Biologic Rheumatology Registry Across Canada (BioTRAC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Janssen Inc.
Sponsor:
Information provided by (Responsible Party):
Janssen Inc.
ClinicalTrials.gov Identifier:
NCT00741793
First received: August 22, 2008
Last updated: August 7, 2014
Last verified: August 2014

August 22, 2008
August 7, 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 ClinicalTrials.gov 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 ]
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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
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.
 
Recruiting
3000
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
Both
Not Provided
No
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: JNJ.CT@sylogent.com
Canada
 
NCT00741793
CR100762, P02843
No
Janssen Inc.
Janssen Inc.
Not Provided
Study Director: Janssen Inc. Clinical Trial Janssen Inc.
Janssen Inc.
August 2014

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