Biologic Treatment Registry Across Canada

Conditions

Arthritis, Psoriatic, Arthritis, Rheumatoid, Spondyloarthritis, Axial

Keywords

Rheumatoid arthritis; psoriatic arthritis; axial spondyloarthritis, Remicade®, Simponi®, Simponi® I.V, Stelara®, Registry, BioTRAC

Brief summary

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

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

Arendse R, Rahman P, Baer P, Haaland D, Bessette L, Sholter D, Rachich M, Rampakakis E, Marrache AM, Lehman AJ, Asin-Milan O.

2025-09-19

10.1007/s40744-025-00788-0

Real-World Incidence and Determinants of Infection in Patients With Rheumatoid Arthritis Treated With Golimumab After a Median Follow-Up Time of 27 Months

Louis Bessette, Proton Rahman, J. Kelsall, Jane Purvis, Emmanouil Rampakakis et al. (10 authors)

The Journal of Rheumatology2023-06-011 citations

10.3899/jrheum.2022-1283

Long-term effectiveness and safety of infliximab and golimumab in ankylosing spondylitis patients from a Canadian prospective observational registry.

Rahman P, Starr M, Haaland D, Bessette L, Teo M, Rampakakis E, Lehman AJ, Nantel F.

2020-11-154 citations

10.1186/s41927-020-00158-z

Long-term effectiveness and safety of infliximab, golimumab and golimumab-IV in rheumatoid arthritis patients from a Canadian prospective observational registry.

Rahman P, Baer P, Keystone E, Choquette D, Thorne C, Haraoui B, Chow A, Faraawi R, Olszynski W, Kelsall J, Rampakakis E, Lehman AJ, Nantel F.

2020-09-199 citations

10.1186/s41927-020-00145-4

Long-term effectiveness and safety of infliximab, golimumab and ustekinumab in patients with psoriatic arthritis from a Canadian prospective observational registry

Proton Rahman, R. Arendse, Majed Khraishi, D. Sholter, M. Sheriff et al. (8 authors)

BMJ Open2020-08-0110 citations

10.1136/bmjopen-2019-036245

Real-world validation of the minimal disease activity index in psoriatic arthritis: an analysis from a prospective, observational, biological treatment registry

Proton Rahman, Michel Zummer, Louis Bessette, P. Baer, Boulos Haraoui et al. (14 authors)

BMJ Open2017-08-0125 citations

10.1136/bmjopen-2017-016619

Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis

Proton Rahman, D. Choquette, W. Bensen, Majed Khraishi, Andrew Chow et al. (18 authors)

BMJ Open2016-04-0114 citations

10.1136/bmjopen-2015-009661

Use of corticosteroids in patients with rheumatoid arthritis treated with infliximab: treatment implications based on a real-world Canadian population

Boulos Haraoui, A. Jovaisas, W. Bensen, R. Faraawi, J. Kelsall et al. (14 authors)

RMD Open2015-04-0124 citations

10.1136/rmdopen-2015-000078

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Disease Status of Canadian Participants With Rheumatic Disease Treated With Infliximab	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	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)	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	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.

Secondary

Measure	Time frame	Description
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	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	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	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	Up to 4 years	Provides expanded data to health care providers and hospitals to estimate and support appropriate use of Ustekinumab.

Countries

Canada

Outcome results