Investigating the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents
An Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian Rheumatology
1 other identifier
observational
5,000
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 6, 2018
CompletedFirst Posted
Study publicly available on registry
March 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMarch 21, 2018
March 1, 2018
3.3 years
March 6, 2018
March 19, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Disease activity score based on a 28 joint count (DAS28)
Comparative assessment of disease activity as measured by DAS28 in patients receiving originators vs biosimilars. Higher DAS28 scores indicate more severe disease activity.
3 years
Health Assessment Questionnaire Disability Index (HAQ-DI)
Comparative assessment of disease impact on quality of life and daily physical functions in patients receiving originators vs biosimilars. HAQ-DI is designed to measure impact on everyday life. Higher scores indicate more severe disability.
3 years
Secondary Outcomes (4)
36-item Short Form Health Survey (SF-36)
3 years
Patient Health Questionnaire-2 (PHQ-2)
3 years
Fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire
3 years
Number of patients discontinuing the drug for safety reasons
3 years
Study Arms (2)
Originator
Originator anti-TNF agents. Dosage as per physician's decision based on approved indication.
Biosimilar
Biosimilar anti-TNF agents. Dosage as per physician's decision based on approved indication.
Interventions
Originator anti-TNF agents
Biosimilar anti-TNF agents
Eligibility Criteria
Male and female adults (\>= 18 years) with a confirmed diagnosis of RA, PsA, or AS
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Opal Rheumatology Ltd.lead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (22)
Canberra Rheumatology
Canberra, Australian Capital Territory, 2601, Australia
Rheumatology ACT
Canberra, Australian Capital Territory, 2606, Australia
Susan Street Specialists Centre
Camperdown, New South Wales, 2042, Australia
Hills Rheumatology
Castle Hill, New South Wales, 2154, Australia
Orthopaedic and Arthritis Centre
Chatswood, New South Wales, 2067, Australia
Georgetown Arthritis
Georgetown, New South Wales, 2298, Australia
Combined Rheumatology Practice
Kogarah, New South Wales, 2217, Australia
Rheumatology United
Penrith, New South Wales, 2750, Australia
Coast Joint Care
Maroochydore, Queensland, 4558, Australia
Gold Coast Rheumatology
Southport, Queensland, 4215, Australia
Townsville Hospital - Rheumatology
Townsville, Queensland, 4814, Australia
Hobart Specialists Group
Hobart, Tasmania, 7000, Australia
Rheumatology Tasmania
Hobart, Tasmania, 7000, Australia
Southern Rheumatology
Brighton, Victoria, 3186, Australia
Northern Rheumatology and Specialists
Brunswick, Victoria, 3055, Australia
Monash Rheumatology
Clayton, Victoria, 3168, Australia
Coburg Rheumatology
Coburg, Victoria, 3058, Australia
Melbourne Arthritis Associates
Fitzroy, Victoria, 3065, Australia
Footscray Specialist Rooms
Footscray, Victoria, 3011, Australia
Barwon Rheumatology Service
Geelong, Victoria, 3220, Australia
Peninsula Rheumatology
Langwarrin, Victoria, 3220, Australia
Subiaco Rheumatology
Subiaco, Western Australia, 6009, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Bird
Optimus Research
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2018
First Posted
March 20, 2018
Study Start
March 1, 2018
Primary Completion
June 1, 2021
Study Completion
December 31, 2021
Last Updated
March 21, 2018
Record last verified: 2018-03