Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease
NCT ID: NCT00349752
Last Updated: 2018-08-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
174 participants
INTERVENTIONAL
2006-11-30
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Certolizumab pegol 400 mg
Certolizumab pegol 400 mg
certolizumab pegol 400 mg
Certolizumab pegol 400 mg provided in solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.
Placebo
Placebo
Placebo
Placebo (commercially available sodium chloride 0.9% (preservative free)) provided for subcutaneous injection in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.
Interventions
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certolizumab pegol 400 mg
Certolizumab pegol 400 mg provided in solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.
Placebo
Placebo (commercially available sodium chloride 0.9% (preservative free)) provided for subcutaneous injection in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older with moderate to severe Crohn's disease (Crohn's Disease Activity Index (CDAI) score of ≥ 220 ≤450)
Exclusion Criteria
* Lactating and/or pregnant female subjects
* A history of any health condition that could potentially interfere with the disease and/or the treatment
* A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product
* Any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study
* History of drug or alcohol abuse in the prior year
* Receipt of any experimental therapy within or outside a clinical trial in the 3 months prior to Visit 0
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
Tucson, Arizona, United States
La Jolla, California, United States
Oceanside, California, United States
Orange, California, United States
Palo Alto, California, United States
Roseville, California, United States
Golden, 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
Sarasota, Florida, United States
Winter Park, Florida, United States
Marietta, Georgia, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Bloomington, Indiana, 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
Rochester, Minnesota, United States
Ocean Springs, Mississippi, 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
Irving, 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
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Monroe, Wisconsin, United States
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Abbotsford, British Columbia, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Saskatoon, Saskatchewan, Canada
Frankfurt, , Germany
Heidleberg, , Germany
Jena, , Germany
Magdeburg, , 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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2006-003870-88
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C87059
Identifier Type: -
Identifier Source: org_study_id
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