A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease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

Use our guide to learn which trials are right for you!

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Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease.

A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn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
sites
Colorado Springs, Colorado 80910
1161
mi
from 43215
Colorado Springs, CO
Click here to add this to my saved trials
9467
mi
from 43215
Bankstown,
Click here to add this to my saved trials
428
mi
from 43215
Berlin, NJ
Click here to add this to my saved trials
492
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
278
mi
from 43215
Charlottesville, VA
Click here to add this to my saved trials
323
mi
from 43215
Chevy Chase, MD
Click here to add this to my saved trials
274
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
241
mi
from 43215
Christiansburg, VA
Click here to add this to my saved trials
98
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
64
mi
from 43215
Dayton, OH
Click here to add this to my saved trials
711
mi
from 43215
Gainesville, FL
Click here to add this to my saved trials
501
mi
from 43215
Germantown, TN
Click here to add this to my saved trials
492
mi
from 43215
Great Neck, NY
Click here to add this to my saved trials
Greenville, North Carolina 27834
429
mi
from 43215
Greenville, NC
Click here to add this to my saved trials
337
mi
from 43215
Hershey, PA
Click here to add this to my saved trials
989
mi
from 43215
Hialeah, FL
Click here to add this to my saved trials
322
mi
from 43215
High Point, NC
Click here to add this to my saved trials
991
mi
from 43215
Houston, TX
Click here to add this to my saved trials
410
mi
from 43215
Huntsville, AL
Click here to add this to my saved trials
166
mi
from 43215
Indianapolis, IN
Click here to add this to my saved trials
502
mi
from 43215
Jefferson City, MO
Click here to add this to my saved trials
334
mi
from 43215
Laurel, MD
Click here to add this to my saved trials
154
mi
from 43215
Lexington, KY
Click here to add this to my saved trials
622
mi
from 43215
Little Rock, AR
Click here to add this to my saved trials
135
mi
from 43215
Mayfield Heights, OH
Click here to add this to my saved trials
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
331
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
422
mi
from 43215
Norfolk, VA
Click here to add this to my saved trials
North Miami Beach, Florida 33162
983
mi
from 43215
North Miami Beach, FL
Click here to add this to my saved trials
849
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
1959
mi
from 43215
Orange, CA
Click here to add this to my saved trials
371
mi
from 43215
Raleigh, NC
Click here to add this to my saved trials
559
mi
from 43215
Rochester, MN
Click here to add this to my saved trials
1513
mi
from 43215
Salt Lake City, UT
Click here to add this to my saved trials
1144
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
2107
mi
from 43215
San Francisco, CA
Click here to add this to my saved trials
2005
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
1514
mi
from 43215
South Ogden, UT
Click here to add this to my saved trials
752
mi
from 43215
Tulsa, OK
Click here to add this to my saved trials
306
mi
from 43215
Winston-Salem, NC
Click here to add this to my saved trials