Biologic Rheumatology Registry Across Canada (BioTRAC)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2015 by Janssen Inc.
Sponsor:
Janssen Inc.
Information provided by (Responsible Party):
Janssen Inc.
ClinicalTrials.gov Identifier:
NCT00741793
First received: August 22, 2008
Last updated: February 19, 2015
Last verified: February 2015
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Purpose
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 Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | BioTRAC (BIOLOGIC TREATMENT REGISTRY ACROSS CANADA) Rheumatology (Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis) |
Resource links provided by NLM:
Genetics Home Reference related topics:
ankylosing spondylitis
psoriatic arthritis
rheumatoid arthritis
U.S. FDA Resources
Further study details as provided by Janssen Inc.:
Primary Outcome Measures:
- Disease status of Canadian subjects treated with infliximab or golimumab [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 3000 |
| 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Participants with RA, AS, or PsA will be selected primarily from community centers and some academic centers.
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741793
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741793
Contacts
| 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 |
Locations
| Canada, Quebec | |
| Recruiting | |
| Montreal, Quebec, Canada | |
Sponsors and Collaborators
Janssen Inc.
Investigators
| Study Director: | Janssen Inc. Clinical Trial | Janssen Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Janssen Inc. |
| ClinicalTrials.gov Identifier: | NCT00741793 History of Changes |
| Other Study ID Numbers: | CR100762, P02843 |
| Study First Received: | August 22, 2008 |
| Last Updated: | February 19, 2015 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Janssen Inc.:
|
Rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis Remicade® Simponi® registry BioTRAC |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Spondylitis Spondylitis, Ankylosing Ankylosis Autoimmune Diseases Bone Diseases Bone Diseases, Infectious Connective Tissue Diseases Immune System Diseases |
Infection Joint Diseases Musculoskeletal Diseases Psoriasis Rheumatic Diseases Skin Diseases Skin Diseases, Papulosquamous Spinal Diseases Spondylarthritis Spondylarthropathies |
ClinicalTrials.gov processed this record on February 25, 2015