Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.
18 Years
75 Years
Both
Crohn Disease
Trial Information
Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.
Inclusion Criteria:
- male/female
- 18 - 75 years inclusive
- diagnosis of Crohn's disease confirmed
- moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)
- no previous treatment with anti-tumor necrosis factor (anti-TNF) medications
Exclusion Criteria:
- previous participation in a certolizumab pegol study
- general exclusion criteria as common for studies in this indication
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Percentage of Subjects in Clinical Remission at Week 6
Outcome Description:
The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Outcome Time Frame:
Week 6
Safety Issue:
No
Principal Investigator
UCB Clinical Trial Call Center
Investigator Role:
Study Director
Investigator Affiliation:
+1 877 822 9493 (UCB)
Authority:
United States: Food and Drug Administration
Study ID:
C87085
NCT ID:
NCT00552058
Start Date:
March 2008
Completion Date:
November 2009
Related Keywords:
- Crohn Disease
- CDP 870
- Certolizumab Pegol
- CIMZIA ®
- Crohn's disease
- Induction
- Clinical remission
- Clinical response
- Crohn Disease
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Alexandria, Minnesota 56308 | |
| Birmingham, Alabama 35294 | |
| Miami, Florida 33176 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Seattle, Washington 98195 | |
| Flint, Michigan 48532 | |
| Louisville, Kentucky 40207 | |
| McLean, Virginia 22101 | |
| Metairie, Louisiana 70006 | |
| Denver, Colorado | |
| Baltimore, Maryland 21287 | |
| Charlotte, North Carolina |
