Systemic Lupus ErythematosusAPLCLLDASNCT03138941
Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region
An observational study of Systemic Lupus Erythematosus, run by Monash University at 20 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 5,000 participants
- Where
- 20 sitesin 11 countries
- Study dates
- 1 Sep 2013to 31 Dec 2032
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult SLE patients with confirmed lupus
Who may be able to join
- 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.
Who cannot join
- Patients less than 18 years of age and patients who are unable to consent are excluded from the study.
Trial locations and contacts
20 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 11 countries
Australia4 sites, 4 recruiting
- Recruiting
Rheumatology Unit, Royal Adelaide Hospital
Adelaide, South Australia, 5000
Fiona Goldblatt, Fiona.Goldblatt@health.sa.gov.au
- Recruiting
Department of Rheumatology, Flinders Medical Centre
Adelaide, South Australia, 5042
Fiona Goldblatt, Fiona.Goldblatt@health.sa.gov.au
- Recruiting
School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing & Health Sciences
Clayton, Victoria, 3168
Eric Morand, eric.morand@monash.edu
Alberta Hoi, alberta.hoi@monash.edu
- Recruiting
Department of Rheumatology, St Vincent's Hospital (Melbourne)
Fitzroy, Victoria, 3065
Mandana Nikpour, m.nikpour@unimelb.edu.au
Japan3 sites, 3 recruiting
- Recruiting
The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health
Kitakyushu, 807-8555
Yoshiya Tanaka, tanaka@med.uoeh-u.ac.jp
Yusuke Miyasaki
- Recruiting
Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University
Tokyo, 160-8582
Tsutomu Takeuchi, tsutake@z5.keio.jp
- Recruiting
Institute of Rheumatology, Tokyo Women's Medical University
Tokyo, 162-0054
Masayoshi Harigai, mharigai.mpha@gmail.com
Yasuhiro Katsumata, katsumata@ior.twmu.ac.jp
China2 sites, 2 recruiting
- Recruiting
Department of Rheumatology and Immunology, People's Hospital Peking University Health Science Center
Beijing, Western District, 100044
Zhan Guo Li, li99@bjmu.edu.cn
Yuan An, anyfield@163.com
- Recruiting
Rheumatology and Immunology department, Peking University First Hospital
Beijing, Xicheng District, 100034
Zhuoli Zhang, zhuoli.zhang@126.com
Yanjie Hao, hyjbb@163.com
Philippines2 sites, 2 recruiting
- Recruiting
Joint and Bone Center, University of Santo Tomas Hospital
Manila, 1008
Sandra Navarra, sandra_navarra@yahoo.com
- Recruiting
University of the Philippines
Quezon City
Michael Tee, +63 9 17833 6398, mltee@up.edu.ph
Singapore2 sites, 2 recruiting
- Recruiting
Rheumatology Division, University Medical Cluster, National University Hospital
Singapore, 119074
Aisha Lateef, Aisha_LATEEF@nuhs.edu.sg
- Recruiting
Department of Rheumatology, Allergy & Immunology, Tan Tock Seng Hospital
Tan Tock Seng, 308433
Madelynn Chan, madelynn_chan@ttsh.com.sg
Taiwan2 sites, 2 recruiting
- Recruiting
Department of Rheumatology, Allergy and Immunology Chang Gung Memorial Hospital Chang Gung University
Guishan, Taoyuan County, 333
Shue Fen Luo, lsf00076@adm.cgmh.org.tw
Yeong-Jian Wu, yjwu1962@gmail.com
- Recruiting
Division of Allergy, Immunology and Rheumatology, Taichung Veterans General Hospital
Taichung, 40705
Yi-Hsing Chen, dr.yihsing@gmail.com
Hong Kong1 site
- Active, not recruiting
Division of Rheumatology & Clinical Immunology, Department of Medicine, Queen Mary Hospital, the University of Hong Kong
Pok Fu Lam
Indonesia1 site, 1 recruiting
- Recruiting
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Padjadjaran University/ Hasan Sadikin General Hospital
Bandung, West Java
Laniyati Hamijoyo, hamijoyo@yahoo.com
South Korea1 site, 1 recruiting
- Recruiting
Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases
Seoul, 04763
Sang-Cheol Bae, scbae@hanyang.ac.kr
Sri Lanka1 site, 1 recruiting
- Recruiting
Division of Nephrology, Teaching Hospital Kandy, Sri Lanka
Kandy
BMDB Basnayake, MD, +94772252297, bmdbbasnayake@yahoo.com
Thailand1 site, 1 recruiting
- Recruiting
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University Hospital
Chiang Mai, Muang District, 50200
Worawit Louthrenoo, wlouthre@gmail.com
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Systemic Lupus Erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
SLICC-ACR Damage Index
Organ damage accrual
Measured: Approximately 5-10 years
Secondary outcomes (2)
SFv2-36
Quality of Life
Measured: Approximately 5-10 years
Mortality
Mortality
Measured: Approximately 5-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start1 Sep 2013
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- Flinders Medical Centre, Adelaide, AUSTRALIA, St. Vincent's Hospital, Melbourne, AUSTRALIA, Royal Adelaide Hospital, The University of New South Wales, Peking University Health Science Center, Peking University First Hospital, The University of Hong Kong, University of Padjadjaran, Bandung, INDONESIA, Tokyo Women's Medical University, JAPAN, University of Occupational and Environmental Health, Keio University, JAPAN, Hanyang University Seoul Hospital, 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, New Zealand, Auckland District Health Board, Teaching Hospital Kandy, SRI LANKA, University of the Philippines
- Responsible party
- Sponsor
- Investigators
- Eric Morand, Study chair, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138941
- Sponsor's protocol ID
- APLC LLDAS Study
- Acronym
- APLCLLDAS
- Status last verified
- Nov 2024
- First submitted
- 1 May 2017
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 28216192Golder 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.
PubMed 28320433Golder 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.
PubMed 27829463Franklyn 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.
PubMed 26458737Kandane-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.
PubMed 30398013Golder 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.
PubMed 38229349Golder 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.
PubMed 38229337Kandane-Rathnayake R, Zolio L, Choi JI, 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, Chan M, Kikuchi J, Takeuchi T, Oon S, Bae SC, Goldblatt F, O'Neill S, Ng KPL, Law A, Basnayake BMDB, Tugnet N, Kumar S, Tee C, Tee M, Tanaka Y, Lau CS, Hoi A, Nikpour M, Morand EF. Predictors of damage accrual by organ domain in systemic lupus erythematosus. Rheumatology (Oxford). 2026 Feb 4;65(2):keaf610. doi: 10.1093/rheumatology/keaf610.
PubMed 41252474Kandane-Rathnayake R, Hoi A, Louthrenoo W, Golder V, Chen YH, Cho J, Lateef A, Hamijoyo L, Luo SF, Wu YJ, Navarra S, Zamora L, Li Z, Yao H, Sockalingam S, Katsumata Y, Hao Y, Zhang Z, Basnayake BMDB, Chan M, Kikuchi J, Kaneko Y, Takeuchi T, Oon S, Bae SC, O'Neill S, Hassett G, Goldblatt F, Ng KPL, Poh YJ, Tugnet N, Sapsford M, Chan S, Tee C, Tee ML, Ohkubo N, Tanaka Y, Lau CS, Nikpour M, Morand E. Impact of glucocorticoid dose threshold in definition of lupus low disease activity state: a multinational observational cohort study. Lupus Sci Med. 2025 Nov 11;12(2):e001714. doi: 10.1136/lupus-2025-001714.
PubMed 41219118Kandane-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, Lau CS, Nikpour M, Morand EF, Hoi A. Association of lupus low disease activity state and remission with reduced organ damage and flare in systemic lupus erythematosus patients with high disease activity: a multi-national, longitudinal cohort study. Rheumatology (Oxford). 2025 May 1;64(5):2741-2748. doi: 10.1093/rheumatology/keae631.
PubMed 39656834Golder 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.
PubMed 38876129Golder 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.
PubMed 38490668Kandane-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.
PubMed 38261390
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region
- ClinicalTrials.gov ID
- NCT03138941
- Acronym / sponsor ID
- APLCLLDAS / APLC LLDAS Study
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- Flinders Medical Centre, Adelaide, AUSTRALIA, St. Vincent's Hospital, Melbourne, AUSTRALIA, Royal Adelaide Hospital, The University of New South Wales, Peking University Health Science Center, Peking University First Hospital, The University of Hong Kong, University of Padjadjaran, Bandung, INDONESIA, Tokyo Women's Medical University, JAPAN, University of Occupational and Environmental Health, Keio University, JAPAN, Hanyang University Seoul Hospital, 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, New Zealand, Auckland District Health Board, Teaching Hospital Kandy, SRI LANKA, University of the Philippines
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult SLE patients with confirmed lupus
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients less than 18 years of age and patients who are unable to consent are excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SLICC-ACR Damage Index
Time frame: Approximately 5-10 years
Organ damage accrual
2 secondary outcomes
SFv2-36
Time frame: Approximately 5-10 years
Mortality
Time frame: Approximately 5-10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Background: PubMed 28216192Golder 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.
- Background: PubMed 28320433Golder 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.
- Background: PubMed 27829463Golder 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.
- Background: PubMed 26458737Franklyn 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.
- Background: PubMed 30398013Kandane-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.
- Background: PubMed 38229349Golder 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.
- Background: PubMed 38229337Golder 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.
- Derived from this study: PubMed 41252474Kandane-Rathnayake R, Zolio L, Choi JI, 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, Chan M, Kikuchi J, Takeuchi T, Oon S, Bae SC, Goldblatt F, O'Neill S, Ng KPL, Law A, Basnayake BMDB, Tugnet N, Kumar S, Tee C, Tee M, Tanaka Y, Lau CS, Hoi A, Nikpour M, Morand EF. Predictors of damage accrual by organ domain in systemic lupus erythematosus. Rheumatology (Oxford). 2026 Feb 4;65(2):keaf610. doi: 10.1093/rheumatology/keaf610.
- Derived from this study: PubMed 41219118Kandane-Rathnayake R, Hoi A, Louthrenoo W, Golder V, Chen YH, Cho J, Lateef A, Hamijoyo L, Luo SF, Wu YJ, Navarra S, Zamora L, Li Z, Yao H, Sockalingam S, Katsumata Y, Hao Y, Zhang Z, Basnayake BMDB, Chan M, Kikuchi J, Kaneko Y, Takeuchi T, Oon S, Bae SC, O'Neill S, Hassett G, Goldblatt F, Ng KPL, Poh YJ, Tugnet N, Sapsford M, Chan S, Tee C, Tee ML, Ohkubo N, Tanaka Y, Lau CS, Nikpour M, Morand E. Impact of glucocorticoid dose threshold in definition of lupus low disease activity state: a multinational observational cohort study. Lupus Sci Med. 2025 Nov 11;12(2):e001714. doi: 10.1136/lupus-2025-001714.
- Derived from this study: PubMed 39656834Kandane-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, Lau CS, Nikpour M, Morand EF, Hoi A. Association of lupus low disease activity state and remission with reduced organ damage and flare in systemic lupus erythematosus patients with high disease activity: a multi-national, longitudinal cohort study. Rheumatology (Oxford). 2025 May 1;64(5):2741-2748. doi: 10.1093/rheumatology/keae631.
- Derived from this study: PubMed 38876129Golder 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.
- Derived from this study: PubMed 38490668Golder 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Morand study chair
Monash University
20 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Monash University at 20 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Australia, Japan, China, Philippines, Singapore and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric F Morand (+ 61 3 8572 2650, eric.morand@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLICC-ACR Damage Index (time frame: Approximately 5-10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03138941, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.