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

Remicade® Treatment Registry Across Canada in Crohn's Disease

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®.

Study Overview

• Status: Terminated
• Conditions: Crohn's Disease
• Intervention / Treatment: Other: Data collection post infusion

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 556

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primarily from community centers and some academic centers.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects receiving Remicade; Crohn's disease subjects receiving Remicade® per Product Monograph.	Other: Data collection post infusion

What is the study measuring?

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	Time Frame
Number of Serious Adverse Events	Throughout study (up to 36 months)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2002
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: August 26, 2008
• First Submitted That Met QC Criteria: September 17, 2008
• First Posted (Estimate): September 19, 2008

Study Record Updates

• Last Update Posted (Estimate): June 22, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: P02793