Biologic Treatment Registry Across Canada (BioTRAC)

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Spondyloarthritis, Axial; Arthritis, Psoriatic; Arthritis, Rheumatoid

Study type: Observational

Funder types: Industry

Identifiers

NCT00741793

CR100762

P02843 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 2,821 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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