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

Status: Recruiting
Location: See all (20) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
Department of Rheumatology, Flinders Medical Centre
RECRUITING
Adelaide
Rheumatology Unit, Royal Adelaide Hospital
RECRUITING
Adelaide
School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing & Health Sciences
RECRUITING
Clayton
Department of Rheumatology, St Vincent's Hospital (Melbourne)
RECRUITING
Fitzroy
China
Department of Rheumatology and Immunology, People's Hospital Peking University Health Science Center
RECRUITING
Beijing
Rheumatology and Immunology department, Peking University First Hospital
RECRUITING
Beijing
Hong Kong Special Administrative Region
Division of Rheumatology & Clinical Immunology, Department of Medicine, Queen Mary Hospital, the University of Hong Kong
ACTIVE_NOT_RECRUITING
Pok Fu Lam
Indonesia
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Padjadjaran University/ Hasan Sadikin General Hospital
RECRUITING
Bandung
Japan
The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health
RECRUITING
Kitakyushu
Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University
RECRUITING
Tokyo
Institute of Rheumatology, Tokyo Women's Medical University
RECRUITING
Tokyo
Philippines
Joint and Bone Center, University of Santo Tomas Hospital
RECRUITING
Manila
University of the Philippines
RECRUITING
Quezon City
Republic of Korea
Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases
RECRUITING
Seoul
Singapore
Rheumatology Division, University Medical Cluster, National University Hospital
RECRUITING
Singapore
Department of Rheumatology, Allergy & Immunology, Tan Tock Seng Hospital
RECRUITING
Tan Tock Seng
Sri Lanka
Division of Nephrology, Teaching Hospital Kandy, Sri Lanka
RECRUITING
Kandy
Taiwan
Department of Rheumatology, Allergy and Immunology Chang Gung Memorial Hospital Chang Gung University
RECRUITING
Guishan
Division of Allergy, Immunology and Rheumatology, Taichung Veterans General Hospital
RECRUITING
Taichung
Thailand
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University Hospital
RECRUITING
Chiang Mai
Contact Information
Primary
Eric F Morand
eric.morand@monash.edu
+ 61 3 8572 2650
Backup
Rangi K KANDANE-RATHNAYAKE
Rangi.Kandane-Rathnayake@monash.edu
+ 61 3 8572 2561
Time Frame
Start Date: 2013-09-01
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 5000
Related Therapeutic Areas
Sponsors
Collaborators: The University of Hong Kong, National University Hospital, Singapore, North Shore Hospital, Auckland, NEW ZEALAND, Middlemore Hospital, New Zealand, St. Vincent's Hospital, Melbourne, AUSTRALIA, University of Santo Tomas Hospital, Philippines, Peking University First Hospital, Beijing, CHINA, Royal Adelaide Hospital, Adelaide, AUSTRALIA, Auckland District Health Board, Auckland, NEW ZEALAND, Flinders Medical Centre, Adelaide, AUSTRALIA, University of Padjadjaran, Bandung, INDONESIA, University of New South Wales, Sydney, AUSTRALIA, Hanyang University Hospital for Rheumatic Diseases, REPUBLIC OF KOREA, Taichung Veterans General Hospital, University of the Philippines, Philippines, People's Hospital, Peking University Health Science Center, Beijing, CHINA, Keio University, JAPAN, Tan Tock Seng Hospital, University of Occupational and Environmental Health, JAPAN, Chiang Mai University Hospital, THAILAND, Chang Gung Memorial Hospital, Teaching Hospital Kandy, SRI LANKA, Tokyo Women's Medical University, JAPAN
Leads: Monash University

This content was sourced from clinicaltrials.gov