Trial Information
A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.
Inclusion Criteria:
- Patients suffering from active Crohn's disease [Crohn's Disease Activity Index(CDAI)
≥ 220 and ≤ 450] and at least 2 segments with endoscopic ulcerative lesions with
Baseline Crohn's Disease Endoscopic Index of Severity (CDEIS) ≥ 8
- Patients who need to be treated by anti-tumor necrosis factor (anti-TNF) therapy
Exclusion Criteria:
- Obstructive intestinal strictures, bowel resection, proctocolectomy or total
colectomy, current total parenteral nutrition, short bowel syndrome
- History of tuberculosis or positive tests for tuberculosis at screening
- All the concomitant diseases or pathological conditions that could interfere with
Crohn's disease assessment or to be harmful for the well being of the patient
- Previous clinical trials and previous biological therapy that could interfere with
the results in the present clinical trial
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments
Outcome Description:
The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.
Outcome Time Frame:
Baseline, Week 10
Safety Issue:
No
Principal Investigator
UCB Clinical Trial Call Center
Investigator Role:
Study Director
Investigator Affiliation:
+1 877 822 9493 (UCB)
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
C87043
NCT ID:
NCT00297648
Start Date:
February 2006
Completion Date:
December 2009
Related Keywords:
- Crohn's Disease
- Certolizumab pegol
- Crohn's disease
- Mucosal healing
- Crohn Disease