Remicade Infusion Management Program

Completed

• Conditions: Crohn Disease; Arthritis, Rheumatoid

• Registration Number: NCT00723905
• Lead Sponsor: Janssen Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-14
• Last Update Posted: 2013-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1630

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Type and frequency of infusion reactions	Up to 7 years
Pre-infusion treatments and efficacy	Up to 7 years
Infusion reaction management approaches	Up to 7 years
The number of subjects with adverse events	Up to 7 years