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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00307931
Date of registration: 24/03/2006
Prospective Registration: Yes
Primary sponsor: UCB Pharma
Public title: Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab
Scientific title: Certolizumab Pegol in the Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Have Been Previously Treated Successfully With Infliximab But Who Have Subsequently Lost Response or Developed Intolerance to Infliximab
Date of first enrolment: April 2007
Target sample size: 16
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT00307931
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Greece
Contacts
Name:     UCB Clinical Trial Call Center
Address: 
Telephone:
Email:
Affiliation:  +1 877 822 9493 (UCB)
Key inclusion & exclusion criteria

Inclusion Criteria:

• Adult men and women with Crohn's disease previously responsive to infliximab who became
non-responsive or intolerant

Exclusion Criteria:

- Symptomatic obstructive intestinal strictures

- Bowel resection within 4 weeks

- Current total parenteral nutrition

- Short bowel syndrome

- Concomitant disease or pathological condition that could interfere with Crohn's
disease or to be harmful for the well being of the patient.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Biological: Certolizumab pegol
Primary Outcome(s)
Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 6 [Time Frame: Baseline, Week 6]
Secondary Outcome(s)
C-reactive Protein Level at Each of Weeks 1, 2, 4, 6, 8, 12 and 14 [Time Frame: Weeks 1, 2, 4, 6, 8, 12 and 14]
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14 [Time Frame: Baseline to Weeks 1, 2, 4, 6, 8, 12 and 14]
Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14 [Time Frame: Weeks 1, 2, 4, 6, 8, 12 and 14]
Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptoms Domain Score at Baseline, and Weeks 6 and 14 [Time Frame: Baseline, and Weeks 6 and 14]
Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score at Baseline, and Weeks 6 and 14 [Time Frame: Baseline, and Weeks 6 and 14]
Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score at Baseline, and Weeks 6 and 14 [Time Frame: Baseline, and Weeks 6 and 14]
Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Symptoms Domain Score at Baseline, and Weeks 6 and 14 [Time Frame: Baseline, and Weeks 6 and 14]
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Baseline, and Weeks 6 and 14 [Time Frame: Baseline, and Weeks 6 and 14]
Number of Patients With a Crohn's Disease Activity Index (CDAI) Score =150 (Remission) at Weeks 1, 6 and 14 or Withdrawal [Time Frame: Weeks 1, 6 and 14 or Withdrawal]
Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, and 14 or Withdrawal [Time Frame: Baseline to Weeks 1, and 14 or Withdrawal]
Number of Patients With at Least a 70-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, 6 and 14 [Time Frame: Baseline to Weeks 1, 6 and 14]
Secondary ID(s)
C87055
Eudract n° - 2006-002027-16
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 19/10/2009
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00307931
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