Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT00349752

Run by

UCB Pharma

People needed

174

Starts

2006-11-01

Expected to finish

2009-07-01

Last updated by the study team

2018-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Study site — Montgomery, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — La Jolla, California, United States
• Study site — Oceanside, California, United States
• Study site — Orange, California, United States
• Study site — Palo Alto, California, United States
• Study site — Roseville, California, United States
• Study site — Golden, Colorado, United States
• Study site — Clearwater, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — North Miami Beach, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Bloomington, Indiana, United States
• Study site — Topeka, Kansas, United States
• Study site — Bowling Green, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Metairie, Louisiana, United States
• Study site — Annapolis, Maryland, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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