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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03470688
Registration number
NCT03470688
Ethics application status
Date submitted
6/03/2018
Date registered
20/03/2018
Date last updated
21/03/2018
Titles & IDs
Public title
Investigating the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents
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Scientific title
An Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian Rheumatology
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Secondary ID [1]
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MSD biosimilars
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Psoriatic Arthritis
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Ankylosing Spondylitis
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Other - Originator
Treatment: Other - Biosimilar
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.
Treatment: Other: Originator
Originator anti-TNF agents
Treatment: Other: Biosimilar
Biosimilar anti-TNF agents
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease activity score based on a 28 joint count (DAS28)
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Assessment method [1]
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Comparative assessment of disease activity as measured by DAS28 in patients receiving originators vs biosimilars. Higher DAS28 scores indicate more severe disease activity.
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Timepoint [1]
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3 years
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Primary outcome [2]
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Health Assessment Questionnaire Disability Index (HAQ-DI)
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Assessment method [2]
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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.
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Timepoint [2]
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3 years
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Secondary outcome [1]
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36-item Short Form Health Survey (SF-36)
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Assessment method [1]
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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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Timepoint [1]
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3 years
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Secondary outcome [2]
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Patient Health Questionnaire-2 (PHQ-2)
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Assessment method [2]
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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.
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Timepoint [2]
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3 years
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Secondary outcome [3]
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Fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire
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Assessment method [3]
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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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Timepoint [3]
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3 years
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Secondary outcome [4]
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Number of patients discontinuing the drug for safety reasons
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Assessment method [4]
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Comparison between number of patients using originator vs biosimilar who discontinue therapy for safety reasons.
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Timepoint [4]
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3 years
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
-
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2021
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Actual
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Sample size
Target
5000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC,WA
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Recruitment hospital [1]
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Canberra Rheumatology - Canberra
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Recruitment hospital [2]
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Rheumatology ACT - Canberra
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Recruitment hospital [3]
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Susan Street Specialists Centre - Camperdown
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Recruitment hospital [4]
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Hills Rheumatology - Castle Hill
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Recruitment hospital [5]
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Orthopaedic and Arthritis Centre - Chatswood
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Recruitment hospital [6]
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Georgetown Arthritis - Georgetown
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Recruitment hospital [7]
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Combined Rheumatology Practice - Kogarah
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Recruitment hospital [8]
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Rheumatology United - Penrith
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Recruitment hospital [9]
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Coast Joint Care - Maroochydore
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Recruitment hospital [10]
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Gold Coast Rheumatology - Southport
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Recruitment hospital [11]
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Townsville Hospital - Rheumatology - Townsville
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Recruitment hospital [12]
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Hobart Specialists Group - Hobart
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Recruitment hospital [13]
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Rheumatology Tasmania - Hobart
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Recruitment hospital [14]
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Southern Rheumatology - Brighton
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Recruitment hospital [15]
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Northern Rheumatology and Specialists - Brunswick
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Recruitment hospital [16]
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Monash Rheumatology - Clayton
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Recruitment hospital [17]
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Coburg Rheumatology - Coburg
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Recruitment hospital [18]
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Melbourne Arthritis Associates - Fitzroy
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Recruitment hospital [19]
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Footscray Specialist Rooms - Footscray
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Recruitment hospital [20]
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Barwon Rheumatology Service - Geelong
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Recruitment hospital [21]
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Peninsula Rheumatology - Langwarrin
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Recruitment hospital [22]
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Subiaco Rheumatology - Subiaco
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Recruitment postcode(s) [1]
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2601 - Canberra
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Recruitment postcode(s) [2]
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2606 - Canberra
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Recruitment postcode(s) [3]
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2042 - Camperdown
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Recruitment postcode(s) [4]
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2154 - Castle Hill
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Recruitment postcode(s) [5]
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2067 - Chatswood
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Recruitment postcode(s) [6]
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2298 - Georgetown
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Recruitment postcode(s) [7]
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2217 - Kogarah
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Recruitment postcode(s) [8]
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2750 - Penrith
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Recruitment postcode(s) [9]
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4558 - Maroochydore
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Recruitment postcode(s) [10]
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4215 - Southport
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Recruitment postcode(s) [11]
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4814 - Townsville
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Recruitment postcode(s) [12]
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7000 - Hobart
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Recruitment postcode(s) [13]
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3186 - Brighton
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Recruitment postcode(s) [14]
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3055 - Brunswick
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Recruitment postcode(s) [15]
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3168 - Clayton
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Recruitment postcode(s) [16]
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3058 - Coburg
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Recruitment postcode(s) [17]
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3065 - Fitzroy
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Recruitment postcode(s) [18]
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3011 - Footscray
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Recruitment postcode(s) [19]
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3220 - Geelong
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Recruitment postcode(s) [20]
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3220 - Langwarrin
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Recruitment postcode(s) [21]
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6009 - Subiaco
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Funding & Sponsors
Primary sponsor type
Other
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Name
Opal Rheumatology Ltd.
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Merck Sharp & Dohme LLC
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT03470688
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Paul Bird
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Address
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Optimus Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Tegan Smith
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Address
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Country
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Phone
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+61280706805
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03470688
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