Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease

Last updated: July 10, 2018
Sponsor: UCB Pharma
Overall Status: Terminated

Phase

3

Condition

Inflammatory Bowel Disease

Crohn's Disease

Colic

Treatment

N/A

Clinical Study ID

NCT00349752
C87059
2006-003870-88
  • Ages > 18
  • All Genders

Study Summary

The current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe Crohn's disease. Subjects had to be in remission (CDAI<=150) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women

  • Age 18 years or older with moderate to severe Crohn's disease (Crohn's DiseaseActivity Index (CDAI) score of ≥ 220 ≤450)

Exclusion

Exclusion Criteria:

  • Active or draining fistula present at screening

  • Lactating and/or pregnant female subjects

  • A history of any health condition that could potentially interfere with the diseaseand/or the treatment

  • A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinalproduct

  • Any other condition which in the Investigator's judgment would make the patientunsuitable 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 monthsprior to Visit 0

Study Design

Total Participants: 174
Study Start date:
November 01, 2006
Estimated Completion Date:
July 31, 2009

Connect with a study center

  • Calgary, Alberta
    Canada

    Site Not Available

  • Edmonton, Alberta
    Canada

    Site Not Available

  • Abbotsford, British Columbia
    Canada

    Site Not Available

  • Vancouver, British Columbia
    Canada

    Site Not Available

  • Winnipeg, Manitoba
    Canada

    Site Not Available

  • 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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  • Frankfurt,
    Germany

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  • Heidleberg,
    Germany

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  • Jena,
    Germany

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  • Magdeburg,
    Germany

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  • Ulm,
    Germany

    Site Not Available

  • Birmingham, Alabama
    United States

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  • Montgomery, Alabama
    United States

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  • Tucson, Arizona
    United States

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  • La Jolla, California
    United States

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  • Oceanside, California
    United States

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  • Orange, California
    United States

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  • Palo Alto, California
    United States

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  • Roseville, California
    United States

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  • Golden, 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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  • Sarasota, Florida
    United States

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  • Winter Park, 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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  • 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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  • Rochester, Minnesota
    United States

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  • Ocean Springs, Mississippi
    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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  • empty

    Cincinatti, Ohio
    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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  • Irving, 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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  • Madison, Wisconsin
    United States

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  • Milwaukee, Wisconsin
    United States

    Site Not Available

  • Monroe, Wisconsin
    United States

    Site Not Available

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