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A 26-week, Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed Clinical Efficacy in a Remission Induction Study (Study C87037 [NCT00291668]), at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week Intervals
This is a multi-centre, open-label extension study in subjects who showed clinical response to induction therapy in the treatment of subjects with active Crohn's disease in the double-blind main study C87037 (NCT00291668).
In the double-blind main study subjects were dosed at Weeks 0, 2 and 4, with the primary outcome, clinical response, being assessed at Week 6. Subjects who showed clinical response at Week 6 were eligible to enter this open-label extension study. The first visit in this extension study was 2 weeks after Week 6, i.e., Week 8. Subjects in this extension study were dosed at Weeks 8, 12, 16, 20 and 24, with the primary outcome, clinical response, being assessed at Week 26. All week numbers quoted are relative to the start of the double-blind main study.
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
April 1, 2008
Completion Date
April 1, 2008
Last Updated
March 18, 2015
40
ACTUAL participants
Certolizumab pegol (CZP)
BIOLOGICAL
Certolizumab pegol (CZP)
BIOLOGICAL
Certolizumab pegol (CZP)
BIOLOGICAL
Lead Sponsor
UCB Japan Co. Ltd.
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