This is an open-label extension study designed to measure the safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol (CDP870) in patients with moderate to severe Crohn's disease previously enrolled in C87059 (COSPAR I, NCT00349752).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
Certolizumab pegol (CDP870), an anti-tumor necrosis factor (TNF)α, humanized antibody Fab' fragment - polyethylene glycol conjugate, solution for injection, in 10 mM sodium acetate buffer and 125 mM sodium chloride, pH 4.7, supplied in 3 mL vials with a fill of 1.4 mL (an extractable volume of 1 mL corresponds to a dose of 200 mg). Dosing is every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2.
Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)
Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.
Time frame: During this study (maximum 122 weeks)
Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids.
Crohn's disease activity index (CDAI) is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in disease remission at Week 34.
Time frame: Week 34 in this study
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Birmingham, Alabama, United States
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Montgomery, Alabama, United States
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La Jolla, California, United States
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Oceanside, California, United States
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Palo Alto, California, United States
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Roseville, California, United States
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Lakewood, Colorado, United States
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Clearwater, Florida, United States
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Gainesville, Florida, United States
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Hialeah, Florida, United States
...and 53 more locations