Clinical trial NCT00741793: Biologic Treatment Registry Across Canada
Official title: BioTRAC (BIOLOGIC TREATMENT REGISTRY ACROSS CANADA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Spondyloarthritis, Axial
Arthritis, Psoriatic
Keywords: Rheumatoid arthritis; psoriatic arthritis; axial spondyloarthritis
Remicade®
Simponi®
Simponi® I.V
Stelara®
Registry
BioTRAC
Lead sponsor: Janssen Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 2821
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with RA, AxSpA, or PsA will be selected primarily from community centers and some academic centers.

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.

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

Eligibility 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

Primary outcomes:
measure: Disease Status of Canadian Participants With Rheumatic Disease Treated With Infliximab
timeFrame: Up to 4 years
measure: Disease Status of Canadian Participants With Rheumatic Disease Treated With Golimumab
timeFrame: Up to 4 years
measure: Disease Status of Canadian Participants With Rheumatic Disease Treated With Golimumab Intravenous (I.V)
timeFrame: Up to 4 years
measure: Disease Status of Canadian Participants With Rheumatic Disease Treated With Ustekinumab
timeFrame: Up to 4 years
Secondary outcomes:
measure: The Number of Participants With Adverse Events
timeFrame: Up to 4 years
measure: Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Infliximab
timeFrame: Up to 4 years
measure: Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Golimumab
timeFrame: Up to 4 years
measure: Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Golimumab I.V
timeFrame: Up to 4 years
measure: Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Ustekinumab
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Janssen Inc.
name: Janssen Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Rahman P, Starr M, Haaland D, Bessette L, Teo M, Rampakakis E, Lehman AJ, Nantel F. Long-term effectiveness and safety of infliximab and golimumab in ankylosing spondylitis patients from a Canadian prospective observational registry. BMC Rheumatol. 2020 Nov 15;4(1):56. doi: 10.1186/s41927-020-00158-z.
citation: Rahman P, Baer P, Keystone E, Choquette D, Thorne C, Haraoui B, Chow A, Faraawi R, Olszynski W, Kelsall J, Rampakakis E, Lehman AJ, Nantel F. Long-term effectiveness and safety of infliximab, golimumab and golimumab-IV in rheumatoid arthritis patients from a Canadian prospective observational registry. BMC Rheumatol. 2020 Sep 19;4:46. doi: 10.1186/s41927-020-00145-4. eCollection 2020.
citation: Rahman P, Arendse R, Khraishi M, Sholter D, Sheriff M, Rampakakis E, Lehman AJ, Nantel F. Long-term effectiveness and safety of infliximab, golimumab and ustekinumab in patients with psoriatic arthritis from a Canadian prospective observational registry. BMJ Open. 2020 Aug 13;10(8):e036245. doi: 10.1136/bmjopen-2019-036245.
citation: 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.
citation: 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.
citation: 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.