Biologic Treatment Registry Across Canada (BioTRAC)

April 25, 2025 updated by: Janssen Inc.

BioTRAC (BIOLOGIC TREATMENT REGISTRY ACROSS CANADA)

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

2821

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Quebec
  - Montreal, Quebec, Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Participants with RA, AxSpA, or PsA will be selected primarily from community centers and some academic centers.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 4 years
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.	Up to 4 years
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.	Up to 4 years
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.	Up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Participants With Adverse Events Time Frame: Up to 4 years		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.	Up to 4 years
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.	Up to 4 years
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.	Up to 4 years
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.	Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Inc.

Investigators

Study Director: Janssen Inc. Clinical Trial, Janssen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2002

Primary Completion (Actual)

June 27, 2018

Study Completion (Actual)

June 29, 2018

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria