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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: 12 December 2020
Main ID:  NCT00308581
Date of registration: 28/03/2006
Prospective Registration: Yes
Primary sponsor: UCB Pharma
Public title: Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab
Scientific title: Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab
Date of first enrolment: April 2006
Target sample size: 539
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00308581
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 3
Countries of recruitment
Austria Belgium Canada Denmark France Germany Italy Netherlands
Norway Spain Sweden Switzerland United Kingdom United States
Contacts
Name:     UCB Clinical Trial Call Center
Address: 
Telephone:
Email:
Affiliation:  +1 877 822 9493 (UCB)
Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects with Crohn's Disease

- Previous treatment failure to Infliximab (intolerance and/or no response)

Exclusion Criteria:

- 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



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
Other: Placebo
Primary Outcome(s)
Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase [Time Frame: Baseline to Week 6]
Secondary Outcome(s)
C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase [Time Frame: Week 0]
CDAI Score at Week 10 in the Randomized Maintenance Phase [Time Frame: Week 10]
CDAI Score at Week 12 in the Randomized Maintenance Phase [Time Frame: Week 12]
CDAI Score at Week 14 in the Randomized Maintenance Phase [Time Frame: Week 14]
CDAI Score at Week 16 in the Randomized Maintenance Phase [Time Frame: Week 16]
CDAI Score at Week 18 in the Randomized Maintenance Phase [Time Frame: Week 18]
CDAI Score at Week 2 of the Induction Phase [Time Frame: Week 2]
CDAI Score at Week 20 in the Randomized Maintenance Phase [Time Frame: Week 20]
CDAI Score at Week 22 in the Randomized Maintenance Phase [Time Frame: Week 22]
CDAI Score at Week 24 in the Randomized Maintenance Phase [Time Frame: Week 24]
CDAI Score at Week 26 in the Randomized Maintenance Phase [Time Frame: Week 26]
CDAI Score at Week 4 of the Induction Phase [Time Frame: Week 4]
CDAI Score at Week 6 of the Induction Phase [Time Frame: Week 6]
CDAI Score at Week 8 in the Randomized Maintenance Phase [Time Frame: Week 8]
Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase [Time Frame: Baseline to Week 10]
Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase [Time Frame: Baseline to Week 12]
Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase [Time Frame: Baseline to Week 14]
Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase [Time Frame: Baseline to Week 16]
Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase [Time Frame: Baseline to Week 18]
Change From Baseline in CDAI Score at Week 2 of the Induction Phase [Time Frame: Baseline to Week 2]
Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase [Time Frame: Baseline to Week 20]
Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase [Time Frame: Baseline to Week 22]
Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase [Time Frame: Baseline to Week 24]
Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase [Time Frame: Baseline to Week 26]
Change From Baseline in CDAI Score at Week 4 of the Induction Phase [Time Frame: Baseline to Week 4]
Change From Baseline in CDAI Score at Week 6 of the Induction Phase [Time Frame: Baseline to Week 6]
Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase [Time Frame: Baseline to Week 8]
CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase [Time Frame: Last visit on or before Week 26]
CRP Level at Week 10 in the Randomized Maintenance Phase [Time Frame: Week 10 (optional measurement)]
CRP Level at Week 12 in the Randomized Maintenance Phase [Time Frame: Week 12]
CRP Level at Week 14 in the Randomized Maintenance Phase [Time Frame: Week 14 (optional measurement)]
CRP Level at Week 16 in the Randomized Maintenance Phase [Time Frame: Week 16]
CRP Level at Week 18 in the Randomized Maintenance Phase [Time Frame: Week 18 (optional measurement)]
CRP Level at Week 2 of the Induction Phase [Time Frame: Week 2]
CRP Level at Week 20 in the Randomized Maintenance Phase [Time Frame: Week 20]
CRP Level at Week 22 in the Randomized Maintenance Phase [Time Frame: Week 22 (optional measurement)]
CRP Level at Week 24 in the Randomized Maintenance Phase [Time Frame: Week 24]
CRP Level at Week 26 in the Randomized Maintenance Phase [Time Frame: Week 26]
CRP Level at Week 4 of the Induction Phase [Time Frame: Week 4]
CRP Level at Week 6 of the Induction Phase [Time Frame: Week 6]
CRP Level at Week 8 in the Randomized Maintenance Phase [Time Frame: Week 8]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 10]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 12]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 14]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 16]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 18]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 20]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 22]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 24]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 26]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 10]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 12]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 14]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 16]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 18]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 20]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 22]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 24]
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [Time Frame: Week 26]
Remission Status With Remission Defined as CDAI Score = 150 in the Induction Phase [Time Frame: Week 6]
Remission Status With Remission Defined as CDAI Score = 150 in the Randomized Maintenance Phase [Time Frame: Week 26]
Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase [Time Frame: Baseline to Week 26]
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase [Time Frame: Baseline to Week 6]
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase [Time Frame: Baseline to Week 26]
Secondary ID(s)
C87042
Eudract number: 2005-004104-37
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 17/11/2009
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00308581
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