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Biologic Treatment Registry Across Canada (BioTRAC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Janssen Inc.
Sponsor:
Information provided by (Responsible Party):
Janssen Inc.
ClinicalTrials.gov Identifier:
NCT00741793
First received: August 22, 2008
Last updated: April 20, 2017
Last verified: April 2017

August 22, 2008
April 20, 2017
February 12, 2002
April 30, 2018   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • 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.
  • 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.
To follow up on efficacy parameters in Canadian subjects treated with Remicade®. [ Time Frame: From baseline, evaluations are conducted every 6 months. ]
Complete list of historical versions of study NCT00741793 on ClinicalTrials.gov Archive Site
  • The Number of Participants With Adverse Events [ Time Frame: 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.
  • 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.
  • 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.
  • 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.
  • To follow up on safety parameters in Canadian subjects treated with Remicade®. [ Time Frame: From baseline, evaluations are conducted every 6 months. ]
  • To provide expanded data to healthcare providers and hospitals to estimate and support appropriate use of Remicade. [ Time Frame: 2-4 times a year ]
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Biologic Treatment Registry Across Canada
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.
Participants will be selected for this registry using a non-probability sampling method.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Participants with RA, AxSpA, or PsA will be selected primarily from community centers and some academic centers.
  • Arthritis, Rheumatoid
  • Spondyloarthritis, Axial
  • Arthritis, Psoriatic
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
December 31, 2020
April 30, 2018   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com
Canada
 
 
NCT00741793
CR100762
P02843 ( Other Identifier: Janssen Inc. )
No
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Janssen Inc.
Janssen Inc.
Not Provided
Study Director: Janssen Inc. Clinical Trial Janssen Inc.
Janssen Inc.
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP