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Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease (Welcome2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00333788
First received: June 2, 2006
Last updated: August 30, 2011
Last verified: August 2011
History of Changes
Results First Received: April 13, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Crohn's Disease
Intervention: Biological: Certolizumab pegol (CDP870)

  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 started in October 2006, with recruitment in the United States, Austria, Belgium, Canada, France, Germany, Italy, Spain, Sweden, Switzerland, the United Kingdom and the Netherlands. This study completed in April 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The summary of Participant Flow is based on the All Subjects Population.

Reporting Groups
  Description
Certolizumab Pegol 400 mg 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks

Participant Flow:   Overall Study
    Certolizumab Pegol 400 mg  
STARTED     233 [1]
COMPLETED     71  
NOT COMPLETED     162  
Adverse Event                 44  
Lack of Efficacy                 80  
Lost to Follow-up                 2  
Withdrawal by Subject                 24  
Other: Non-compliance                 2  
Other: Moved                 2  
Other: Recurrent squamaous cell cancer                 1  
Other: Investigator decision                 1  
Other: Quality of life concern                 1  
Other: Sponsor decision                 1  
Other: Subject in need of an Entocort                 1  
Other: Medical monitor decision                 1  
Other: Physician decision                 1  
Other: Signed consent for another study                 1  
[1] Participant flow based on All Subjects population; Baseline characteristics based on ITT population.



  Baseline Characteristics
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Reporting Groups
  Description
Certolizumab Pegol 400 mg 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks

Baseline Measures
    Certolizumab Pegol 400 mg  
Number of Participants  
[units: participants]
 		  229  
Age [1]
[units: participants]
 		 
<=18 years     1  
Between 18 and 65 years     224  
>=65 years     4  
Age [1]
[units: years]
Mean ± Standard Deviation 		  31.8  ± 11.6  
Gender [1]
[units: participants]
 		 
Female     146  
Male     83  
Region of Enrollment [1]
[units: participants]
 		 
France     20  
United States     70  
Canada     20  
Spain     6  
Belgium     30  
Austria     8  
Netherlands     2  
Germany     34  
United Kingdom     9  
Switzerland     4  
Italy     24  
Sweden     2  
[1] Baseline characteristics are based on the ITT population; Participant flow is based on the All Subjects population.



  Outcome Measures
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1.  Primary:   Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)   [ Time Frame: Maximum 164 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042).   [ Time Frame: Baseline (corresponding to Week 26 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals] ]
  Show Outcome Measure 2

3.  Secondary:   Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]   [ Time Frame: Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals] ]
  Show Outcome Measure 3

4.  Secondary:   Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]   [ Time Frame: Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals] ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline of Study C87042 (NCT00308581) in Crohn’s Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]   [ Time Frame: Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals] ]
  Show Outcome Measure 5

6.  Secondary:   Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study   [ Time Frame: Maximum 154 weeks ]
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7.  Secondary:   Occurrence of at Least 1 Hospital Stay During the Treatment Period   [ Time Frame: Maximum 152 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Occurrence of at Least 1 Hospital Stay During the Follow-Up Period   [ Time Frame: Maximum 12 weeks ]
  Hide Outcome Measure 8

Measure Type Secondary
Measure Title Occurrence of at Least 1 Hospital Stay During the Follow-Up Period
Measure Description

Follow-up period starts the day after the last injection up to 84 days after last injection.

Results are presented as the percentage of subjects with at least 1 hospital stay during the follow-up period.
Time Frame Maximum 12 weeks  
Safety Issue No  

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.
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.

Reporting Groups
  Description
Certolizumab Pegol 400 mg 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks

Measured Values
    Certolizumab Pegol 400 mg  
Number of Participants Analyzed  
[units: participants]
 		  229  
Occurrence of at Least 1 Hospital Stay During the Follow-Up Period  
[units: percentage of participants]
 		  21.8  

No statistical analysis provided for Occurrence of at Least 1 Hospital Stay During the Follow-Up Period



9.  Secondary:   Occurrence of at Least 1 Hospital Stay During the During the Overall Period   [ Time Frame: Maximum 164 weeks ]
  Show Outcome Measure 9

10.  Secondary:   Length of Hospital Stays During the Treatment Period   [ Time Frame: Maximum 152 weeks ]
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11.  Secondary:   Length of Hospital Stays During the Follow-Up Period   [ Time Frame: Maximum 12 weeks ]
  Show Outcome Measure 11

12.  Secondary:   Length of Hospital Stays During the Overall Period   [ Time Frame: Maximum 164 weeks ]
  Show Outcome Measure 12

13.  Secondary:   Occurrence of at Least 1 Emergency Room Visit During the Treatment Period   [ Time Frame: Maximum 152 weeks ]
  Show Outcome Measure 13

14.  Secondary:   Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period   [ Time Frame: Maximum 12 weeks ]
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15.  Secondary:   Occurrence of at Least 1 Emergency Room Visit During the Overall Period   [ Time Frame: Maximum 164 weeks ]
  Show Outcome Measure 15

16.  Secondary:   Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn’s Disease During the Treatment Period   [ Time Frame: Maximum 152 weeks ]
  Show Outcome Measure 16

17.  Secondary:   Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn’s Disease During the Follow-Up Period   [ Time Frame: Maximum 12 weeks ]
  Show Outcome Measure 17

18.  Secondary:   Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn’s Disease During the Overall Period   [ Time Frame: Maximum 164 weeks ]
  Show Outcome Measure 18

19.  Secondary:   Occurrence of at Least 1 General Concomitant Medication During the Treatment Period   [ Time Frame: Maximum 152 weeks ]
  Show Outcome Measure 19

20.  Secondary:   Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period   [ Time Frame: Maximum 12 weeks ]
  Show Outcome Measure 20

21.  Secondary:   Occurrence of at Least 1 General Concomitant Medication During the Overall Period   [ Time Frame: Maximum 164 weeks ]
  Show Outcome Measure 21

22.  Secondary:   Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period.   [ Time Frame: Maximum 152 weeks ]
  Show Outcome Measure 22

23.  Secondary:   Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period   [ Time Frame: Maximum 12 weeks ]
  Show Outcome Measure 23

24.  Secondary:   Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period   [ Time Frame: Maximum 164 weeks ]
  Show Outcome Measure 24


  Serious Adverse Events
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  Other Adverse Events
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  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.


Limitations and Caveats
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.  


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


No publications provided


Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00333788     History of Changes
Other Study ID Numbers: C87046, 2006-001729-24
Study First Received: June 2, 2006
Results First Received: April 13, 2011
Last Updated: August 30, 2011
Health Authority: Austria: Federal Ministry for Health and Women
Belgium: Directorate general for the protection of Public health: Medicines
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Spain: Ministry of Health
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration