Remicade Infusion Management Program

Crohn Disease Clinical Trial

— RemiTRAC  

Official title:

Remicade Infusion Management Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723905
• Other study ID #: CR100746
• Secondary ID: P04466
• Status: Completed
• Phase: Phase 4
• First received: July 25, 2008
• Last updated: January 14, 2013
• Start date: August 2005
• Est. completion date: October 2012

Study information

• Verified date: January 2013
• Source: Janssen Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

Janssen Inc. plans to collect data on about 3000 to 5000 infliximab infusions per year, starting in the third quarter of 2005. It is expected that about 12 sites from the Remicade Infusion Network (R.I.N.) will participate. This registry will be a multicentre, prospective, observational program that will gather and analyze data on subjects being treated with infliximab.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1630
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subject is a good candidate to receive infliximab as per the Product Monograph

• Subject is prescribed infliximab by an appropriate physician

• Subject receives infusion in a community infusion centre.

• Subject has signed the approved consent form.

Exclusion Criteria:

• Not specified in the protocol

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Crohn Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type and frequency of infusion reactions		Up to 7 years	No
Primary	Pre-infusion treatments and efficacy		Up to 7 years	No
Primary	Infusion reaction management approaches		Up to 7 years	No
Primary	The number of subjects with adverse events		Up to 7 years	No