A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease

Completed · Phase 3

Conditions studied: Crohn's Disease

In brief

A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] due to an exacerbation of Crohn's Disease.

Key facts

Study ID

NCT00160706

Run by

UCB Pharma SA

People needed

310

Starts

2004-02-01

Expected to finish

2012-05-01

Last updated by the study team

2018-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• 45028 — Huntsville, Alabama, United States
• 45044 — Little Rock, Arkansas, United States
• 45095 — Orange, California, United States
• 45101 — San Francisco, California, United States
• 45130 — Colorado Springs, Colorado, United States
• 45094 — Gainesville, Florida, United States
• 45005 — Hialeah, Florida, United States
• 45087 — Miami, Florida, United States
• 45004 — North Miami Beach, Florida, United States
• 45016 — Chicago, Illinois, United States
• 45037 — Indianapolis, Indiana, United States
• 45019 — Lexington, Kentucky, United States
• 45033 — Chevy Chase, Maryland, United States
• 45013 — Laurel, Maryland, United States
• 45083 — Rochester, Minnesota, United States
• 45108 — Jefferson City, Missouri, United States
• 45035 — Berlin, New Jersey, United States
• 45009 — Great Neck, New York, United States
• 45070 — New York, New York, United States
• 45145 — Greenville, North Carolina, United States
• 45067 — High Point, North Carolina, United States
• 45003 — Raleigh, North Carolina, United States
• 45040 — Winston-Salem, North Carolina, United States
• 45081 — Cincinnati, Ohio, United States
• 45102 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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