Biologic Treatment Registry Across Canada (BioTRAC)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00741793 |
Recruitment Status :
Completed
First Posted : August 26, 2008
Last Update Posted : September 24, 2019
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Condition or disease |
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Arthritis, Rheumatoid Spondyloarthritis, Axial Arthritis, Psoriatic |
Study Type : | Observational |
Actual Enrollment : | 2821 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | BioTRAC (BIOLOGIC TREATMENT REGISTRY ACROSS CANADA) |
Actual Study Start Date : | February 12, 2002 |
Actual Primary Completion Date : | June 27, 2018 |
Actual Study Completion Date : | June 29, 2018 |

- Disease Status of Canadian Participants With Rheumatic Disease Treated With Infliximab [ Time Frame: Up to 4 years ]Physician will rate arthritis activity using Visual Analog Scale (VAS) ranging from 0 to 100; higher scores indicated greater affectation due to disease activity.
- Disease Status of Canadian Participants With Rheumatic Disease Treated With Golimumab [ Time Frame: Up to 4 years ]Physician will rate arthritis activity using VAS ranging from 0 to 100; higher scores indicated greater affectation due to disease activity.
- Disease Status of Canadian Participants With Rheumatic Disease Treated With Golimumab Intravenous (I.V) [ Time Frame: Up to 4 years ]Physician will rate arthritis activity using VAS ranging from 0 to 100; higher scores indicated greater affectation due to disease activity.
- Disease Status of Canadian Participants With Rheumatic Disease Treated With Ustekinumab [ Time Frame: Up to 4 years ]Physician will rate arthritis activity using VAS ranging from 0 to 100; higher scores indicated greater affectation due to disease activity.
- The Number of Participants With Adverse Events [ Time Frame: Up to 4 years ]
- Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Infliximab [ Time Frame: Up to 4 years ]Provides expanded data to health care providers and hospitals to estimate and support appropriate use of Infliximab.
- Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Golimumab [ Time Frame: Up to 4 years ]Provides expanded data to health care providers and hospitals to estimate and support appropriate use of Golimumab.
- Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Golimumab I.V [ Time Frame: Up to 4 years ]Provides expanded data to health care providers and hospitals to estimate and support appropriate use of Golimumab I.V.
- Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Ustekinumab [ Time Frame: Up to 4 years ]Provides expanded data to health care providers and hospitals to estimate and support appropriate use of Ustekinumab.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Participant is starting infliximab, golimumab, golimumab Intravenous (I.V) or ustekinumab at the time of enrollment and is biologic naive or has been treated with only one prior biologic (including infliximab, golimumab, golimumab I.V or ustekinumab) prior to enrollment
- Participant has signed the approved informed consent form
- Participant is diagnosed with RA, AxSpA or PsA and is eligible for treatment with infliximab, golimumab, golimumab I.V or ustekinumab in accordance with routine clinical care and the Canadian Product Monograph.
Exclusion Criteria:
- Participant was treated with two or more biologics, for any period of time before enrollment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741793
Canada, Quebec | |
Montreal, Quebec, Canada |
Study Director: | Janssen Inc. Clinical Trial | Janssen Inc. |
Responsible Party: | Janssen Inc. |
ClinicalTrials.gov Identifier: | NCT00741793 |
Other Study ID Numbers: |
CR100762 P02843 ( Other Identifier: Janssen Inc. ) |
First Posted: | August 26, 2008 Key Record Dates |
Last Update Posted: | September 24, 2019 |
Last Verified: | September 2019 |
Studies a U.S. FDA-regulated Device Product: | No |
Rheumatoid arthritis; psoriatic arthritis; axial spondyloarthritis Remicade® Simponi® Simponi® I.V |
Stelara® Registry BioTRAC |
Spondylitis Arthritis Spondylarthritis Arthritis, Rheumatoid Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Bone Diseases, Infectious Infections Bone Diseases |
Spinal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Spondylarthropathies Psoriasis Skin Diseases, Papulosquamous Skin Diseases |