Investigating the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents
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|ClinicalTrials.gov Identifier: NCT03470688|
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : March 20, 2018
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis||Biological: Originator Biological: Biosimilar|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||5000 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||An Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian Rheumatology|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Originator anti-TNF agents. Dosage as per physician's decision based on approved indication.
Originator anti-TNF agents
Biosimilar anti-TNF agents. Dosage as per physician's decision based on approved indication.
Biosimilar anti-TNF agents
- Disease activity score based on a 28 joint count (DAS28) [ Time Frame: 3 years ]Comparative assessment of disease activity as measured by DAS28 in patients receiving originators vs biosimilars. Higher DAS28 scores indicate more severe disease activity.
- Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: 3 years ]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.
- 36-item Short Form Health Survey (SF-36) [ Time Frame: 3 years ]
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.
- Patient Health Questionnaire-2 (PHQ-2) [ Time Frame: 3 years ]
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.
- Fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire [ Time Frame: 3 years ]
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.
- Number of patients discontinuing the drug for safety reasons [ Time Frame: 3 years ]Comparison between number of patients using originator vs biosimilar who discontinue therapy for safety reasons.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470688
|Contact: Tegan Smithfirstname.lastname@example.org|
|Australia, Australian Capital Territory|
|Canberra, Australian Capital Territory, Australia, 2601|
|Canberra, Australian Capital Territory, Australia, 2606|
|Australia, New South Wales|
|Susan Street Specialists Centre||Recruiting|
|Camperdown, New South Wales, Australia, 2042|
|Castle Hill, New South Wales, Australia, 2154|
|Orthopaedic and Arthritis Centre||Recruiting|
|Chatswood, New South Wales, Australia, 2067|
|Georgetown, New South Wales, Australia, 2298|
|Combined Rheumatology Practice||Recruiting|
|Kogarah, New South Wales, Australia, 2217|
|Penrith, New South Wales, Australia, 2750|
|Coast Joint Care||Recruiting|
|Maroochydore, Queensland, Australia, 4558|
|Gold Coast Rheumatology||Recruiting|
|Southport, Queensland, Australia, 4215|
|Townsville Hospital - Rheumatology||Recruiting|
|Townsville, Queensland, Australia, 4814|
|Hobart Specialists Group||Recruiting|
|Hobart, Tasmania, Australia, 7000|
|Hobart, Tasmania, Australia, 7000|
|Brighton, Victoria, Australia, 3186|
|Northern Rheumatology and Specialists||Recruiting|
|Brunswick, Victoria, Australia, 3055|
|Clayton, Victoria, Australia, 3168|
|Coburg, Victoria, Australia, 3058|
|Melbourne Arthritis Associates||Recruiting|
|Fitzroy, Victoria, Australia, 3065|
|Footscray Specialist Rooms||Recruiting|
|Footscray, Victoria, Australia, 3011|
|Barwon Rheumatology Service||Recruiting|
|Geelong, Victoria, Australia, 3220|
|Langwarrin, Victoria, Australia, 3220|
|Australia, Western Australia|
|Subiaco, Western Australia, Australia, 6009|
|Principal Investigator:||Paul Bird||Optimus Research|