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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Originator | Biological | Originator anti-TNF agents |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female adults (>= 18 years) with a confirmed diagnosis of RA, PsA, or AS
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tegan Smith | Contact | +61280706805 | info@opalrheumatology.com.au |
| Name | Affiliation | Role |
|---|---|---|
| Paul Bird | Optimus Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canberra Rheumatology | Recruiting | Canberra | Australian Capital Territory | 2601 | Australia | |
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| Biosimilar | Biological | Biosimilar anti-TNF agents |
|
|
| 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. | 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. | 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. | 3 years |
| Rheumatology ACT |
| Recruiting |
| Canberra |
| Australian Capital Territory |
| 2606 |
| Australia |
| Susan Street Specialists Centre | Recruiting | Camperdown | New South Wales | 2042 | Australia |
| Hills Rheumatology | Recruiting | Castle Hill | New South Wales | 2154 | Australia |
| Orthopaedic and Arthritis Centre | Recruiting | Chatswood | New South Wales | 2067 | Australia |
| Georgetown Arthritis | Recruiting | Georgetown | New South Wales | 2298 | Australia |
| Combined Rheumatology Practice | Recruiting | Kogarah | New South Wales | 2217 | Australia |
| Rheumatology United | Recruiting | Penrith | New South Wales | 2750 | Australia |
| Coast Joint Care | Recruiting | Maroochydore | Queensland | 4558 | Australia |
| Gold Coast Rheumatology | Recruiting | Southport | Queensland | 4215 | Australia |
| Townsville Hospital - Rheumatology | Recruiting | Townsville | Queensland | 4814 | Australia |
| Hobart Specialists Group | Recruiting | Hobart | Tasmania | 7000 | Australia |
| Rheumatology Tasmania | Recruiting | Hobart | Tasmania | 7000 | Australia |
| Southern Rheumatology | Recruiting | Brighton | Victoria | 3186 | Australia |
| Northern Rheumatology and Specialists | Recruiting | Brunswick | Victoria | 3055 | Australia |
| Monash Rheumatology | Recruiting | Clayton | Victoria | 3168 | Australia |
| Coburg Rheumatology | Recruiting | Coburg | Victoria | 3058 | Australia |
| Melbourne Arthritis Associates | Recruiting | Fitzroy | Victoria | 3065 | Australia |
| Footscray Specialist Rooms | Recruiting | Footscray | Victoria | 3011 | Australia |
| Barwon Rheumatology Service | Recruiting | Geelong | Victoria | 3220 | Australia |
| Peninsula Rheumatology | Recruiting | Langwarrin | Victoria | 3220 | Australia |
| Subiaco Rheumatology | Recruiting | Subiaco | Western Australia | 6009 | Australia |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D000089183 | Axial Spondyloarthritis |
| D000844 | Ankylosis |
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| ID | Term |
|---|---|
| C437337 | MIDORI protein, mouse |
| D000068800 | Etanercept |
| D059451 | Biosimilar Pharmaceuticals |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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