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Remicade® Crohn's Disease Registry Across Canada (Study P02793AM2)(COMPLETED) (RemiTRAC®)

This study has been terminated.
(Satisfied a post-marketing commitment to Canadian Health Authorities.)
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00755937
First received: August 26, 2008
Last updated: October 9, 2009
Last verified: October 2009
History of Changes
Results First Received: September 29, 2008  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Crohn's Disease
Intervention: Other: Data collection post infusion

  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 was an observational trial/registry. Recruitment began in 2002. Subjects were drawn from community centers and some academic centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not applicable for an observational trial. Subjects were not assigned to treatment, but received infliximab only if their physician had decided to treat with infliximab.

Reporting Groups
  Description
Subjects Receiving Remicade Crohn's disease subjects who were to receive Remicade® per Product Monograph.

Participant Flow for 2 periods

 Period 1:   Recruitment
    Subjects Receiving Remicade  
STARTED     556 [1]
COMPLETED     392 [2]
NOT COMPLETED     164  
Unknown if infiximab received                 164  
[1] Subjects registered in the program
[2] Subjects who had a baseline visit and at least 1 additional follow-up visit (analyzed population)

Period 2:   Observational Follow-up
    Subjects Receiving Remicade  
STARTED     392  
COMPLETED     244 [1]
NOT COMPLETED     148  
Lost to Follow-up                 148  
[1] Subjects followed until end of study/subjects for whom end of participation data were collected



  Baseline Characteristics
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Reporting Groups
  Description
Subjects Receiving Remicade Crohn's disease subjects who were to receive Remicade® per Product Monograph.

Baseline Measures
    Subjects Receiving Remicade  
Number of Participants  
[units: participants]
 		  556  
Age  
[units: years]
Mean ± Standard Deviation 		  37.5  ± 12.8  
Gender  
[units: participants]
 		 
Female     314  
Male     242  
Region of Enrollment  
[units: participants]
 		 
Canada     556  



  Outcome Measures
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1.  Primary:   Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline).   [ Time Frame: 12 months after baseline ]
  Show Outcome Measure 1

2.  Primary:   Clinical Response at 24 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).   [ Time Frame: 24 months after baseline ]
  Show Outcome Measure 2

3.  Primary:   Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).   [ Time Frame: 36 months after baseline ]
  Show Outcome Measure 3

4.  Primary:   Clinical Remission at 12 Months (CDAI <= 150 Points).   [ Time Frame: 12 months after baseline ]
  Show Outcome Measure 4

5.  Primary:   Clinical Remission at 24 Months (CDAI <= 150 Points).   [ Time Frame: 24 months after baseline ]
  Hide Outcome Measure 5

Measure Type Primary
Measure Title Clinical Remission at 24 Months (CDAI <= 150 Points).
Measure Description CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.
Time Frame 24 months after baseline  
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.
Patients at 24 months: Patients with at least 24 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.

Reporting Groups
  Description
Subjects Receiving Remicade Crohn's disease subjects who were to receive Remicade® per Product Monograph.

Measured Values
    Subjects Receiving Remicade  
Number of Participants Analyzed  
[units: participants]
 		  91  
Clinical Remission at 24 Months (CDAI <= 150 Points).  
[units: Participants]
 		  59  


Statistical Analysis 1 for Clinical Remission at 24 Months (CDAI <= 150 Points).
Groups [1] Subjects Receiving Remicade
Percentage (no inferential test) [2] 64.8
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



6.  Primary:   Clinical Remission at 36 Months (CDAI <= 150 Points).   [ Time Frame: 36 months after baseline ]
  Show Outcome Measure 6

7.  Secondary:   Number of Serious Adverse Events   [ Time Frame: Throughout study (up to 36 months) ]
  Show Outcome Measure 7


  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 NOT 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.


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
This was an observational study. There were no imposed interventions from the Sponsor including imposing specific duration of treatment or data collection beyond the standard of care.  


Results Point of Contact:  
Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00755937     History of Changes
Other Study ID Numbers: P02793
Study First Received: August 26, 2008
Results First Received: September 29, 2008
Last Updated: October 9, 2009
Health Authority: Canada: Health Canada