Open Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study.
18 Years
N/A
Both
Crohn's Disease
Trial Information
Open Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study.
Inclusion Criteria:
- Patients having completed study C87042 [NCT00308581] (previously treated with
infliximab)
Exclusion Criteria:
- Subject withdraw from C87042 [NCT00308581] study
- Subject who received treatment other than certolizumab pegol and other than
medications permitted in C87042 [NCT00308581] study
- Subjects from countries where certolizumab pegol is authorized in Crohn's disease
treatment
- Female patients of childbearing age who are NOT practicing (in the Investigator's
opinion) effective birth control. All female patients must test negative on a serum
pregnancy test before study entry and negative on urine testing immediately before
every certolizumab pegol administration
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)
Outcome Description:
Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.
Outcome Time Frame:
Maximum 164 weeks
Safety Issue:
No
Principal Investigator
UCB Clinical Trial Call Center
Investigator Role:
Study Director
Investigator Affiliation:
+1 877 822 9493 (UCB)
Authority:
Austria: Federal Ministry for Health and Women
Study ID:
C87046
NCT ID:
NCT00333788
Start Date:
October 2006
Completion Date:
April 2010
Related Keywords:
- Crohn's Disease
- Crohn's Disease
- Certolizumab pegol
- CDP870
- Cimzia
- Crohn Disease
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Albany, Georgia 31701 | |
| Miami, Florida 33176 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Louisville, Kentucky 40207 | |
| Omaha, Nebraska 68114 | |
| Metairie, Louisiana 70006 | |
| Charlotte, North Carolina | |
| Eugene, Oregon | |
| Indianapolis, Indiana | |
| Charleston, South Carolina | |
| Tulsa, Oklahoma |
