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Biologic Rheumatology Registry Across Canada (BioTRAC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Janssen Inc.
Sponsor:
Information provided by (Responsible Party):
Janssen Inc.
ClinicalTrials.gov Identifier:
NCT00741793
First received: August 22, 2008
Last updated: November 5, 2014
Last verified: November 2014
  Purpose

This registry is a multi-center, prospective, observational program that will gather and analyze data on subjects being treated with infliximab and golimumab for rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PsA). In contrast to a controlled clinical trial, there is no imposed experimental intervention and the subjects' physicians solely will determine the subject's treatment. Thus, the data captured and reported in this registry will reflect a "real world" approach to treatment with infliximab or golimumab.


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) Rheumatology (Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis)

Resource links provided by NLM:


Further study details as provided by Janssen Inc.:

Primary Outcome Measures:
  • Disease status of Canadian subjects treated with infliximab or golimumab [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of subjects 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 and golimumab [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

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:

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

  Eligibility

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 or golimumab at the time of enrollment or has been treated with one other prior biologic (including infliximab and golimumab) within the 6 months prior to enrollment
  • Participant has been diagnosed with RA, AS or PsA and is eligible for treatment with infliximab or golimumab as per the Product Monograph

Exclusion Criteria:

  • Participant was treated with any biologic, for any period of time, prior to 6 months 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:
No publications provided

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: November 5, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Janssen Inc.:
Rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis
Remicade®
Simponi®
registry
BioTRAC

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

ClinicalTrials.gov processed this record on November 20, 2014