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 |
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]).
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
sites
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