Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease

Completed · Phase 3

Conditions studied: Crohn's Disease

In brief

The study will continue to assess the safety of certolizumab pegol (CDP870) as well as examine the evolution of long term efficacy in Crohn's disease patients who completed study C87042 \[NCT00308581\]. It will also assess the effect of subcutaneous CDP870 400 mg on direct cost parameters.

Key facts

Study ID

NCT00333788

Run by

UCB Pharma

People needed

233

Starts

2006-10-01

Expected to finish

2010-04-01

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…

• Patients having completed study C87042 [NCT00308581] (previously treated with infliximab)

You may not qualify if…

• Subject withdraw from C87042 [NCT00308581] study
• Subject who received treatment other than certolizumab pegol and other than medications permitted in C87042 [NCT00308581] study
• Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment
• Female patients of childbearing age who are NOT practicing (in the Investigator's opinion) effective birth control. All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every certolizumab pegol administration

Where it is running

• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Louisville, Kentucky, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Lincoln, Nebraska, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Charleston, 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 — Charleston, South Carolina, United States
• Study site — Germantown, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Innsbruck, Austria
• Study site — Vienna, Austria
• Study site — Bonheiden, Belgium
• Study site — Brussels, Belgium
• Study site — Genk, Belgium
• Study site — Ghent, Belgium
• Study site — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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