Text Size

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
  Hide 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 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
  Hide Baseline Characteristics

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
  Show All Outcome Measures

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 ]
  Show Outcome Measure 6

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 ]
  Show Outcome Measure 8

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 ]
  Show Outcome Measure 10

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 ]
  Show Outcome Measure 14

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
  Show Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame Maximum of 166 weeks
Additional Description Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Certolizumab Pegol 400 mg  
Total, other (not including serious) adverse events    
# participants affected / at risk     190/229  
Gastrointestinal disorders    
Abdominal pain * 1  
# participants affected / at risk     45/229 (19.65%)  
# events     63  
Abdominal pain upper * 1  
# participants affected / at risk     18/229 (7.86%)  
# events     23  
Anal fissure * 1  
# participants affected / at risk     14/229 (6.11%)  
# events     16  
Constipation * 1  
# participants affected / at risk     14/229 (6.11%)  
# events     20  
Crohn's disease * 1  
# participants affected / at risk     41/229 (17.90%)  
# events     48  
Diarrhoea * 1  
# participants affected / at risk     33/229 (14.41%)  
# events     44  
Haematochezia * 1  
# participants affected / at risk     14/229 (6.11%)  
# events     16  
Nausea * 1  
# participants affected / at risk     23/229 (10.04%)  
# events     43  
Vomiting * 1  
# participants affected / at risk     24/229 (10.48%)  
# events     34  
General disorders    
Asthenia * 1  
# participants affected / at risk     12/229 (5.24%)  
# events     15  
Fatigue * 1  
# participants affected / at risk     21/229 (9.17%)  
# events     29  
Pyrexia * 1  
# participants affected / at risk     47/229 (20.52%)  
# events     93  
Infections and infestations    
Bronchitis * 1  
# participants affected / at risk     23/229 (10.04%)  
# events     33  
Gastroenteritis * 1  
# participants affected / at risk     16/229 (6.99%)  
# events     20  
Herpes simplex * 1  
# participants affected / at risk     24/229 (10.48%)  
# events     39  
Influenza * 1  
# participants affected / at risk     30/229 (13.10%)  
# events     35  
Nasopharyngitis * 1  
# participants affected / at risk     63/229 (27.51%)  
# events     117  
Sinusitis * 1  
# participants affected / at risk     23/229 (10.04%)  
# events     30  
Upper respiratory tract infection * 1  
# participants affected / at risk     12/229 (5.24%)  
# events     15  
Urinary tract infection * 1  
# participants affected / at risk     19/229 (8.30%)  
# events     31  
Musculoskeletal and connective tissue disorders    
Arthralgia * 1  
# participants affected / at risk     44/229 (19.21%)  
# events     68  
Back pain * 1  
# participants affected / at risk     27/229 (11.79%)  
# events     31  
Muscle spasms * 1  
# participants affected / at risk     12/229 (5.24%)  
# events     16  
Pain in extremity * 1  
# participants affected / at risk     12/229 (5.24%)  
# events     19  
Nervous system disorders    
Headache * 1  
# participants affected / at risk     47/229 (20.52%)  
# events     80  
Respiratory, thoracic and mediastinal disorders    
Cough * 1  
# participants affected / at risk     28/229 (12.23%)  
# events     31  
Pharyngolaryngeal pain * 1  
# participants affected / at risk     21/229 (9.17%)  
# events     27  
Skin and subcutaneous tissue disorders    
Rash * 1  
# participants affected / at risk     20/229 (8.73%)  
# events     37  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (9.0)



  More Information
  Hide 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 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