Status:
COMPLETED
Mucosal Healing Study in Crohn's Disease (CD)
Lead Sponsor:
UCB Pharma
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00297648
Start Date
February 1 2006
End Date
December 1 2009
Last Update
August 31 2011
Active Locations (19)
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1
Bonheiden, Belgium
2
Brussels, Belgium
3
Edegem, Belgium
4
Leuven, Belgium