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OpenTrials
Completed

NCT Number: NCT00723905

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Type and frequency of infusion reactions

    Time frame: Up to 7 years

  2. Pre-infusion treatments and efficacy

    Time frame: Up to 7 years

  3. Infusion reaction management approaches

    Time frame: Up to 7 years

  4. The number of subjects with adverse events

    Time frame: Up to 7 years

Sponsors and collaborators

Lead sponsor

Janssen Inc.

Industry

Registry information

Acronym: RemiTRAC

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Jul 29, 2008
Registry last updated
Jan 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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