Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease

NCT00349752 | Terminated Phase 3 Results

• 2 other identifiers: C870592006-003870-88
• Study Type: interventional
• Target: 174
• Locations: 3 countries
• Sites: 68

Brief 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.

Conditions

Crohn's Disease

Keywords

certolizumab pegol; Cimzia; Crohn's Disease; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38

  The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.

  Week 38

Secondary Outcomes (10)

• Percentage of Subjects With Continuous Remission Off Steroids at Week 38

  Week 38

• Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38

  Week 38

• Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period

  During the 38-week double-blind treatment period

• Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period

  Over the 38-week double-blind treatment period

• Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period

  Over the 48-week study period

Study Arms (2)

Certolizumab pegol 400 mg

EXPERIMENTAL

Certolizumab pegol 400 mg

Biological: certolizumab pegol 400 mg

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

certolizumab pegol 400 mg BIOLOGICAL

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.

Also known as: Cimzia, CDP870, CZP

Certolizumab pegol 400 mg

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 disease and/or the treatment
• A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product
• 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

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (68)

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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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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

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Monroe, Wisconsin, United States

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Abbotsford, 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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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

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Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Limitations and Caveats

Recruitment was stopped early due to slow enrolment of this population. With no safety concerns, the study continued normally for the 174 subjects already recruited. Results should be treated with caution due to the early termination of this study.

Results Point of Contact

• Title: Study Director
• Organization: UCB Clinical Trial Call Center

+1 877 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 10, 2006
• Study Start: November 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: August 9, 2018
• Results First Posted: December 1, 2010

Record last verified: 2010-10

Locations

CA (9); DE (5); US (54)