolizumab pegol

Study Arms / Comparison Groups

Experimental: Certolizumab pegol

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

352

Estimated Completion Date

February 2010

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Germany

Administrative Information

NCT ID ^ICMJE

NCT00356408

Responsible Party

Study Director, UCB

Study ID Numbers ^ICMJE

C87065, COSPAR II

Study Sponsor ^ICMJE

UCB, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

Information Provided By

UCB, Inc.

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP