Clinical trial NCT03470688: Investigating the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents
Official title: An Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian Rheumatology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Lead sponsor: Opal Rheumatology Ltd.
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2018-03-20
Enrollment: 5000
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: Male and female adults (\>= 18 years) with a confirmed diagnosis of RA, PsA, or AS

Brief summary: An observational study investigating the utilisation and effectiveness of originator and biosimilar anti-TNF agents in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.


Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) who are being treated at a participating OPAL clinic.

Exclusion Criteria:

-

Primary outcomes:
measure: Disease activity score based on a 28 joint count (DAS28)
timeFrame: 3 years
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: 3 years
Secondary outcomes:
measure: 36-item Short Form Health Survey (SF-36)
timeFrame: 3 years
measure: Patient Health Questionnaire-2 (PHQ-2)
timeFrame: 3 years
measure: Fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire
timeFrame: 3 years
measure: Number of patients discontinuing the drug for safety reasons
timeFrame: 3 years
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: Canberra Rheumatology
state: Australian Capital Territory
city: Canberra
country: Australia
facility: Rheumatology ACT
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: Susan Street Specialists Centre
state: New South Wales
city: Castle Hill
country: Australia
facility: Hills Rheumatology
state: New South Wales
city: Chatswood
country: Australia
facility: Orthopaedic and Arthritis Centre
state: New South Wales
city: Georgetown
country: Australia
facility: Georgetown Arthritis
state: New South Wales
city: Kogarah
country: Australia
facility: Combined Rheumatology Practice
state: New South Wales
city: Penrith
country: Australia
facility: Rheumatology United
state: New South Wales
city: Maroochydore
country: Australia
facility: Coast Joint Care
state: Queensland
city: Southport
country: Australia
facility: Gold Coast Rheumatology
state: Queensland
city: Townsville
country: Australia
facility: Townsville Hospital - Rheumatology
state: Queensland
city: Hobart
country: Australia
facility: Hobart Specialists Group
state: Tasmania
city: Hobart
country: Australia
facility: Rheumatology Tasmania
state: Tasmania
city: Brighton
country: Australia
facility: Southern Rheumatology
state: Victoria
city: Brunswick
country: Australia
facility: Northern Rheumatology and Specialists
state: Victoria
city: Clayton
country: Australia
facility: Monash Rheumatology
state: Victoria
city: Coburg
country: Australia
facility: Coburg Rheumatology
state: Victoria
city: Fitzroy
country: Australia
facility: Melbourne Arthritis Associates
state: Victoria
city: Footscray
country: Australia
facility: Footscray Specialist Rooms
state: Victoria
city: Geelong
country: Australia
facility: Barwon Rheumatology Service
state: Victoria
city: Langwarrin
country: Australia
facility: Peninsula Rheumatology
state: Victoria
city: Subiaco
country: Australia
facility: Subiaco Rheumatology
state: Western Australia
Study officials:
affiliation: Optimus Research
name: Paul Bird
role: PRINCIPAL_INVESTIGATOR
References: