Biologic Treatment Registry Across Canada

Arthritis, Rheumatoid Clinical Trial

— BioTRAC  

Official title:

BioTRAC (BIOLOGIC TREATMENT REGISTRY ACROSS CANADA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741793
• Other study ID #: CR100762
• Secondary ID: P02843
• Status: Completed
• Start date: February 12, 2002
• Est. completion date: June 29, 2018

Study information

• Verified date: September 2019
• Source: Janssen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2821
• Est. completion date: June 29, 2018
• Est. primary completion date: June 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Spondylarthritis
• Spondyloarthritis, Axial

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	The Number of Participants With Adverse Events		Up to 4 years
Secondary	Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Infliximab	Provides expanded data to health care providers and hospitals to estimate and support appropriate use of Infliximab.	Up to 4 years
Secondary	Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Golimumab	Provides expanded data to health care providers and hospitals to estimate and support appropriate use of Golimumab.	Up to 4 years
Secondary	Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Golimumab I.V	Provides expanded data to health care providers and hospitals to estimate and support appropriate use of Golimumab I.V.	Up to 4 years
Secondary	Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Ustekinumab	Provides expanded data to health care providers and hospitals to estimate and support appropriate use of Ustekinumab.	Up to 4 years