Biologic Treatment Registry Across Canada

NCT00741793 | Completed

• 2 other identifiers: CR100762P02843
• Study Type: observational
• Target: 2,821
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Rheumatoid; Spondyloarthritis, Axial; Arthritis, Psoriatic

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Disease Status of Canadian Participants With Rheumatic Disease Treated With Infliximab

  Physician will rate arthritis activity using Visual Analog Scale (VAS) ranging from 0 to 100; higher scores indicated greater affectation due to disease activity.

  Up to 4 years

• Disease Status of Canadian Participants With Rheumatic Disease Treated With Golimumab

  Physician will rate arthritis activity using VAS ranging from 0 to 100; higher scores indicated greater affectation due to disease activity.

  Up to 4 years

• Disease Status of Canadian Participants With Rheumatic Disease Treated With Golimumab Intravenous (I.V)

  Physician will rate arthritis activity using VAS ranging from 0 to 100; higher scores indicated greater affectation due to disease activity.

  Up to 4 years

• Disease Status of Canadian Participants With Rheumatic Disease Treated With Ustekinumab

  Physician will rate arthritis activity using VAS ranging from 0 to 100; higher scores indicated greater affectation due to disease activity.

  Up to 4 years

Secondary Outcomes (5)

• The Number of Participants With Adverse Events

  Up to 4 years

• Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Infliximab

  Up to 4 years

• Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Golimumab

  Up to 4 years

• Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Golimumab I.V

  Up to 4 years

• Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Ustekinumab

  Up to 4 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with RA, AxSpA, or PsA will be selected primarily from community centers and some academic centers.

You may qualify if:

• 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.

You may not qualify if:

• \- Participant was treated with two or more biologics, for any period of time before enrollment

Sponsors & Collaborators

• Janssen Inc.: lead

Study Sites (1)

Unknown Facility

Montreal, Quebec, Canada

Location

Related Publications (8)

• Arendse R, Rahman P, Baer P, Haaland D, Bessette L, Sholter D, Rachich M, Rampakakis E, Marrache AM, Lehman AJ, Asin-Milan O. Safety of Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Axial Spondyloarthritis: Results from a Real-World Canadian Setting. Rheumatol Ther. 2025 Dec;12(6):1043-1055. doi: 10.1007/s40744-025-00788-0. Epub 2025 Sep 19.

  PMID: 40971024 DERIVED

• Bessette L, Rahman P, Kelsall J, Purvis J, Rampakakis E, Lehman AJ, Rachich M, Nantel F, Asin-Milan O, Marrache AM. Real-World Incidence and Determinants of Infection in Patients With Rheumatoid Arthritis Treated With Golimumab After a Median Follow-Up Time of 27 Months. J Rheumatol. 2023 Sep;50(9):1121-1126. doi: 10.3899/jrheum.2022-1283. Epub 2023 Jun 1.

  PMID: 37263649 DERIVED

• 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.

  PMID: 33292797 DERIVED

• 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.

  PMID: 32968710 DERIVED

• 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.

  PMID: 32792436 DERIVED

• 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.

  PMID: 28855200 DERIVED

• 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.

  PMID: 27048632 DERIVED

• 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.

  PMID: 26509071 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Axial Spondyloarthritis; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Officials

• Janssen Inc. Clinical Trial

  Janssen Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2008
• First Posted: August 26, 2008
• Study Start: February 12, 2002
• Primary Completion: June 27, 2018
• Study Completion: June 29, 2018
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

CA (1)