Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab

This study has been terminated.
(Study was terminated early because of slow recruitment)
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00307931
First received: March 24, 2006
Last updated: August 30, 2011
Last verified: December 2009
Results First Received: September 8, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Crohn's Disease
Intervention: Biological: Certolizumab pegol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study screened 17 subjects in 7 sites in Greece. The first subject was screened in March 2007 and the last subject was screened in February 2008. Of the 17 subjects screened, 16 were included in the Intention-to-treat population, i.e., were enrolled in the study and received at least one dose of study medication.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Certolizumab Pegol 400 mg Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12

Participant Flow:   Overall Study
    Certolizumab Pegol 400 mg  
STARTED     16 [1]
COMPLETED     15 [2]
NOT COMPLETED     1  
Adverse Event                 1  
[1] Number of subjects who entered the study and have been treated
[2] Number of subjects who completed the Week 12 visit



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Certolizumab Pegol 400 mg Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12

Baseline Measures
    Certolizumab Pegol 400 mg  
Number of Participants  
[units: participants]
  16  
Age  
[units: years]
Mean ± Standard Deviation
  42.45  ± 15.40  
Gender  
[units: participants]
 
Female     9  
Male     7  
Region of Enrollment  
[units: participants]
 
Greece     16  
Body Height  
[units: cm]
Mean ± Standard Deviation
  168.7  ± 9.2  
Body Mass Index  
[units: kg/m^2]
Mean ± Standard Deviation
  22.20  ± 4.98  
Body Weight  
[units: kg]
Mean ± Standard Deviation
  64.0  ± 19.5  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Baseline, and Weeks 6 and 14   [ Time Frame: Baseline, and Weeks 6 and 14 ]

9.  Secondary:   Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptoms Domain Score at Baseline, and Weeks 6 and 14   [ Time Frame: Baseline, and Weeks 6 and 14 ]

10.  Secondary:   Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Symptoms Domain Score at Baseline, and Weeks 6 and 14   [ Time Frame: Baseline, and Weeks 6 and 14 ]

11.  Secondary:   Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score at Baseline, and Weeks 6 and 14   [ Time Frame: Baseline, and Weeks 6 and 14 ]

12.  Secondary:   Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score at Baseline, and Weeks 6 and 14   [ Time Frame: Baseline, and Weeks 6 and 14 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was terminated early due to slow recruitment, namely only 17 subjects were recruited although the sample size had planned for approximately 50 subjects. As a consequence, the majority of secondary outcome measures were not summarized.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
phone: +1 877 822 9493


No publications provided


Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00307931     History of Changes
Other Study ID Numbers: C87055, Eudract n° - 2006-002027-16
Study First Received: March 24, 2006
Results First Received: September 8, 2009
Last Updated: August 30, 2011
Health Authority: Greece: National Organization of Medicines