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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03470688 |
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Date of registration:
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06/03/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Investigating the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents
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Scientific title:
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An Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian Rheumatology |
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Date of first enrolment:
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March 1, 2018 |
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Target sample size:
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5000 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03470688 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Australia
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Contacts
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Name:
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Tegan Smith |
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Address:
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Telephone:
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+61280706805 |
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Email:
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info@opalrheumatology.com.au |
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Affiliation:
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Name:
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Paul Bird |
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Address:
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Telephone:
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Email:
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Affiliation:
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Optimus Research |
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Key inclusion & exclusion criteria
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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.
Exclusion Criteria:
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Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Rheumatoid Arthritis
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Psoriatic Arthritis
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Intervention(s)
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Biological: Biosimilar
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Biological: Originator
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Primary Outcome(s)
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Health Assessment Questionnaire Disability Index (HAQ-DI)
[Time Frame: 3 years]
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Disease activity score based on a 28 joint count (DAS28)
[Time Frame: 3 years]
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Secondary Outcome(s)
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Number of patients discontinuing the drug for safety reasons
[Time Frame: 3 years]
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36-item Short Form Health Survey (SF-36)
[Time Frame: 3 years]
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Patient Health Questionnaire-2 (PHQ-2)
[Time Frame: 3 years]
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Fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire
[Time Frame: 3 years]
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Secondary ID(s)
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MSD biosimilars
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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