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Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease (COSPAR II)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00356408
First Posted: July 26, 2006
Last Update Posted: September 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
Results First Submitted: February 23, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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
The study was started in January 2007 with recruitment occurring in the United States, Germany, and Canada. The study had last patient last visit in February of 2010.

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
CDP870 400 mg Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn’s disease indication in the patient’s country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2

Participant Flow:   Overall Study
    CDP870 400 mg
STARTED   103 [1] 
COMPLETED   43 
NOT COMPLETED   60 
Adverse Event                9 
Lack of Efficacy                36 
Lost to Follow-up                2 
Withdrawal by Subject                6 
Other: Principal investigator discretion                3 
Other: Sponsor request                1 
Other: Azathioprine stopped                1 
Other: Failed to meet Inc/Exc criteria                1 
Other: Subject chose commerical dosing                1 
[1] 106 subjects enrolled, however only 103 were included in the Intent to Treat (ITT) population.



  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
Placebo/Completer Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
CDP870/Completer CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
Placebo/Non-completer Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
CDP870/Non-completer CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
Total Total of all reporting groups

Baseline Measures
   Placebo/Completer   CDP870/Completer   Placebo/Non-completer   CDP870/Non-completer   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   16   40   33   103 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   14   16   39   32   101 
>=65 years   0   0   1   1   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.00  (12.53)   39.31  (12.83)   38.44  (13.73)   41.38  (13.75)   40.27  (13.39) 
Gender 
[Units: Participants]
         
Female   6   9   22   18   55 
Male   8   7   18   15   48 
Region of Enrollment 
[Units: Participants]
         
United States   8   10   31   21   70 
Canada   4   6   7   10   27 
Germany   2   0   2   2   6 


  Outcome Measures
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1.  Primary:   Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)   [ Time Frame: During this study (maximum 122 weeks) ]

2.  Secondary:   Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids.   [ Time Frame: Week 34 in this study ]


  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
No text entered.


  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 (Study Director)
Organization: UCB Clinical Trial Call Center
phone: +1 887 822 9493



Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00356408     History of Changes
Other Study ID Numbers: C87065
2006-003871-11 ( EudraCT Number )
First Submitted: July 25, 2006
First Posted: July 26, 2006
Results First Submitted: February 23, 2011
Results First Posted: May 25, 2011
Last Update Posted: September 5, 2014