Biologic Treatment Registry Across Canada - Full Text View

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:

MedlinePlus related topics: Ankylosing Spondylitis Arthritis Psoriatic Arthritis Rheumatoid Arthritis

Genetic and Rare Diseases Information Center resources: Spondylarthropathy

U.S. FDA Resources

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:

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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:	August 17, 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 Spondylitis Arthritis, Rheumatoid Arthritis, Psoriatic 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 September 23, 2016