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OpenTrials
Completed

NCT Number: NCT00741793

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.

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Key information

Conditions

Arthritis, Rheumatoid Ankylosis Arthritis Arthritis, Psoriatic Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Rheumatic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondyloarthritis, Axial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal, Quebec, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. The Number of Participants With Adverse Events

    Time frame: Up to 4 years

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Janssen Inc.

Industry

Registry information

Official study title

BioTRAC (BIOLOGIC TREATMENT REGISTRY ACROSS CANADA)

Acronym: BioTRAC

Important dates

Study start
2002
Primary completion
2018
Study completion
2018
First posted
Aug 26, 2008
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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