Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab

Key facts

Study ID

NCT00308581

Run by

UCB Pharma

People needed

539

Starts

2006-04-01

Expected to finish

2008-04-01

Last updated by the study team

2018-08-07

Who can join

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

You may qualify if…

• Subjects with Crohn's Disease
• Previous treatment failure to Infliximab (intolerance and/or no response)

You may not qualify if…

• Obstructive intestinal strictures
• Recent bowel resection
• Proctocolectomy or total colectomy
• Current total parenteral nutrition
• Short bowel syndrome
• All concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
• Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial

Where it is running

• Study site — London, United Kingdom
• Study site — Nottingham, United Kingdom
• Study site — Oxford, United Kingdom
• Study site — Sheffield, United Kingdom
• Study site — San Francisco, California, United States
• Study site — Gainesville, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Rochester, Minnesota, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Great Neck, New York, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Portland, Oregon, United States
• Study site — Edinburgh, United Kingdom

Full record on ClinicalTrials.gov

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