Biologic Treatment Registry Across Canada (BioTRAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00741793

Recruitment Status : Active, not recruiting

First Posted : August 26, 2008

Last Update Posted : March 27, 2018

Sponsor:

Information provided by (Responsible Party):

Janssen Inc.

Study Description

Brief Summary:

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.

Condition or disease
Arthritis, Rheumatoid Spondyloarthritis, Axial Arthritis, Psoriatic

Detailed Description:

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

Study Design


Study Type :	Observational
Estimated Enrollment :	3000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	BioTRAC (BIOLOGIC TREATMENT REGISTRY ACROSS CANADA)
Actual Study Start Date :	February 12, 2002
Estimated Primary Completion Date :	September 17, 2018
Estimated Study Completion Date :	September 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Genetic and Rare Diseases Information Center resources: Spondylarthropathy

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Participants with RA, AxSpA, 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 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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741793

Locations


Canada, Quebec

Montreal, Quebec, Canada

Sponsors and Collaborators

Janssen Inc.

Investigators


Study Director:	Janssen Inc. Clinical Trial	Janssen Inc.

More Information

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

Rahman P, Zummer M, Bessette L, Baer P, Haraoui B, Chow A, Kelsall J, Kapur S, Rampakakis E, Psaradellis E, Lehman AJ, Nantel F, Osborne B, Tkaczyk C. Real-world validation of the minimal disease activity index in psoriatic arthritis: an analysis from a prospective, observational, biological treatment registry. BMJ Open. 2017 Aug 30;7(8):e016619. doi: 10.1136/bmjopen-2017-016619.

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.

Haraoui B, Jovaisas A, Bensen WG, Faraawi R, Kelsall J, Dixit S, Rodrigues J, Sheriff M, Rampakakis E, Sampalis JS, Lehman AJ, Otawa S, Nantel F, Shawi M. Use of corticosteroids in patients with rheumatoid arthritis treated with infliximab: treatment implications based on a real-world Canadian population. RMD Open. 2015 Apr 29;1(1):e000078. doi: 10.1136/rmdopen-2015-000078. eCollection 2015.


Responsible Party:	Janssen Inc.
ClinicalTrials.gov Identifier:	NCT00741793 History of Changes
Other Study ID Numbers:	CR100762 P02843 ( Other Identifier: Janssen Inc. )
First Posted:	August 26, 2008 Key Record Dates
Last Update Posted:	March 27, 2018
Last Verified:	March 2018


Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Janssen Inc.:


Rheumatoid arthritis; psoriatic arthritis; axial spondyloarthritis Remicade® Simponi® Simponi® I.V	Stelara® Registry BioTRAC

Additional relevant MeSH terms:


Arthritis Spondylarthritis Arthritis, Rheumatoid Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylitis Spinal Diseases Bone Diseases	Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Spondylarthropathies Psoriasis Skin Diseases, Papulosquamous Skin Diseases

To Top