Remicade® Crohn's Disease Registry Across Canada (Study P02793)

Study Overview
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Brief Summary
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This registry is a multi-center, prospective, observational program that will gather and analyze data on subjects with Crohn's disease being treated with Remicade® as per approved product monograph in Canada. In contrast to a controlled clinical trial, there is no imposed experimental intervention and treatment with Remicade® is determined solely by the subject's physicians. Thus, the data captured and reported in this registry will reflect a real world approach to the treatment of Crohn's disease with Remicade®.

Detailed Description
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Subjects will be selected for this registry using a non-probability sampling method.

Official Title
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Remicade® Treatment Registry Across Canada in Crohn's Disease

Conditions
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Crohn's Disease

Intervention / Treatment
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* Other: Data collection post infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient was given the Patient Information Brochure; AND, Patient has never been treated with Remicade® (patient is naïve to Remicade® at the time of registration); AND, Patient is a good candidate to receive Remicade® as per the product monograph; AND, Patient has agreed to complete the Patient Diary for one week prior to each visit in the registry; AND, Patient has signed the approved consent form. Exclusion Criteria: Per product monograph
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects receiving Remicade<br>Crohn's disease subjects receiving Remicade® per Product Monograph. | Other: Data collection post infusion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline). | 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. | 12 months after baseline | 
| Clinical Response at 24 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline). | 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. | 24 months after baseline | 
| Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline). | 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. | 36 months after baseline | 
| Clinical Remission at 12 Months (CDAI <= 150 Points). | 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. | 12 months after baseline | 
| Clinical Remission at 24 Months (CDAI <= 150 Points). | 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. | 24 months after baseline | 
| Clinical Remission at 36 Months (CDAI <= 150 Points). | 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. | 36 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Serious Adverse Events |  | Throughout study (up to 36 months) |