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.
| Facility | City | Region | Status |
|---|---|---|---|
| Rheumatology Unit, Royal Adelaide Hospital | Adelaide | South Australia | Recruiting |
| Department of Rheumatology, Flinders Medical Centre | Adelaide | South Australia | Recruiting |
| School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing & Health Sciences | Clayton | Victoria | Recruiting |
| Department of Rheumatology, St Vincent's Hospital (Melbourne) | Fitzroy | Victoria | Recruiting |
| Department of Rheumatology and Immunology, People's Hospital Peking University Health Science Center | Beijing | Western District | Recruiting |
| Rheumatology and Immunology department, Peking University First Hospital | Beijing | Xicheng District | Recruiting |
| Division of Rheumatology & Clinical Immunology, Department of Medicine, Queen Mary Hospital, the University of Hong Kong | Pok Fu Lam | Hong Kong | Active Not Recruiting |
| Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Padjadjaran University/ Hasan Sadikin General Hospital | Bandung | West Java | Recruiting |
| The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health | Kitakyushu | Japan | Recruiting |
| Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University | Tokyo | Japan | Recruiting |
| Institute of Rheumatology, Tokyo Women's Medical University | Tokyo | Japan | Recruiting |
| Joint and Bone Center, University of Santo Tomas Hospital | Manila | Philippines | Recruiting |
| University of the Philippines | Quezon City | Philippines | Recruiting |
| Rheumatology Division, University Medical Cluster, National University Hospital | Singapore | Singapore | Recruiting |
| Department of Rheumatology, Allergy & Immunology, Tan Tock Seng Hospital | Tan Tock Seng | Singapore | Recruiting |
| Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases | Seoul | South Korea | Recruiting |
| Division of Nephrology, Teaching Hospital Kandy, Sri Lanka | Kandy | Sri Lanka | Recruiting |
| Department of Rheumatology, Allergy and Immunology Chang Gung Memorial Hospital Chang Gung University | Guishan | Taoyuan County | Recruiting |
| Division of Allergy, Immunology and Rheumatology, Taichung Veterans General Hospital | Taichung | Taiwan | Recruiting |
| Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University Hospital | Chiang Mai | Muang District | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03138941 on ClinicalTrials.gov ↗ ← All trials in China