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.
Study Type
OBSERVATIONAL
Enrollment
5,000
Originator anti-TNF agents
Biosimilar anti-TNF agents
Canberra Rheumatology
Canberra, Australian Capital Territory, Australia
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.
Time frame: 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.
Time frame: 3 years
36-item Short Form Health Survey (SF-36)
Comparative assessment of disease impact on quality of life in patients receiving originators vs biosimilars. The SF-36 uses 8 sub scales to assess patient vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Each sub scale is scored between 0-100, where lower scores indicate a greater impact on function.
Time frame: 3 years
Patient Health Questionnaire-2 (PHQ-2)
Comparative assessment of disease impact on the emotional health in patients receiving originators vs biosimilars, as measured by the PHQ-2. The PHQ-2 is a two-question survey to screen for depression, and higher scores indicate that the patient experienced depressed mood or anhedonia more frequently over the past two weeks.
Time frame: 3 years
Fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire
Comparative assessment of fatigue in patients receiving originators vs biosimilars, assessed using the FACIT-fatigue scale. FACIT-fatigue is a questionnaire used to measure fatigue levels in patients with rheumatoid arthritis. A higher score is associated with a greater level of fatigue.
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Rheumatology ACT
Canberra, Australian Capital Territory, Australia
RECRUITINGSusan Street Specialists Centre
Camperdown, New South Wales, Australia
RECRUITINGHills Rheumatology
Castle Hill, New South Wales, Australia
RECRUITINGOrthopaedic and Arthritis Centre
Chatswood, New South Wales, Australia
RECRUITINGGeorgetown Arthritis
Georgetown, New South Wales, Australia
RECRUITINGCombined Rheumatology Practice
Kogarah, New South Wales, Australia
RECRUITINGRheumatology United
Penrith, New South Wales, Australia
RECRUITINGCoast Joint Care
Maroochydore, Queensland, Australia
RECRUITINGGold Coast Rheumatology
Southport, Queensland, Australia
RECRUITING...and 12 more locations
Time frame: 3 years
Number of patients discontinuing the drug for safety reasons
Comparison between number of patients using originator vs biosimilar who discontinue therapy for safety reasons.
Time frame: 3 years