Status:
COMPLETED
Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab
Lead Sponsor:
UCB Pharma
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab
Eligibility Criteria
Inclusion
- Subjects with Crohn's Disease
- Previous treatment failure to Infliximab (intolerance and/or no response)
Exclusion
- Obstructive intestinal strictures
- Recent bowel resection
- Proctocolectomy or total colectomy
- Current total parenteral nutrition
- Short bowel syndrome
- All 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 :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
539 Patients enrolled
Trial Details
Trial ID
NCT00308581
Start Date
April 1 2006
End Date
April 1 2008
Last Update
August 7 2018
Active Locations (107)
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1
San Francisco, California, United States
2
Gainesville, Florida, United States
3
Atlanta, Georgia, United States
4
Chicago, Illinois, United States