Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn Disease

In brief

The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.

Key facts

Study ID

NCT00552058

Run by

UCB Pharma

People needed

439

Starts

2008-03-01

Expected to finish

2009-11-01

Last updated by the study team

2018-08-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• male/female
• 18 - 75 years inclusive
• diagnosis of Crohn's disease confirmed
• moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)
• no previous treatment with anti-tumor necrosis factor (anti-TNF) medications

You may not qualify if…

• previous participation in a certolizumab pegol study
• general exclusion criteria as common for studies in this indication

Where it is running

• Study site — Colorado Springs, Colorado, United States
• Study site — Lakewood, Colorado, United States
• Study site — Littleton, Colorado, United States
• Study site — Hollywood, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Louisville, Kentucky, United States
• Study site — Metairie, Louisiana, United States
• Study site — Monroe, Louisiana, United States
• Study site — Annapolis, Maryland, United States
• Study site — Towson, Maryland, United States
• Study site — Chesterfield, Michigan, United States
• Study site — West Bloomfield, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Lancaster, Pennsylvania, United States
• Study site — Germantown, Tennessee, United States
• Study site — Norfolk, Virginia, United States
• Study site — Seattle, Washington, United States
• Study site — Concord, New South Wales, Australia
• Study site — Pell City, Alabama, United States

Full record on ClinicalTrials.gov

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