Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region
NCT ID: NCT03138941
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2013-09-01
2032-12-31
Brief Summary
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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.
Detailed Description
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At conclusion of primary data collection, the associate of LLDAS attainment, or sustained attainment, with protection from organ damage accrual will be ascertained.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
All patients must be over the age of 18 and competent to provide written consent.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Flinders Medical Centre, Adelaide, AUSTRALIA
UNKNOWN
St. Vincent's Hospital, Melbourne, AUSTRALIA
UNKNOWN
Royal Adelaide Hospital, Adelaide, AUSTRALIA
UNKNOWN
University of New South Wales, Sydney, AUSTRALIA
UNKNOWN
People's Hospital, Peking University Health Science Center, Beijing, CHINA
UNKNOWN
Peking University First Hospital, Beijing, CHINA
UNKNOWN
The University of Hong Kong, HONG KONG
UNKNOWN
University of Padjadjaran, Bandung, INDONESIA
UNKNOWN
Tokyo Women's Medical University, JAPAN
UNKNOWN
University of Occupational and Environmental Health, JAPAN
UNKNOWN
Keio University, JAPAN
UNKNOWN
Hanyang University Hospital for Rheumatic Diseases, REPUBLIC OF KOREA
UNKNOWN
University of Santo Tomas Hospital, Philippines
OTHER
National University Hospital, Singapore
OTHER
Tan Tock Seng Hospital
OTHER
Chang Gung Memorial Hospital
OTHER
Taichung Veterans General Hospital
OTHER
Chiang Mai University Hospital, THAILAND
UNKNOWN
Middlemore Hospital, New Zealand
OTHER
North Shore Hospital, Auckland, NEW ZEALAND
UNKNOWN
Auckland District Health Board, Auckland, NEW ZEALAND
UNKNOWN
Teaching Hospital Kandy, SRI LANKA
UNKNOWN
University of the Philippines, Philippines
UNKNOWN
Monash University
OTHER
Responsible Party
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Principal Investigators
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Eric Morand
Role: STUDY_CHAIR
Monash University
Locations
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Rheumatology Unit, Royal Adelaide Hospital
Adelaide, South Australia, Australia
Department of Rheumatology, Flinders Medical Centre
Adelaide, South Australia, Australia
School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing & Health Sciences
Clayton, Victoria, Australia
Department of Rheumatology, St Vincent's Hospital (Melbourne)
Fitzroy, Victoria, Australia
Department of Rheumatology and Immunology, People's Hospital Peking University Health Science Center
Beijing, Western District, China
Rheumatology and Immunology department, Peking University First Hospital
Beijing, Xicheng District, China
Division of Rheumatology & Clinical Immunology, Department of Medicine, Queen Mary Hospital, the University of Hong Kong
Pok Fu Lam, , Hong Kong
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Padjadjaran University/ Hasan Sadikin General Hospital
Bandung, West Java, Indonesia
The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health
Kitakyushu, , Japan
Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University
Tokyo, , Japan
Institute of Rheumatology, Tokyo Women's Medical University
Tokyo, , Japan
Joint and Bone Center, University of Santo Tomas Hospital
Manila, , Philippines
University of the Philippines
Quezon City, , Philippines
Rheumatology Division, University Medical Cluster, National University Hospital
Singapore, , Singapore
Department of Rheumatology, Allergy & Immunology, Tan Tock Seng Hospital
Tan Tock Seng, , Singapore
Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases
Seoul, , South Korea
Division of Nephrology, Teaching Hospital Kandy, Sri Lanka
Kandy, , Sri Lanka
Department of Rheumatology, Allergy and Immunology Chang Gung Memorial Hospital Chang Gung University
Guishan, Taoyuan County, Taiwan
Division of Allergy, Immunology and Rheumatology, Taichung Veterans General Hospital
Taichung, , Taiwan
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University Hospital
Chiang Mai, Muang District, Thailand
Countries
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Central Contacts
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Facility Contacts
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Fiona Goldblatt
Role: primary
Fiona Goldblatt
Role: primary
Eric Morand
Role: primary
Alberta Hoi
Role: backup
Mandana Nikpour
Role: primary
Zhan Guo Li
Role: primary
Yuan An
Role: backup
Zhuoli Zhang
Role: primary
Yanjie Hao
Role: backup
Laniyati Hamijoyo
Role: primary
Yoshiya Tanaka
Role: primary
Tsutomu Takeuchi
Role: primary
Masayoshi Harigai
Role: primary
Yasuhiro Katsumata
Role: backup
Sandra Navarra
Role: primary
Michael Tee
Role: primary
Aisha Lateef
Role: primary
Madelynn Chan
Role: primary
Sang-Cheol Bae
Role: primary
BMDB Basnayake, MD
Role: primary
Shue Fen Luo
Role: primary
Yeong-Jian Wu
Role: backup
Yi-Hsing Chen
Role: primary
Worawit Louthrenoo
Role: primary
References
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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.
Golder V, Kandane-Rathnayake R, Li N, Louthrenoo W, Chen YH, Cho J, Lateef A, Hamijoyo L, Luo SF, Wu YJ, Navarra SV, Zamora L, Li Z, Sockalingam S, Katsumata Y, Harigai M, Hao Y, Zhang Z, Basnayake D, Chan M, Kikuchi J, Takeuchi T, Bae SC, Goldblatt F, Oon S, O'Neill S, Ng K, Law A, Tugnet N, Kumar S, Tee C, Tee M, Ohkubo N, Tanaka Y, Lau CS, Hoi A, Nikpour M, Morand EF; Asia Pacific Lupus Collaboration. Association of sustained lupus low disease activity state with improved outcomes in systemic lupus erythematosus: a multinational prospective cohort study. Lancet Rheumatol. 2024 Aug;6(8):e528-e536. doi: 10.1016/S2665-9913(24)00121-8. Epub 2024 Jun 11.
Golder V, Kandane-Rathnayake R, Louthrenoo W, Chen YH, Cho J, Lateef A, Hamijoyo L, Luo SF, Wu YJ, Navarra SV, Zamora L, Li Z, Sockalingam S, Katsumata Y, Harigai M, Hao Y, Zhang Z, Basnayake BMDB, Chan M, Kikuchi J, Takeuchi T, Bae SC, Oon S, O'Neill S, Goldblatt F, Ng KPL, Law A, Tugnet N, Kumar S, Tee C, Tee M, Ohkubo N, Tanaka Y, Lau CS, Nikpour M, Hoi A, Morand EF; Asia Pacific Lupus Collaboration. Comparison of Attainment and Protective Effects of Lupus Low Disease Activity State in Patients With Newly Diagnosed Versus Established Systemic Lupus Erythematosus. J Rheumatol. 2024 Aug 1;51(8):790-797. doi: 10.3899/jrheum.2023-0900.
Kandane-Rathnayake R, Golder V, Louthrenoo W, Chen YH, Cho J, Lateef A, Hamijoyo L, Luo SF, Wu YJ, Navarra SV, Zamora L, Li Z, Sockalingam S, Katsumata Y, Harigai M, Hao Y, Zhang Z, Basnayake BMDB, Chan M, Kikuchi J, Takeuchi T, Bae SC, Oon S, O'Neill S, Goldblatt F, Ng KPL, Law A, Tugnet N, Kumar S, Tee C, Tee M, Ohkubo N, Tanaka Y, Yu D, Karyekar CS, Sing Lau C, Monk JA, Nikpour M, Hoi A, Morand EF; Asia-Pacific Lupus Collaboration. Lupus low disease activity state and remission and risk of mortality in patients with systemic lupus erythematosus: a prospective, multinational, longitudinal cohort study. Lancet Rheumatol. 2022 Dec;4(12):e822-e830. doi: 10.1016/S2665-9913(22)00304-6. Epub 2022 Oct 22.
Related Links
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Related Info
Other Identifiers
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APLC LLDAS Study
Identifier Type: -
Identifier Source: org_study_id