Biologic Treatment Registry Across Canada (BioTRAC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Janssen Inc.
Sponsor:
Information provided by (Responsible Party):
Janssen Inc.
ClinicalTrials.gov Identifier:
NCT00741793
First received: August 22, 2008
Last updated: May 4, 2016
Last verified: May 2016
  Purpose
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.

Condition Phase
Arthritis, Rheumatoid
Spondylitis, Ankylosing
Arthritis, Psoriatic
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: BioTRAC (BIOLOGIC TREATMENT REGISTRY ACROSS CANADA)

Resource links provided by NLM:


Further study details as provided by Janssen Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 3000
Study Start Date: October 2010
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Detailed Description:
Participants will be selected for this registry using a non-probability sampling method.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with RA, AS, or PsA will be selected primarily from community centers and some academic centers.
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741793

Contacts
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

Locations
Canada, Quebec
Recruiting
Montreal, Quebec, Canada
Sponsors and Collaborators
Janssen Inc.
Investigators
Study Director: Janssen Inc. Clinical Trial Janssen Inc.
  More Information

Additional Information:
Responsible Party: Janssen Inc.
ClinicalTrials.gov Identifier: NCT00741793     History of Changes
Other Study ID Numbers: CR100762  P02843 
Study First Received: August 22, 2008
Last Updated: May 4, 2016
Health Authority: Canada: Ethics Review Committee

Keywords provided by Janssen Inc.:
Rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis
Remicade®
Simponi®
Simponi® I.V
Stelara®
Registry
BioTRAC

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthropathies
Spondylarthritis
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ankylosis

ClinicalTrials.gov processed this record on July 25, 2016