AzTrials
AzTrials

Arthritis, RheumatoidBioTRACNCT00741793

Biologic Treatment Registry Across Canada

An observational study of Arthritis, Rheumatoid and Spondyloarthritis, Axial, run by Janssen Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
2,821 participants
Where
1 siteCanada
Study dates
12 Feb 2002to 29 Jun 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • Participant was treated with two or more biologics, for any period of time before enrollment

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Study site

    Montreal, Quebec

Other trials in Canada

About this study

Official title: 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.

Read the detailed description

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

Keywords
Rheumatoid arthritis; psoriatic arthritis; axial spondyloarthritis, Remicade®, Simponi®, Simponi® I.V, Stelara®, Registry, BioTRAC
Medical subject headings
Arthritis, Rheumatoid, Axial Spondyloarthritis, Arthritis, Psoriatic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 4 years

  2. 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.

    Measured: Up to 4 years

  3. 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.

    Measured: Up to 4 years

  4. 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.

    Measured: Up to 4 years

Secondary outcomes (5)

  1. The Number of Participants With Adverse Events

    Measured: Up to 4 years

  2. 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.

    Measured: Up to 4 years

  3. 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.

    Measured: Up to 4 years

  4. 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.

    Measured: Up to 4 years

  5. 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.

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2008 (estimated)
  2. Study start12 Feb 2002
  3. Primary completion27 Jun 2018
  4. Study completion29 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,821 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00741793
Sponsor's protocol ID
CR100762
Other IDs
P02843
Acronym
BioTRAC
Status last verified
Apr 2025
First submitted
22 Aug 2008
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated device
No

Publications

  • Arendse R, Rahman P, Baer P, Haaland D, Bessette L, Sholter D, Rachich M, Rampakakis E, Marrache AM, Lehman AJ, Asin-Milan O. Safety of Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Axial Spondyloarthritis: Results from a Real-World Canadian Setting. Rheumatol Ther. 2025 Dec;12(6):1043-1055. doi: 10.1007/s40744-025-00788-0. Epub 2025 Sep 19.

    PubMed 40971024

  • Bessette L, Rahman P, Kelsall J, Purvis J, Rampakakis E, Lehman AJ, Rachich M, Nantel F, Asin-Milan O, Marrache AM. Real-World Incidence and Determinants of Infection in Patients With Rheumatoid Arthritis Treated With Golimumab After a Median Follow-Up Time of 27 Months. J Rheumatol. 2023 Sep;50(9):1121-1126. doi: 10.3899/jrheum.2022-1283. Epub 2023 Jun 1.

    PubMed 37263649

  • Rahman P, Starr M, Haaland D, Bessette L, Teo M, Rampakakis E, Lehman AJ, Nantel F. Long-term effectiveness and safety of infliximab and golimumab in ankylosing spondylitis patients from a Canadian prospective observational registry. BMC Rheumatol. 2020 Nov 15;4(1):56. doi: 10.1186/s41927-020-00158-z.

    PubMed 33292797

  • 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. Long-term effectiveness and safety of infliximab, golimumab and golimumab-IV in rheumatoid arthritis patients from a Canadian prospective observational registry. BMC Rheumatol. 2020 Sep 19;4:46. doi: 10.1186/s41927-020-00145-4. eCollection 2020.

    PubMed 32968710

  • Rahman P, Arendse R, Khraishi M, Sholter D, Sheriff M, Rampakakis E, Lehman AJ, Nantel F. Long-term effectiveness and safety of infliximab, golimumab and ustekinumab in patients with psoriatic arthritis from a Canadian prospective observational registry. BMJ Open. 2020 Aug 13;10(8):e036245. doi: 10.1136/bmjopen-2019-036245.

    PubMed 32792436

  • Rahman P, Zummer M, Bessette L, Baer P, Haraoui B, Chow A, Kelsall J, Kapur S, Rampakakis E, Psaradellis E, Lehman AJ, Nantel F, Osborne B, Tkaczyk C. Real-world validation of the minimal disease activity index in psoriatic arthritis: an analysis from a prospective, observational, biological treatment registry. BMJ Open. 2017 Aug 30;7(8):e016619. doi: 10.1136/bmjopen-2017-016619.

    PubMed 28855200

  • Rahman P, Choquette D, Bensen WG, Khraishi M, Chow A, Zummer M, Shaikh S, Sheriff M, Dixit S, Sholter D, Psaradellis E, Sampalis JS, Letourneau V, Lehman AJ, Nantel F, Rampakakis E, Otawa S, Shawi M. Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis. BMJ Open. 2016 Apr 5;6(4):e009661. doi: 10.1136/bmjopen-2015-009661.

    PubMed 27048632

  • Haraoui B, Jovaisas A, Bensen WG, Faraawi R, Kelsall J, Dixit S, Rodrigues J, Sheriff M, Rampakakis E, Sampalis JS, Lehman AJ, Otawa S, Nantel F, Shawi M. Use of corticosteroids in patients with rheumatoid arthritis treated with infliximab: treatment implications based on a real-world Canadian population. RMD Open. 2015 Apr 29;1(1):e000078. doi: 10.1136/rmdopen-2015-000078. eCollection 2015.

    PubMed 26509071

Questions about this trial

What is this clinical trial studying?

An observational study of Arthritis, Rheumatoid and Spondyloarthritis, Axial, run by Janssen Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Status of Canadian Participants With Rheumatic Disease Treated With Infliximab (time frame: Up to 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00741793, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in