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A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease

This study has been completed.
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT00552344
First received: October 31, 2007
Last updated: January 29, 2016
Last verified: January 2016
Results First Received: December 14, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Crohn Disease
Intervention: Biological: Cimzia

  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 started to enroll patients in May 2008 and concluded in Dec 2014. Participant Flow refers to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
406 subjects were screened: 3 subjects were considered as screen failures and were not enrolled. 403 subjects entered the study from C87085. 1 subject was enrolled in this study, but did not receive any open-label study medication and was withdrawn from the study; this subject was, therefore, not included in any of the analyses.

Reporting Groups
  Description
Certolizumab Pegol Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.

Participant Flow:   Overall Study
    Certolizumab Pegol  
STARTED     402  
COMPLETED     87  
NOT COMPLETED     315  
Lack of Efficacy                 55  
Loss of efficacy                 75  
Lost to Follow-up                 8  
Withdrawal by Subject                 48  
SAE, non-fatal                 6  
AE, non-serious non-fatal                 38  
SAE,non-fatal+AE,non-serious non-fatal                 62  
SAE, fatal + AE, non-serious non-fatal                 1  
Other Reason                 22  



  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.
Baseline Characteristics refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication. Demographics presented below were collected at Screening of the feeder study C87085.

Reporting Groups
  Description
Certolizumab Pegol Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
Total Title No text entered.

Baseline Measures
    Certolizumab Pegol     Total Title  
Number of Participants  
[units: participants]
  402     402  
Age, Customized  
[units: Participants]
   
18 - < 65 years     393      
65 - < 85 years     9      
>= 85 years     0      
Age  
[units: years]
Mean (Standard Deviation)
  37.3  (12.68)      
Gender  
[units: Participants]
   
Female     221      
Male     181      



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks)   [ Time Frame: From study start to the end of the Safety Follow-up Period (up to 272 weeks) ]

2.  Primary:   Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 Weeks)   [ Time Frame: From study start to the end of the Safety Follow-up Period (up to 272 weeks) ]

3.  Secondary:   Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262)   [ Time Frame: Week 262 ]

4.  Secondary:   Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262)   [ Time Frame: Week 262 ]

5.  Secondary:   Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52)   [ Time Frame: Week 52 ]

6.  Secondary:   Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study C87085 to the Study Completion Visit in C87088   [ Time Frame: From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks) ]


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: UCB (Study Director)
Organization: UCB Cares
phone: +1 887 822 9493



Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT00552344     History of Changes
Other Study ID Numbers: C87088
2007-002716-26 ( EudraCT Number )
Study First Received: October 31, 2007
Results First Received: December 14, 2015
Last Updated: January 29, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: Ministry of Social Affairs, Public Health and the Environment
Brazil: Ministry of Health
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: National Institute of Health
Latvia: State Agency of Medicines
New Zealand: Health Research Council
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
United States: Food and Drug Administration
Ukraine: Ministry of Health