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

Completed · Phase 3

Conditions studied: Crohn Disease

In brief

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 \[NCT00552058\].

Key facts

Study ID

NCT00552344

Run by

UCB BIOSCIENCES GmbH

People needed

403

Starts

2008-05-01

Expected to finish

2014-12-01

Last updated by the study team

2018-08-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 285 — Littleton, Colorado, United States
• 278 — New Port Richey, Florida, United States
• 300 — Winter Park, Florida, United States
• 276 — Chicago, Illinois, United States
• 279 — Louisville, Kentucky, United States
• 275 — Metairie, Louisiana, United States
• 307 — Monroe, Louisiana, United States
• 281 — Annapolis, Maryland, United States
• 295 — Towson, Maryland, United States
• 310 — Chesterfield, Michigan, United States
• 298 — Rochester, Minnesota, United States
• 272 — Raleigh, North Carolina, United States
• 296 — Cincinnati, Ohio, United States
• 289 — Cleveland, Ohio, United States
• 280 — Lancaster, Pennsylvania, United States
• 305 — Germantown, Tennessee, United States
• 306 — Germantown, Tennessee, United States
• 308 — Norfolk, Virginia, United States
• 290 — Seattle, Washington, United States
• 15 — Concord, New South Wales, Australia
• 20 — Box Hill, Victoria, Australia
• 12 — Footscray, Victoria, Australia
• 16 — Parkville, Victoria, Australia
• 14 — Bankstown, Australia
• 284 — Lakewood, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.