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A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease (PRECiSE 4)

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ClinicalTrials.gov Identifier: NCT00160706
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : July 4, 2013
Last Update Posted : July 4, 2013
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Crohn's Disease
Intervention: Biological: Certolizumab Pegol (CDP870)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

This multicenter study started to enroll subjects in February 2004 in order to end up with 141 centers in 24 countries with enrolled subjects.

Participant Flow refers to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who withdrew from feeder studies for worsening of Crohn’s Disease entered study C87034. Subjects in study C87031 were eligible for entry into C87034 at any time after completing the Week 2 assessment, subjects in study C87032 at any time after completing the Week 6 randomisation.

Reporting Groups
  Description
Certolizumab Pegol

3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.

Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.

Up to 84 months of therapy in this study.


Participant Flow:   Overall Study
    Certolizumab Pegol
STARTED   310 
COMPLETED   24 
NOT COMPLETED   286 
Adverse Event                53 
Adverse Event and Other Reason                105 
Protocol Violation                3 
Withdrawal by Subject                41 
Withdrawal by Subject and Other                12 
Physician Decision                10 
Physician Decision and Other                3 
Lost to Follow-up                4 
Lost to Follow-up and Other                1 
Lack of Efficacy                42 
Lack of Efficacy and Other                1 
Other Reason                11 



  Baseline Characteristics

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 one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].

Reporting Groups
  Description
Certolizumab Pegol

3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.

Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.

Up to 84 months of therapy in this study.


Baseline Measures
   Certolizumab Pegol 
Overall Participants Analyzed 
[Units: Participants]
 310 
Age 
[Units: Participants]
 
<=18 years   2 
Between 18 and 65 years   299 
>=65 years   9 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.5  (11.67) 
Gender 
[Units: Participants]
 
Female   179 
Male   131 
Region of Enrollment 
[Units: Participants]
 
Serbia   4 
United States   74 
Belarus   2 
Estonia   5 
Slovenia   3 
Spain   1 
Ukraine   3 
Austria   7 
Russian Federation   17 
Israel   5 
Italy   5 
Czech Republic   10 
Hungary   13 
Canada   9 
Poland   10 
Belgium   8 
Singapore   2 
Australia   43 
Denmark   11 
South Africa   31 
Bulgaria   1 
Norway   7 
Germany   29 
New Zealand   10 


  Outcome Measures

1.  Primary:   Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months)   [ Time Frame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372) ]

2.  Primary:   Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months)   [ Time Frame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372) ]

3.  Secondary:   Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit   [ Time Frame: Study Completion Visit (Week 362) / (Early) Withdrawal Visit ]

4.  Secondary:   Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032   [ Time Frame: From Baseline of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 362) or (Early) Withdrawal Visit of this study (up to 90 months) ]

5.  Secondary:   Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of CDP870-034   [ Time Frame: From Week 0 of study CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months) ]

6.  Secondary:   Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit   [ Time Frame: Study Completion Visit (Week 362) / (Early) Withdrawal Visit ]

7.  Secondary:   Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034   [ Time Frame: From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months) ]

8.  Secondary:   C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit   [ Time Frame: Study Completion Visit (Week 362) / (Early) Withdrawal Visit ]

9.  Secondary:   Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256   [ Time Frame: Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256 ]


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information

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 Clinical Trial Call Center
Organization: UCB
phone: +1 877 822 9493 (UCB)


Publications of Results:

Responsible Party: UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT00160706     History of Changes
Other Study ID Numbers: C87034
2005-002623-13 ( EudraCT Number )
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: May 16, 2013
Results First Posted: July 4, 2013
Last Update Posted: July 4, 2013