Biologic Rheumatology Registry Across Canada (BioTRAC)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||BioTRAC (BIOLOGIC TREATMENT REGISTRY ACROSS CANADA) Rheumatology (Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis)|
- Disease status of Canadian subjects treated with infliximab or golimumab [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2018 (Final data collection date for primary outcome measure)|
Subjects will be selected for this registry using a non-probability sampling method.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741793
|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|
|Montreal, Quebec, Canada|
|Study Director:||Janssen Inc. Clinical Trial||Janssen Inc.|