Biologic Treatment Registry Across Canada

Study Overview
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Brief Summary
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This registry is a multi-center, prospective, longitudinal, observational program that will gather and analyse data on participants treated with infliximab, golimumab, golimumab Intravenous (I.V) or ustekinumab. Treatment will be prescribed by the physician according to actual clinical practice or standard of care for Rheumatoid Arthritis (RA), Axial Spondyloarthritis (AxSpA) , Psoriatic Arthritis (PsA); there will be no randomized assignments to treatment. At baseline and approximately every 6 months thereafter, information will be collected to assess safety, clinical outcomes, quality of life, comorbidities, pharmacoeconomics and treatment regimens among cohorts of participants receiving infliximab, golimumab, golimumab I.V or ustekinumab for the treatment of RA, AxSpA and PsA.

Detailed Description
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Participants will be selected for this registry using a non-probability sampling method.

Official Title
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BioTRAC (BIOLOGIC TREATMENT REGISTRY ACROSS CANADA)

Conditions
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Arthritis, Rheumatoid, Spondyloarthritis, Axial, Arthritis, Psoriatic

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Status of Canadian Participants With Rheumatic Disease Treated With Infliximab | Physician will rate arthritis activity using Visual Analog Scale (VAS) ranging from 0 to 100; higher scores indicated greater affectation due to disease activity. | Up to 4 years | 
| Disease Status of Canadian Participants With Rheumatic Disease Treated With Golimumab | Physician will rate arthritis activity using VAS ranging from 0 to 100; higher scores indicated greater affectation due to disease activity. | Up to 4 years | 
| Disease Status of Canadian Participants With Rheumatic Disease Treated With Golimumab Intravenous (I.V) | Physician will rate arthritis activity using VAS ranging from 0 to 100; higher scores indicated greater affectation due to disease activity. | Up to 4 years | 
| Disease Status of Canadian Participants With Rheumatic Disease Treated With Ustekinumab | Physician will rate arthritis activity using VAS ranging from 0 to 100; higher scores indicated greater affectation due to disease activity. | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants With Adverse Events |  | Up to 4 years | 
| Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Infliximab | Provides expanded data to health care providers and hospitals to estimate and support appropriate use of Infliximab. | Up to 4 years | 
| Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Golimumab | Provides expanded data to health care providers and hospitals to estimate and support appropriate use of Golimumab. | Up to 4 years | 
| Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Golimumab I.V | Provides expanded data to health care providers and hospitals to estimate and support appropriate use of Golimumab I.V. | Up to 4 years | 
| Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Ustekinumab | Provides expanded data to health care providers and hospitals to estimate and support appropriate use of Ustekinumab. | Up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis; psoriatic arthritis; axial spondyloarthritis, Remicade®, Simponi®, Simponi® I.V, Stelara®, Registry, BioTRAC