A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] (PRECiSE 3)
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Certolizumab Pegol, Cimzia, CDP870, CZP
Eligibility Criteria
Inclusion Criteria: Participation in either of the CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] clinical studies in which the subject completed the trial at Week 26. Subjects may have received active or placebo or both treatments in the prior study Subjects must be able to understand the information provided to them and give written informed consent Exclusion Criteria: Any exclusion criterion that would have prevented the subject's participation in the qualifying pivotal study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425], although the criterion that excludes previous participation in a clinical trial of Certolizumab Pegol does not apply. In addition there are no limits on the Clinical Disease Activity Index (CDAI) score at entry
Sites / Locations
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Arms of the Study
Arm 1
Experimental
Certolizumab Pegol
400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.