A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:8/9/2018
Start Date:February 2004
End Date:May 2012

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A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Re-exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed at Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease.

A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn
from the double-blind study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] due to an
exacerbation of Crohn's Disease.


Inclusion Criteria:

- Participation in either of the CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]
clinical studies in which the subject completed the Week 2 assessment in CDP870-031
[NCT00152490] or the Week 6 randomization in CDP870-032 [NCT00152425] but whose
Crohn's Disease was significantly worse as determined by the investigator and whose
Clinical Disease Activity Index (CDAI) score at entry to this study is either
(subjects may have received active or placebo treatment):

1. At least 70 points higher then Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6
CDP870 032 [NCT00152425] responders) OR

2. Higher than Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6 CDP870-032
[NCT00152425] responders) with an absolute score of at least 350 points

- 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 upper limit of 450 in the CDAI score is not applicable. In addition the
criterion that excludes previous participation in a clinical trial of Certolizumab
Pegol does not apply
We found this trial at
41
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Greenville, North Carolina 27834
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Huntsville, AL
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Indianapolis, IN
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North Miami Beach, Florida 33162
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156
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