Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease
NCT ID: NCT00291668
Last Updated: 2020-08-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
94 participants
INTERVENTIONAL
2006-03-02
2007-11-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Certolizumab pegol 200 mg
Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.
Certolizumab Pegol
* Active Substance: Certolizumab Pegol
* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 200 mg/mL
* Route of Administration: Subcutaneous use
Placebo
* Active Substance: isotonic sodium chloride solution
* Pharmaceutical Form: Solution for injection
* Concentration: 1 mL
* Route of Administration: Subcutaneous use
Certolizumab pegol 400 mg
Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
Certolizumab Pegol
* Active Substance: Certolizumab Pegol
* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 200 mg/mL
* Route of Administration: Subcutaneous use
Placebo
Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.
Placebo
* Active Substance: isotonic sodium chloride solution
* Pharmaceutical Form: Solution for injection
* Concentration: 1 mL
* Route of Administration: Subcutaneous use
Interventions
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Certolizumab Pegol
* Active Substance: Certolizumab Pegol
* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 200 mg/mL
* Route of Administration: Subcutaneous use
Placebo
* Active Substance: isotonic sodium chloride solution
* Pharmaceutical Form: Solution for injection
* Concentration: 1 mL
* Route of Administration: Subcutaneous use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with Crohn's Disease Activity Index (CDAI) score ranging from 220 to 450 inclusive during the observation period
* C-reactive protein (CRP) of 1 mg/dL or higher in the laboratory test performed at the start of the observation period
Exclusion Criteria
* Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF alpha antibody
* Patients who participated in a clinical study with CDP870
* Pregnant or lactating patients, patients of childbearing potential, or patients who will attempt pregnancy during the study period
* Patients who are judged inappropriate for enrollment by the principal investigator or subinvestigators
16 Years
65 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Locations
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Aichi-Gun, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Toyoake, Aichi-ken, Japan
Toyohashi, Aichi-ken, Japan
Kashiwa, Chiba, Japan
Sakura, Chiba, Japan
Chikusino, Fukuoka, Japan
Asahikawa, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Nishinomiya, Hyōgo, Japan
Yokohama, Kanagawa, Japan
Miyazaki-gun, Miyazaki, Japan
Kurashiki, Okayama-ken, Japan
Tyuto-gun, Okinawa, Japan
Suita, Osaka, Japan
Ōtsu, Shiga, Japan
Shinjyuku, Tokyo, Japan
Fukuoka, , Japan
Kagoshima, , Japan
Nagasaki, , Japan
Niigata, , Japan
Osaka, , Japan
Countries
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Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2014-004399-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C87037
Identifier Type: -
Identifier Source: org_study_id
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