Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region
- Conditions
- Systemic Lupus Erythematosus
- Registration Number
- NCT03138941
- Lead Sponsor
- Monash University
- Brief 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).
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- 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.
- Patients less than 18 years of age and patients who are unable to consent are excluded from the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SLICC-ACR Damage Index Approximately 5-10 years Organ damage accrual
- Secondary Outcome Measures
Name Time Method SFv2-36 Approximately 5-10 years Quality of Life
Mortality Approximately 5-10 years Mortality
Trial Locations
- Locations (20)
School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing & Health Sciences
🇦🇺Clayton, Victoria, Australia
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
Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases
🇰🇷Seoul, Korea, Republic of
Rheumatology Division, University Medical Cluster, National University Hospital
🇸🇬Singapore, Singapore
Joint and Bone Center, University of Santo Tomas Hospital
🇵ðŸ‡Manila, Philippines
University of the Philippines
🇵ðŸ‡Quezon City, Philippines
Department of Rheumatology, Allergy & Immunology, Tan Tock Seng Hospital
🇸🇬Tan Tock Seng, Singapore
Department of Rheumatology, Allergy and Immunology Chang Gung Memorial Hospital Chang Gung University
🇨🇳Guishan, Taoyuan County, Taiwan
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University Hospital
🇹ðŸ‡Chiang Mai, Muang District, Thailand
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 Nephrology, Teaching Hospital Kandy, Sri Lanka
🇱🇰Kandy, Sri Lanka
Division of Allergy, Immunology and Rheumatology, Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Rheumatology Unit, Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Department of Rheumatology, Flinders Medical Centre
🇦🇺Adelaide, South Australia, Australia
Department of Rheumatology, St Vincent's Hospital (Melbourne)
🇦🇺Fitzroy, Victoria, Australia
Division of Rheumatology & Clinical Immunology, Department of Medicine, Queen Mary Hospital, the University of Hong Kong
ðŸ‡ðŸ‡°Pok Fu Lam, Hong Kong