Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease (COSPAR II)

July 10, 2018 updated by: UCB Pharma

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 C87059 (COSPAR I, NCT00349752).

This is an open-label extension study designed to measure the safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol (CDP870) in patients with moderate to severe Crohn's disease previously enrolled in C87059 (COSPAR I, NCT00349752).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Calgary, Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Abbottsford, British Columbia, Canada
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
  • Germany
      • Frankfurt, Germany
      • Heidelberg, Germany
      • Jena, Germany
      • Rostock, Germany
      • Ulm, Germany
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Montgomery, Alabama, United States
    • California
      • La Jolla, California, United States
      • Oceanside, California, United States
      • Palo Alto, California, United States
      • Roseville, California, United States
    • Colorado
      • Lakewood, Colorado, United States
    • Florida
      • Clearwater, Florida, United States
      • Gainesville, Florida, United States
      • Hialeah, Florida, United States
      • Jacksonville, Florida, United States
      • North Miami Beach, Florida, United States
    • Georgia
      • Marietta, Georgia, United States
      • Savannah, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Bloomington, Indiana, United States
    • Iowa
      • Davenport, Iowa, United States
    • Kansas
      • Topeka, Kansas, United States
    • Kentucky
      • Bowling Green, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Metairie, Louisiana, United States
    • Maryland
      • Annapolis, Maryland, United States
    • Massachusetts
      • Newton, Massachusetts, United States
    • Michigan
      • Chesterfield, Michigan, United States
      • Dearborn, Michigan, United States
      • Troy, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
      • Rochester, Minnesota, United States
    • Missouri
      • Kansas City, Missouri, United States
      • Mexico, Missouri, United States
    • New York
      • New York, New York, United States
      • Syracuse, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Dayton, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • South Carolina
      • Columbia, South Carolina, United States
    • Tennessee
      • Germantown, Tennessee, United States
    • Texas
      • Austin, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Chesapeake, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States
      • Monroe, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients previously enrolled in C87059 (COSPAR I, NCT00349752)

Exclusion Criteria:

  • Subject withdrawn or discontinued from C87059 (COSPAR I, NCT00349752) study under specific conditions
  • Subject who received treatment other than study medication and other than medications permitted in C87059 (COSPAR I, NCT00349752)
  • Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CDP870 400 mg
Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
Biological: Certolizumab pegol

Certolizumab pegol (CDP870), an anti-tumor necrosis factor (TNF)α, humanized antibody Fab' fragment - polyethylene glycol conjugate, solution for injection, in 10 mM sodium acetate buffer and 125 mM sodium chloride, pH 4.7, supplied in 3 mL vials with a fill of 1.4 mL (an extractable volume of 1 mL corresponds to a dose of 200 mg).

Dosing is every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2.

Other Names:
  • Cimzia
  • CZP
  • CDP870

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)
Time Frame: During this study (maximum 122 weeks)
Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.
During this study (maximum 122 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids.
Time Frame: Week 34 in this study
Crohn's disease activity index (CDAI) is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in disease remission at Week 34.
Week 34 in this study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

July 25, 2006

First Submitted That Met QC Criteria

July 25, 2006

First Posted (Estimate)

July 26, 2006

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C87065
  • 2006-003871-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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