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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00723905
Date of registration: 25/07/2008
Prospective Registration: No
Primary sponsor: Janssen Inc.
Public title: Remicade Infusion Management Program RemiTRAC
Scientific title: Remicade Infusion Management Program
Date of first enrolment: August 2005
Target sample size: 1630
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00723905
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Phase: 
Countries of recruitment
Canada
Contacts
Name:     Janssen Inc. Clinical Trial
Address: 
Telephone:
Email:
Affiliation:  Janssen Inc.
Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Arthritis, Rheumatoid
Crohn Disease
Intervention(s)
Primary Outcome(s)
Type and frequency of infusion reactions [Time Frame: Up to 7 years]
Infusion reaction management approaches [Time Frame: Up to 7 years]
Pre-infusion treatments and efficacy [Time Frame: Up to 7 years]
The number of subjects with adverse events [Time Frame: Up to 7 years]
Secondary Outcome(s)
Secondary ID(s)
CR100746
P04466
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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