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Biologic Treatment Registry Across Canada (BioTRAC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Janssen Inc.
Sponsor:
Information provided by (Responsible Party):
Janssen Inc.
ClinicalTrials.gov Identifier:
NCT00741793
First received: August 22, 2008
Last updated: August 17, 2016
Last verified: August 2016

August 22, 2008
August 17, 2016
October 2010
April 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Infliximab [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
  • To provide expanded data to healthcare providers and hospitals to estimate and support appropriate use of Remicade. [ Time Frame: 2-4 times a year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA); there will be no randomized assignments to treatment. At enrollment 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, AS and PsA.
Participants will be selected for this registry using a non-probability sampling method.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Participants with RA, AS, or PsA will be selected primarily from community centers and some academic centers.
  • Arthritis, Rheumatoid
  • Spondylitis, Ankylosing
  • Arthritis, Psoriatic
Not Provided
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
April 2018
April 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 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, AS 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

Both
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
No
Not Provided
Not Provided
Janssen Inc.
Janssen Inc.
Not Provided
Study Director: Janssen Inc. Clinical Trial Janssen Inc.
Janssen Inc.
August 2016

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