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A Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed no Clinical Efficacy in a Remission Induction Study (Study C87037) But Showed Clinical Efficacy After Additional Remission Induction Therapy Was Applied, at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week Intervals
This 26-week extension study evaluates the efficacy and safety of certolizumab pegol administered subcutaneously every 4 weeks (dosed at Weeks 16, 20, 24, 28 and 32) in subjects with active Crohn's disease who had no clinical response at Week 6 to induction therapy in the 6-week double-blind main study, C87037 (NCT00291668), but subsequently showed clinical response at Week 14 to repeated induction therapy (dosed at Weeks 8, 10 and 12) in this extension study.
This study is an open-label extension study which follows on from the 6-week double-blind main study C87037 (NCT00291668). All 'Week' numbers quoted are relative to the start of the double-blind main study. The first visit in this extension study is at Week 8, and the final efficacy assessment in this extension study, 26 weeks later, is at Week 34.
Age
16 - 64 years
Sex
ALL
Healthy Volunteers
No
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
Fukuoka, Fukuoka, Japan
Asahikawa, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Start Date
May 1, 2006
Primary Completion Date
May 1, 2008
Completion Date
May 1, 2008
Last Updated
March 18, 2015
46
ACTUAL participants
Certolizumab pegol
BIOLOGICAL
Certolizumab pegol
BIOLOGICAL
Certolizumab pegol
BIOLOGICAL
Lead Sponsor
UCB Pharma
NCT06226883
NCT07184931
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06918808