Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease
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 C87059 (COSPAR I, NCT00349752).
2 other identifiers
interventional
106
3 countries
63
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2007
Typical duration for phase_3
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2006
CompletedFirst Posted
Study publicly available on registry
July 26, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
May 25, 2011
CompletedAugust 9, 2018
April 1, 2011
3.1 years
July 25, 2006
February 23, 2011
July 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of at Least One Treatment-emergent Adverse Event 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 Outcomes (1)
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.
Week 34 in this study
Study Arms (1)
CDP870 400 mg
EXPERIMENTALCertolizumab 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients previously enrolled in C87059 (COSPAR I, NCT00349752)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (63)
Unknown Facility
Birmingham, Alabama, United States
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Montgomery, Alabama, United States
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La Jolla, California, United States
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Oceanside, California, United States
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Palo Alto, California, United States
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Roseville, California, United States
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Lakewood, Colorado, United States
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Clearwater, Florida, United States
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Gainesville, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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North Miami Beach, Florida, United States
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Marietta, Georgia, United States
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Savannah, Georgia, United States
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Chicago, Illinois, United States
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Bloomington, Indiana, United States
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Davenport, Iowa, United States
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Topeka, Kansas, United States
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Bowling Green, Kentucky, United States
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Louisville, Kentucky, United States
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Metairie, Louisiana, United States
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Annapolis, Maryland, United States
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Newton, Massachusetts, United States
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Chesterfield, Michigan, United States
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Dearborn, Michigan, United States
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Troy, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Kansas City, Missouri, United States
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Mexico, Missouri, United States
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New York, New York, United States
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Syracuse, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Tulsa, Oklahoma, United States
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Columbia, South Carolina, United States
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Germantown, Tennessee, United States
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Austin, Texas, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Chesapeake, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Monroe, Wisconsin, United States
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Edmonton, Alberta, Canada
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Abbottsford, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Saskatoon, Saskatchewan, Canada
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Calgary, Canada
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Frankfurt, Germany
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Heidelberg, Germany
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Jena, Germany
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Rostock, Germany
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Ulm, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB (Study Director)
- Organization
- UCB Clinical Trial Call Center
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
July 25, 2006
First Posted
July 26, 2006
Study Start
January 1, 2007
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
August 9, 2018
Results First Posted
May 25, 2011
Record last verified: 2011-04