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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03138941
Registration number
NCT03138941
Ethics application status
Date submitted
1/05/2017
Date registered
3/05/2017
Titles & IDs
Public title
Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region
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Scientific title
Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region
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Secondary ID [1]
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APLC LLDAS Study
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Universal Trial Number (UTN)
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Trial acronym
APLCLLDAS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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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
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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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SLICC-ACR Damage Index
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Assessment method [1]
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Organ damage accrual
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Timepoint [1]
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Approximately 5-10 years
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Secondary outcome [1]
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SFv2-36
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Assessment method [1]
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Quality of Life
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Timepoint [1]
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Approximately 5-10 years
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Secondary outcome [2]
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Mortality
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Assessment method [2]
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Mortality
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Timepoint [2]
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Approximately 5-10 years
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Eligibility
Key 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.
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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
* Patients less than 18 years of age and patients who are unable to consent are excluded from the study.
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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
Recruiting
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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
1/09/2013
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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
31/12/2032
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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)
SA,VIC
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Recruitment hospital [1]
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Rheumatology Unit, Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Department of Rheumatology, Flinders Medical Centre - Adelaide
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Recruitment hospital [3]
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School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing & Health Sciences - Clayton
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Recruitment hospital [4]
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Department of Rheumatology, St Vincent's Hospital (Melbourne) - Fitzroy
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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5042 - Adelaide
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3065 - Fitzroy
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Western District
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Country [2]
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China
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State/province [2]
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Xicheng District
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Country [3]
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Hong Kong
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State/province [3]
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Pok Fu Lam
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Country [4]
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Indonesia
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State/province [4]
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West Java
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Country [5]
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Japan
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State/province [5]
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Kitakyushu
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Country [6]
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Japan
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State/province [6]
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Tokyo
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Country [7]
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Korea, Republic of
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State/province [7]
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Seoul
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Philippines
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State/province [8]
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Manila
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Philippines
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State/province [9]
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Quezon City
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Singapore
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State/province [10]
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Singapore
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Country [11]
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Singapore
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State/province [11]
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Tan Tock Seng
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Country [12]
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Sri Lanka
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State/province [12]
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Kandy
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Country [13]
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Taiwan
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State/province [13]
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Taoyuan County
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Country [14]
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Taiwan
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State/province [14]
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Taichung
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Country [15]
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Thailand
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State/province [15]
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Muang District
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Flinders Medical Centre, Adelaide, AUSTRALIA
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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St. Vincent's Hospital, Melbourne, AUSTRALIA
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Royal Adelaide Hospital, Adelaide, AUSTRALIA
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Address [3]
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Other
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University of New South Wales, Sydney, AUSTRALIA
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Other
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People's Hospital, Peking University Health Science Center, Beijing, CHINA
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Other collaborator category [6]
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Other
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Peking University First Hospital, Beijing, CHINA
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Other collaborator category [7]
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Other
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The University of Hong Kong, HONG KONG
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Address [7]
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Other
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University of Padjadjaran, Bandung, INDONESIA
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Other collaborator category [9]
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Other
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Tokyo Women's Medical University, JAPAN
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Other
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University of Occupational and Environmental Health, JAPAN
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Other
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Keio University, JAPAN
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Other collaborator category [12]
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Other
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Hanyang University Hospital for Rheumatic Diseases, REPUBLIC OF KOREA
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Address [12]
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Other collaborator category [13]
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Other
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Name [13]
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University of Santo Tomas Hospital, Philippines
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Other
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National University Hospital, Singapore
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Other
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Tan Tock Seng Hospital
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Other collaborator category [16]
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Other
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Name [16]
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Chang Gung Memorial Hospital
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Other
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Taichung Veterans General Hospital
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Other
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Name [18]
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Chiang Mai University Hospital, THAILAND
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Address [18]
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Other collaborator category [19]
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Other
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Name [19]
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Middlemore Hospital, New Zealand
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Address [19]
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Other collaborator category [20]
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Other
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Name [20]
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North Shore Hospital, Auckland, NEW ZEALAND
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Address [20]
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Other collaborator category [21]
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Other
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Name [21]
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Auckland District Health Board, Auckland, NEW ZEALAND
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Address [21]
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Other collaborator category [22]
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Other
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Name [22]
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Teaching Hospital Kandy, SRI LANKA
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Address [22]
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Other collaborator category [23]
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Other
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Name [23]
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University of the Philippines, Philippines
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Address [23]
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Ethics approval
Ethics application status
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Summary
Brief summary
Lupus Low Disease Activity State (LLDAS) study is an international, multi-centre prospective study, developed by the Asia Pacific Lupus Collaboration (APLC) to investigate whether the attainment of LLDAS is associated with improved outcomes in patients with Systemic Lupus Erythematosus (SLE). SLE, or lupus, is the archetypal multisystem autoimmune disease, with an estimated incidence of 5-50 cases per 100,000 people. Patients with SLE, usually young women, suffer a marked loss of life expectancy, and severe morbidity, due to a heterogeneous range of clinical manifestations caused by autoimmune-mediated inflammation of multiple organs. The most severe manifestations of SLE are the accrual of irreversible organ damage, especially renal and central nervous system (CNS) involvement. As there is no effective targeted monotherapy for SLE, patients also suffer severe toxicity from the use of glucocorticoids and broad-spectrum immunosuppressive therapies. Despite combination therapy with current drugs, many studies show that the majority of patients suffer inadequate disease control and inexorably accrue permanent organ damage over time. The diversity of clinical features of active SLE has made quantification of disease activity problematic. Although there are a number of published systems in use to measure SLE disease activity, there are widely acknowledged problems with these instruments. Published definitions of remission are so stringent that they are met by less than 5% of patients. This lead to the realisation that rather than lupus remission, a lupus low disease activity state target may be more feasible, and that patients with low disease activity are more homogeneous than patients with active disease. Thus, the development of a definition of lupus low disease activity, which is feasible and has face validity, escapes the complexity of attempts to quantify heterogeneous states of active disease. In this study, the investigators will prospectively collect longitudinal data on consecutive SLE patients at each centre to evaluate the LLDAS definition. Protection from organ damage accrual as the primary endpoint.
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Trial website
https://clinicaltrials.gov/study/NCT03138941
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Trial related presentations / publications
Golder V, Huq M, Franklyn K, Calderone A, Lateef A, Lau CS, Lee ALH, Navarra STV, Godfrey T, Oon S, Hoi AYB, Morand EF, Nikpour M. Does expert opinion match the operational definition of the Lupus Low Disease Activity State (LLDAS)? A case-based construct validity study. Semin Arthritis Rheum. 2017 Jun;46(6):798-803. doi: 10.1016/j.semarthrit.2017.01.007. Epub 2017 Jan 18. Golder V, Kandane-Rathnayake R, Hoi AY, Huq M, Louthrenoo W, An Y, Li ZG, Luo SF, Sockalingam S, Lau CS, Mok MY, Lateef A, Franklyn K, Morton S, Navarra ST, Zamora L, Wu YJ, Hamijoyo L, Chan M, O'Neill S, Goldblatt F, Nikpour M, Morand EF; Asia-Pacific Lupus Collaboration. Association of the lupus low disease activity state (LLDAS) with health-related quality of life in a multinational prospective study. Arthritis Res Ther. 2017 Mar 20;19(1):62. doi: 10.1186/s13075-017-1256-6. Golder V, Kandane-Rathnayake R, Hoi AY, Huq M, Louthrenoo W, An Y, Li ZG, Luo SF, Sockalingam S, Lau CS, Lee AL, Mok MY, Lateef A, Franklyn K, Morton S, Navarra ST, Zamora L, Wu YJ, Hamijoyo L, Chan M, O'Neill S, Goldblatt F, Morand EF, Nikpour M; Asia-Pacific Lupus Collaboration. Frequency and predictors of the lupus low disease activity state in a multi-national and multi-ethnic cohort. Arthritis Res Ther. 2016 Nov 9;18(1):260. doi: 10.1186/s13075-016-1163-2. Franklyn K, Lau CS, Navarra SV, Louthrenoo W, Lateef A, Hamijoyo L, Wahono CS, Chen SL, Jin O, Morton S, Hoi A, Huq M, Nikpour M, Morand EF; Asia-Pacific Lupus Collaboration. Definition and initial validation of a Lupus Low Disease Activity State (LLDAS). Ann Rheum Dis. 2016 Sep;75(9):1615-21. doi: 10.1136/annrheumdis-2015-207726. Epub 2015 Oct 12. Kandane-Rathnayake R, Golder V, Louthrenoo W, Luo SF, Jan Wu YJ, Li Z, An Y, Lateef A, Sockalingam S, Navarra SV, Zamora L, Hamijoyo L, Katsumata Y, Harigai M, Chan M, O'Neill S, Goldblatt F, Hao Y, Zhang Z, Al-Saleh J, Khamashta M, Takeuchi T, Tanaka Y, Bae SC, Lau CS, Hoi A, Nikpour M, Morand EF. Development of the Asia Pacific Lupus Collaboration cohort. Int J Rheum Dis. 2019 Mar;22(3):425-433. doi: 10.1111/1756-185X.13431. Epub 2018 Nov 5. Golder V, Kandane-Rathnayake R, Huq M, Nim HT, Louthrenoo W, Luo SF, Wu YJ, Lateef A, Sockalingam S, Navarra SV, Zamora L, Hamijoyo L, Katsumata Y, Harigai M, Chan M, O'Neill S, Goldblatt F, Lau CS, Li ZG, Hoi A, Nikpour M, Morand EF; Asia-Pacific Lupus Collaboration. Lupus low disease activity state as a treatment endpoint for systemic lupus erythematosus: a prospective validation study. Lancet Rheumatol. 2019 Oct;1(2):e95-e102. doi: 10.1016/S2665-9913(19)30037-2. Epub 2019 Sep 6. Golder V, Kandane-Rathnayake R, Huq M, Louthrenoo W, Luo SF, Wu YJ, Lateef A, Sockalingam S, Navarra SV, Zamora L, Hamijoyo L, Katsumata Y, Harigai M, Chan M, O'Neill S, Goldblatt F, Lau CS, Li ZG, Hoi A, Nikpour M, Morand EF; Asia Pacific Lupus Collaboration. Evaluation of remission definitions for systemic lupus erythematosus: a prospective cohort study. Lancet Rheumatol. 2019 Oct;1(2):e103-e110. doi: 10.1016/S2665-9913(19)30048-7. Epub 2019 Sep 25.
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Public notes
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Contacts
Principal investigator
Name
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Eric Morand
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Address
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Monash University
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Email
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Contact person for public queries
Name
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Eric F Morand
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Address
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Phone
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+ 61 3 8572 2650
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Patient data collected and collated by the Asia Pacific Lupus Collaboration (APLC) is guided by strict protocols and procedures to ensure that privacy and other ethical principles are maintained at all times. Data sharing will strictly follows the APLC Data Access Policy. Under no circumstances will individual subject data be made available to any third parties.
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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/NCT03138941