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Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region
NCT03138941 · Monash University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
In this study, patients with SLE will be followed for \~ 5 years. Regular recordings of the data needed to score LLDAS (disease activity and treatment domains, see Franklyn L et al, Ann Rheum Dis 2016) will be collected, as well as annual recording of lupus-related damage using the SLICC\_ACR Damage Index (SDI) and quality of life using the Short Form 36 version 2 (SF36v2).
At conclusion of primary data collection, the associate of LLDAS attainment, or sustained attainment, with protection from organ damage accrual will be ascertained.
Eligibility criteria
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.
Study design
Enrollment target: 5000 participants
Age groups: adult, older_adult
Timeline
Starts: 2013-09-01
Estimated completion: 2032-12-31
Last updated: 2024-12-12
Primary outcomes
- • SLICC-ACR Damage Index (Approximately 5-10 years)
Sponsor
Monash University · other
With: Flinders Medical Centre, Adelaide, AUSTRALIA, St. Vincent's Hospital, Melbourne, AUSTRALIA, Royal Adelaide Hospital, Adelaide, AUSTRALIA, The University of New South Wales, People's Hospital, Peking University Health Science Center, Beijing, CHINA, Peking University First Hospital, Beijing, CHINA, The University of Hong Kong, University of Padjadjaran, Bandung, INDONESIA, Tokyo Women's Medical University, JAPAN, University of Occupational and Environmental Health, JAPAN, Keio University, JAPAN, Hanyang University Hospital for Rheumatic Diseases, REPUBLIC OF KOREA, University of Santo Tomas Hospital, Philippines, National University Hospital, Singapore, Tan Tock Seng Hospital, Chang Gung Memorial Hospital, Taichung Veterans General Hospital, Chiang Mai University Hospital, THAILAND, Middlemore Hospital, New Zealand, North Shore Hospital, Auckland, NEW ZEALAND, Auckland District Health Board, Auckland, NEW ZEALAND, Teaching Hospital Kandy, SRI LANKA, University of the Philippines, Philippines
Contacts & investigators
ContactEric F Morand · contact · eric.morand@monash.edu · + 61 3 8572 2650
ContactRangi K KANDANE-RATHNAYAKE · contact · Rangi.Kandane-Rathnayake@monash.edu · + 61 3 8572 2561
InvestigatorEric Morand · study_chair, Monash University
All locations (20)
Rheumatology Unit, Royal Adelaide HospitalRecruiting
Adelaide, South Australia, Australia
Department of Rheumatology, Flinders Medical CentreRecruiting
Adelaide, South Australia, Australia
School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing & Health SciencesRecruiting
Clayton, Victoria, Australia
Department of Rheumatology, St Vincent's Hospital (Melbourne)Recruiting
Fitzroy, Victoria, Australia
Department of Rheumatology and Immunology, People's Hospital Peking University Health Science CenterRecruiting
Beijing, Western District, China
Rheumatology and Immunology department, Peking University First HospitalRecruiting
Beijing, Xicheng District, China
Division of Rheumatology & Clinical Immunology, Department of Medicine, Queen Mary Hospital, the University of Hong KongActive Not Recruiting
Pok Fu Lam, Hong Kong
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Padjadjaran University/ Hasan Sadikin General HospitalRecruiting
Bandung, West Java, Indonesia
The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental HealthRecruiting
Kitakyushu, Japan
Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio UniversityRecruiting
Tokyo, Japan
Institute of Rheumatology, Tokyo Women's Medical UniversityRecruiting
Tokyo, Japan
Joint and Bone Center, University of Santo Tomas HospitalRecruiting
Manila, Philippines
University of the PhilippinesRecruiting
Quezon City, Philippines
Rheumatology Division, University Medical Cluster, National University HospitalRecruiting
Singapore, Singapore
Department of Rheumatology, Allergy & Immunology, Tan Tock Seng HospitalRecruiting
Tan Tock Seng, Singapore
Department of Rheumatology, Hanyang University Hospital for Rheumatic DiseasesRecruiting
Seoul, South Korea
Division of Nephrology, Teaching Hospital Kandy, Sri LankaRecruiting
Kandy, Sri Lanka
Department of Rheumatology, Allergy and Immunology Chang Gung Memorial Hospital Chang Gung UniversityRecruiting
Guishan, Taoyuan County, Taiwan
Division of Allergy, Immunology and Rheumatology, Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University HospitalRecruiting
Chiang Mai, Muang District, Thailand