A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:8/11/2018
Start Date:May 2008
End Date:December 2014

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

A Phase IIIb, Multinational, Open-label, follow-on Trial to C87085 Designed to Assess the Long-term Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-TNF-alpha Monoclonal Antibody, Administered at Weeks 0, 2 and 4, and Then Every 4 Weeks Thereafter, in Subjects With Moderately to Severely Active Crohn's Disease Who Have Participated in Study C87085

The primary objective of the study is to assess the safety of long term therapy with
Certolizumab Pegol in those subjects participating in study C87085 [NCT00552058].

This study consisted of:

- Induction Period (dosing at Weeks 0, 2, and 4)

- Maintenance Dosing (dosing every 4 weeks up to Week 260)

- End of Treatment Visit that occurred at Week 262/Withdrawal Visit and a Safety Follow-up
Visit (SFU; 12 weeks after final dose)

Inclusion Criteria:

- Subject participated in study C87085 [NCT00552058] in which the subject completed the
study at Week 6

- Subject is capable of providing informed consent, which must be obtained prior to any
study related procedures

- Have a chest X-ray taken at Visit 1 that is read by a qualified radiologist or
pulmonary physician, with no evidence of current active Tuberculosis (TB) or old
inactive TB

- Subject has taken a TB survey and is committed to comply with TB prophylaxis if
applicable

Exclusion Criteria:

- Subject is experiencing an ongoing serious adverse event assessed as being related to
study medication or is experiencing a serious adverse event that is still not
assessable

- Subject has an intercurrent illness that requires termination of treatment, such as a
serious infection (e.g. TB, pneumonia, sepsis, pyelonephritis, fistula abscess)

- Subject is non-compliant with TB prophylactic treatment (if applicable)

- Subject has had a chest X-ray at Visit 1 that shows an abnormality suggestive of a
malignancy or active infection, including TB

- Female who is pregnant or breast feeding

- Female of child bearing age or post puberty males not practicing effective birth
control

- Subject is expecting to receive any live virus or bacterial vaccination within 3
months of first Study Medication administration, during the trial or 3 months after
last dose of study drug
We found this trial at
20
sites
354
mi
from 43215
Annapolis, MD
Click here to add this to my saved trials
186
mi
from 43215
Chesterfield, MI
Click here to add this to my saved trials
274
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
98
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
127
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
15 Concord Road
Concord, New South Wales 2137
9462
mi
from 43215
Concord,
Click here to add this to my saved trials
501
mi
from 43215
Germantown, TN
Click here to add this to my saved trials
1167
mi
from 43215
Lakewood, CO
Click here to add this to my saved trials
353
mi
from 43215
Lancaster, PA
Click here to add this to my saved trials
1164
mi
from 43215
Littleton, CO
Click here to add this to my saved trials
188
mi
from 43215
Louisville, KY
Click here to add this to my saved trials
797
mi
from 43215
Metairie, LA
Click here to add this to my saved trials
721
mi
from 43215
Monroe, LA
Click here to add this to my saved trials
810
mi
from 43215
New Port Richey, FL
Click here to add this to my saved trials
422
mi
from 43215
Norfolk, VA
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
2005
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
342
mi
from 43215
Towson, MD
Click here to add this to my saved trials
791
mi
from 43215
Winter Park, FL
Click here to add this to my saved trials