Biologic Treatment Registry Across Canada

Completed

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

• Registration Number: NCT00741793
• Lead Sponsor: Janssen Inc.

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.

Study Timeline

• Study Start: 2002-02-12
• Study First Submitted: 2008-08-22
• Study First Submitted QC: 2008-08-22
• Study First Posted: 2008-08-26
• Primary Completion: 2018-06-27
• Study Completion: 2018-06-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2821

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease Status of Canadian Participants With Rheumatic Disease Treated With Golimumab	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)	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	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 Infliximab	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.

Secondary Outcome Measures

Name	Time	Method
Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Golimumab	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 Infliximab	Up to 4 years	Provides expanded data to health care providers and hospitals to estimate and support appropriate use of Infliximab.
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 Golimumab I.V	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	Up to 4 years	Provides expanded data to health care providers and hospitals to estimate and support appropriate use of Ustekinumab.