Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Remicade Infusion Management Program (RemiTRAC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Inc.
ClinicalTrials.gov Identifier:
NCT00723905
First received: July 25, 2008
Last updated: January 14, 2013
Last verified: January 2013

July 25, 2008
January 14, 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 ] [ Designated as safety issue: No ]
  • Pre-infusion treatments and efficacy [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • Infusion reaction management approaches [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • The number of subjects with adverse events [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • To accurately define the types and frequency of infusion reactions. [ Time Frame: At each infusion following treatment administration (as per product monograph) ] [ Designated as safety issue: Yes ]
  • To collect information on pre-infusion treatments and their efficacy. [ Time Frame: At each infusion following treatment administration (as per product monograph) ] [ Designated as safety issue: No ]
  • To collect information on infusion reaction management approaches [ Time Frame: At each infusion following treatment administration (as per product monograph) ] [ Designated as safety issue: Yes ]
  • To follow up on safety parameters in subjects treated with infliximab [ Time Frame: At each infusion following treatment administration (as per product monograph) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00723905 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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
Not Provided
Not Provided
Not Provided

*   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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00723905
CR100746, P04466
No
Janssen Inc.
Janssen Inc.
Not Provided
Study Director: Janssen Inc. Clinical Trial Janssen Inc.
Janssen Inc.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP