Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease
NCT ID: NCT00356408
Last Updated: 2018-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
106 participants
INTERVENTIONAL
2007-01-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Birmingham, Alabama, United States
Montgomery, Alabama, United States
La Jolla, California, United States
Oceanside, California, United States
Palo Alto, California, United States
Roseville, California, United States
Lakewood, Colorado, United States
Clearwater, Florida, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
North Miami Beach, Florida, United States
Marietta, Georgia, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Bloomington, Indiana, United States
Davenport, Iowa, United States
Topeka, Kansas, United States
Bowling Green, Kentucky, United States
Louisville, Kentucky, United States
Metairie, Louisiana, United States
Annapolis, Maryland, United States
Newton, Massachusetts, United States
Chesterfield, Michigan, United States
Dearborn, Michigan, United States
Troy, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Kansas City, Missouri, United States
Mexico, Missouri, United States
New York, New York, United States
Syracuse, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Tulsa, Oklahoma, United States
Columbia, South Carolina, United States
Germantown, Tennessee, United States
Austin, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Chesapeake, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Monroe, Wisconsin, United States
Edmonton, Alberta, Canada
Abbottsford, British Columbia, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Saskatoon, Saskatchewan, Canada
Calgary, , Canada
Frankfurt, , Germany
Heidelberg, , Germany
Jena, , Germany
Rostock, , Germany
Ulm, , Germany
Countries
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Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2006-003871-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C87065
Identifier Type: -
Identifier Source: org_study_id
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