Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region
Recruiting · NCT03138941 · Observational (researchers observe without assigning treatment) · Lead sponsor: Monash University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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.
Where it is running
20 locations listed.
- Division of Nephrology, Teaching Hospital Kandy, Sri Lanka - Kandy, Sri Lanka
- The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health - Kitakyushu, Japan
- Joint and Bone Center, University of Santo Tomas Hospital - Manila, Philippines
- Division of Rheumatology & Clinical Immunology, Department of Medicine, Queen Mary Hospital, the University of Hong Kong - Pok Fu Lam, Hong Kong
- University of the Philippines - Quezon City, Philippines
- Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases - Seoul, South Korea
- Rheumatology Division, University Medical Cluster, National University Hospital - Singapore, Singapore
- Division of Allergy, Immunology and Rheumatology, Taichung Veterans General Hospital - Taichung, Taiwan
- Department of Rheumatology, Allergy & Immunology, Tan Tock Seng Hospital - Tan Tock Seng, Singapore
- Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University - Tokyo, Japan
- Institute of Rheumatology, Tokyo Women's Medical University - Tokyo, Japan
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University Hospital - Chiang Mai, Muang District, Thailand
- Rheumatology Unit, Royal Adelaide Hospital - Adelaide, South Australia, Australia
- Department of Rheumatology, Flinders Medical Centre - Adelaide, South Australia, Australia
- Department of Rheumatology, Allergy and Immunology Chang Gung Memorial Hospital Chang Gung University - Guishan, Taoyuan County, Taiwan
- 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
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Padjadjaran University/ Hasan Sadikin General Hospital - Bandung, West Java, Indonesia
- 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