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

Crohn's Disease Clinical Trial

— RemiTRAC®  

Official title:

Remicade® Treatment Registry Across Canada in Crohn's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00755937
• Other study ID #: P02793
• Status: Terminated
• Phase: N/A
• First received: August 26, 2008
• Last updated: May 26, 2015
• Start date: February 2002
• Est. completion date: September 2007

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

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®.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 556
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Other:
• Data collection post infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Number of Serious Adverse Events		Throughout study (up to 36 months)	No