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]



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:8/3/2018
Start Date:July 2004
End Date:August 2012

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A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed 4-weekly), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Completed Studies CDP870-031 or CDP870-032

An open-label follow-on safety study of CDP870 (400 mg every 4 weeks) in patients with
Crohn's Disease who have completed a 26-week blinded study (CDP870-031 [NCT00152490] or
CDP870-032 [NCT00152425]).


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
We found this trial at
44
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