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

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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
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15 Concord Road
Concord, New South Wales 2137
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Concord,
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Rochester, MN
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Winter Park, FL
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