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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00160706 |
A follow-on safety study in patients with Crohn's disease who have previously been withdrawn from study CDP870-031 or CDP870-032 due to an exacerbation of Crohn's disease.
Condition | Intervention | Phase |
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Crohn's Disease |
Biological: CDP870 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Multi-National, Multi-Centre, Open Label, Safety Study to Assess the Safety of re-Exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed at Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease. |
Enrollment: | 310 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Open label administration of CDP870
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Biological: CDP870
CDP870 400mg injection, subcutaneous every 4 weeks, last application: week 204
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Responsible Party: | UCB ( Study Director ) |
Study ID Numbers: | C87034 |
Study First Received: | September 8, 2005 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00160706 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Austria: Federal Ministry for Health and Women; Belarus: Ministry of Health; Belgium: Directorate general for the protection of Public health: Medicines; Bulgaria: Bulgarian Drug Agency; Canada: Health Canada; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Estonia: The State Agency of Medicine; Germany: Paul-Ehrlich-Institut; Hong Kong: Department of Health; Hungary: National Institute of Pharmacy; Ireland: Irish Medicines Board; Israel: Israeli Health Ministry Pharmaceutical Administration; Italy: Ministry of Health; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; New Zealand: Food Safety Authority; Norway: Norwegian Medicines Agency; Poland: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Singapore: Health Sciences Authority; Slovenia: Agency for Medicinal Products - Ministry of Health; South Africa: Medicines Control Council; Spain: Ministry of Health; Ukraine: State Pharmacological Center - Ministry of Health; United States: Food and Drug Administration |
Crohn's disease, CDP870, CDAI, clinical response, remission, Certolizumab Pegol, Cimzia |
Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |