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Study identifier: NCT03138941 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region

Condition: Systemic Lupus Erythematosus  ·  Sponsor: Monash University

PhaseN/A
Planned participants5000
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

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. 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 pat…

This description comes directly from the study's public registry record.

Talk to the study team

Eric F Morand  ·  + 61 3 8572 2650  ·  eric.morand@monash.edu

Rangi K KANDANE-RATHNAYAKE  ·  + 61 3 8572 2561  ·  Rangi.Kandane-Rathnayake@monash.edu

Always discuss trial participation with your own doctor first.

Locations (20)

Rheumatology Unit, Royal Adelaide HospitalAdelaide, South Australia, AustraliaRecruiting
Department of Rheumatology, Flinders Medical CentreAdelaide, South Australia, AustraliaRecruiting
School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing & Health SciencesClayton, Victoria, AustraliaRecruiting
Department of Rheumatology, St Vincent's Hospital (Melbourne)Fitzroy, Victoria, AustraliaRecruiting
Department of Rheumatology and Immunology, People's Hospital Peking University Health Science CenterBeijing, Western District, ChinaRecruiting
Rheumatology and Immunology department, Peking University First HospitalBeijing, Xicheng District, ChinaRecruiting
Division of Rheumatology & Clinical Immunology, Department of Medicine, Queen Mary Hospital, the University of Hong KongPok Fu Lam, Hong KongActive Not Recruiting
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Padjadjaran University/ Hasan Sadikin General HospitalBandung, West Java, IndonesiaRecruiting
The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental HealthKitakyushu, JapanRecruiting
Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio UniversityTokyo, JapanRecruiting
Institute of Rheumatology, Tokyo Women's Medical UniversityTokyo, JapanRecruiting
Joint and Bone Center, University of Santo Tomas HospitalManila, PhilippinesRecruiting

+ 8 more locations — full list on the registry record.

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