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

Status:	Completed
Conditions:	Gastrointestinal, Crohns Disease
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - Any
Updated:	8/9/2018
Start Date:	October 2006
End Date:	April 2010

Open Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study.

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.

Inclusion Criteria:

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

Exclusion Criteria:

- 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

We found this trial at

sites

Clinical Trial Facility in Portland Oregon

Portland, Oregon

from

Portland, OR