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Remicade Infusion Management Program (RemiTRAC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00723905
First Posted: July 29, 2008
Last Update Posted: January 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen Inc.
July 25, 2008
July 29, 2008
January 15, 2013
August 2005
October 2012   (Final data collection date for primary outcome measure)
  • Type and frequency of infusion reactions [ Time Frame: Up to 7 years ]
  • Pre-infusion treatments and efficacy [ Time Frame: Up to 7 years ]
  • Infusion reaction management approaches [ Time Frame: Up to 7 years ]
  • The number of subjects with adverse events [ Time Frame: Up to 7 years ]
  • To accurately define the types and frequency of infusion reactions. [ Time Frame: At each infusion following treatment administration (as per product monograph) ]
  • To collect information on pre-infusion treatments and their efficacy. [ Time Frame: At each infusion following treatment administration (as per product monograph) ]
  • To collect information on infusion reaction management approaches [ Time Frame: At each infusion following treatment administration (as per product monograph) ]
  • To follow up on safety parameters in subjects treated with infliximab [ Time Frame: At each infusion following treatment administration (as per product monograph) ]
Complete list of historical versions of study NCT00723905 on ClinicalTrials.gov Archive Site
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Remicade Infusion Management Program
Remicade Infusion Management Program
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
The data captured and reported in this registry will reflect a "real world" approach to the treatment of Rheumatoid Arthritis and Crohn's Disease with infliximab.
  • Crohn Disease
  • Arthritis, Rheumatoid
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Choquette D, Faraawi R, Chow A, Rodrigues J, Bensen WJ, Nantel F. Incidence and Management of Infusion Reactions to Infliximab in a Prospective Real-world Community Registry. J Rheumatol. 2015 Jul;42(7):1105-11. doi: 10.3899/jrheum.140538. Epub 2015 Jun 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1630
October 2012
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00723905
CR100746
P04466 ( Other Identifier: Janssen Inc. )
No
Not Provided
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Janssen Inc.
Janssen Inc.
Not Provided
Study Director: Janssen Inc. Clinical Trial Janssen Inc.
Janssen Inc.
January 2013