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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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30 May 2022 |
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Main ID: |
NCT03138941 |
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Date of registration:
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01/05/2017 |
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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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Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region
APLCLLDAS |
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Scientific title:
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Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region |
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Date of first enrolment:
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September 1, 2013 |
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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/NCT03138941 |
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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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China
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Hong Kong
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India
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Indonesia
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Japan
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Korea, Republic of
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Malaysia
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Philippines
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Singapore
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Sri Lanka
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Taiwan
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Thailand
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United Arab Emirates
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Contacts
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Name:
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Eric F Morand |
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Address:
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Telephone:
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+ 61 3 8572 2650 |
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Email:
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eric.morand@monash.edu |
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Affiliation:
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Name:
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Eric Morand |
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Address:
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Telephone:
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Email:
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Affiliation:
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Monash University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients have to meet either the 1997 American College of Rheumatology (ACR)
Modified Classification Criteria for SLE, with at least four of the 11 items; or
alternatively, fulfil the Systemic Lupus International Collaborating Clinics (SLICC)
2012 Classification Criteria, with at least four of the 17 items (at least one
clinical and one immunological criterion) or with lupus nephritis in the presence of
at least one immunological criteria. Patients can be either newly diagnosed or
longstanding lupus patients.
All patients must be over the age of 18 and competent to provide written consent.
Exclusion Criteria:
- Patients less than 18 years of age and patients who are unable to consent are excluded
from the study.
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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Systemic Lupus Erythematosus
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Primary Outcome(s)
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SLICC-ACR Damage Index
[Time Frame: Approximately 5-10 years]
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Secondary Outcome(s)
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SFv2-36
[Time Frame: Approximately 5-10 years]
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Mortality
[Time Frame: Approximately 5-10 years]
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Secondary ID(s)
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APLC LLDAS Study
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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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