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Biologic Rheumatology Registry Across Canada (BioTRAC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Janssen Inc.
Information provided by (Responsible Party):
Janssen Inc. Identifier:
First received: August 22, 2008
Last updated: November 5, 2014
Last verified: November 2014

August 22, 2008
November 5, 2014
October 2010
April 2018   (final data collection date for primary outcome measure)
Disease status of Canadian subjects treated with infliximab or golimumab [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
To follow up on efficacy parameters in Canadian subjects treated with Remicade®. [ Time Frame: From baseline, evaluations are conducted every 6 months. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00741793 on Archive Site
  • The number of subjects with adverse events [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Expanded information and support for healthcare providers and hospitals about the appropriate use of infliximab and golimumab [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • To follow up on safety parameters in Canadian subjects treated with Remicade®. [ Time Frame: From baseline, evaluations are conducted every 6 months. ] [ Designated as safety issue: Yes ]
  • To provide expanded data to healthcare providers and hospitals to estimate and support appropriate use of Remicade. [ Time Frame: 2-4 times a year ] [ Designated as safety issue: No ]
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Biologic Rheumatology Registry Across Canada
BioTRAC (BIOLOGIC TREATMENT REGISTRY ACROSS CANADA) Rheumatology (Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis)

This registry is a multi-center, prospective, observational program that will gather and analyze data on subjects being treated with infliximab and golimumab for rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PsA). In contrast to a controlled clinical trial, there is no imposed experimental intervention and the subjects' physicians solely will determine the subject's treatment. Thus, the data captured and reported in this registry will reflect a "real world" approach to treatment with infliximab or golimumab.

Subjects will be selected for this registry using a non-probability sampling method.

Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Participants with RA, AS, or PsA will be selected primarily from community centers and some academic centers.

  • Arthritis, Rheumatoid
  • Spondylitis, Ankylosing
  • Arthritis, Psoriatic
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2018
April 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participant is starting infliximab or golimumab at the time of enrollment or has been treated with one other prior biologic (including infliximab and golimumab) within the 6 months prior to enrollment
  • Participant has been diagnosed with RA, AS or PsA and is eligible for treatment with infliximab or golimumab as per the Product Monograph

Exclusion Criteria:

  • Participant was treated with any biologic, for any period of time, prior to 6 months before enrollment
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Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
CR100762, P02843
Janssen Inc.
Janssen Inc.
Not Provided
Study Director: Janssen Inc. Clinical Trial Janssen Inc.
Janssen Inc.
November 2014

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