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Trial record 1 of 1 for:    NCT00307931
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Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab

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ClinicalTrials.gov Identifier: NCT00307931
Recruitment Status : Terminated (Study was terminated early because of slow recruitment)
First Posted : March 28, 2006
Results First Posted : October 19, 2009
Last Update Posted : August 31, 2011
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Crohn's Disease
Intervention Biological: Certolizumab pegol
Enrollment 16
Recruitment Details 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  
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Period Title: Overall Study
Started 16 [1]
Completed 15 [2]
Not Completed 1
Reason Not Completed
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
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
42.45  (15.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
9
  56.3%
Male
7
  43.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Greece Number Analyzed 16 participants
16
Body Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 16 participants
168.7  (9.2)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 16 participants
22.20  (4.98)
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 16 participants
64.0  (19.5)
1.Primary Outcome
Title Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 6
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
7
2.Secondary Outcome
Title 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
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Weeks 1, and 14 or Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
Week 1 6
Week 14 or Withdrawal 6
3.Secondary Outcome
Title 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
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Weeks 1, 6 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Patients With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Weeks 1, 6 and 14 or Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
Week 1 3
Week 6 5
Week 14 or Withdrawal 3
5.Secondary Outcome
Title Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Weeks 1, 2, 4, 6, 8, 12 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14
Hide Description The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Baseline to Weeks 1, 2, 4, 6, 8, 12 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title C-reactive Protein Level at Each of Weeks 1, 2, 4, 6, 8, 12 and 14
Hide Description [Not Specified]
Time Frame Weeks 1, 2, 4, 6, 8, 12 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Baseline, and Weeks 6 and 14
Hide Description The IBDQ Total Score is the sum of 32 responses, each ranging from 0 to 7, thus the Total Score ranges from 0 to 224; a higher score indicating a better quality of life.
Time Frame Baseline, and Weeks 6 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptoms Domain Score at Baseline, and Weeks 6 and 14
Hide Description The IBDQ Bowel Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Baseline, and Weeks 6 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Symptoms Domain Score at Baseline, and Weeks 6 and 14
Hide Description The IBDQ Systemic Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Baseline, and Weeks 6 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score at Baseline, and Weeks 6 and 14
Hide Description The IBDQ Emotional Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Baseline, and Weeks 6 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score at Baseline, and Weeks 6 and 14
Hide Description The IBDQ Social Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Baseline, and Weeks 6 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data were collected during the treatment period and safety follow-up period, namely until 12 weeks following the last dose of study medication for each subject (which could be a time frame up to 24 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
All-Cause Mortality
Certolizumab Pegol 400 mg
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Certolizumab Pegol 400 mg
Affected / at Risk (%) # Events
Total   3/16 (18.75%)    
Gastrointestinal disorders   
Diarrhoea * 1  2/16 (12.50%)  2
Abdominal pain * 1  1/16 (6.25%)  1
General disorders   
Pyrexia * 1  2/16 (12.50%)  2
Infections and infestations   
Streptococcal sepsis * 1  1/16 (6.25%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Certolizumab Pegol 400 mg
Affected / at Risk (%) # Events
Total   4/16 (25.00%)    
Gastrointestinal disorders   
Crohn's disease * 1  2/16 (12.50%)  2
Infections and infestations   
Perianal abscess * 1  1/16 (6.25%)  1
Investigations   
C-reactive protein increased * 1  2/16 (12.50%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
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.
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.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00307931    
Other Study ID Numbers: C87055
Eudract n° - 2006-002027-16
First Submitted: March 24, 2006
First Posted: March 28, 2006
Results First Submitted: September 8, 2009
Results First Posted: October 19, 2009
Last Update Posted: August 31, 2011