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

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.

Conditions

• Systemic Lupus Erythematosus

Sponsors & Collaborators

• Flinders Medical Centre, Adelaide, AUSTRALIA

  collaborator UNKNOWN

• St. Vincent's Hospital, Melbourne, AUSTRALIA

  collaborator UNKNOWN

• Royal Adelaide Hospital, Adelaide, AUSTRALIA

  collaborator UNKNOWN

• University of New South Wales, Sydney, AUSTRALIA

  collaborator UNKNOWN

• People's Hospital, Peking University Health Science Center, Beijing, CHINA

  collaborator UNKNOWN

• Peking University First Hospital, Beijing, CHINA

  collaborator UNKNOWN

• The University of Hong Kong, HONG KONG

  collaborator UNKNOWN

• University of Padjadjaran, Bandung, INDONESIA

  collaborator UNKNOWN

• Tokyo Women's Medical University, JAPAN

  collaborator UNKNOWN

• University of Occupational and Environmental Health, JAPAN

  collaborator UNKNOWN

• Keio University, JAPAN

  collaborator UNKNOWN

• Hanyang University Hospital for Rheumatic Diseases, REPUBLIC OF KOREA

  collaborator UNKNOWN

• University of Santo Tomas Hospital, Philippines

  collaborator OTHER

• National University Hospital, Singapore

  collaborator OTHER

• Tan Tock Seng Hospital

  collaborator OTHER

• Chang Gung Memorial Hospital

  collaborator OTHER

• Taichung Veterans General Hospital

  collaborator OTHER

• Chiang Mai University Hospital, THAILAND

  collaborator UNKNOWN

• Middlemore Hospital, New Zealand

  collaborator OTHER

• North Shore Hospital, Auckland, NEW ZEALAND

  collaborator UNKNOWN

• Auckland District Health Board, Auckland, NEW ZEALAND

  collaborator UNKNOWN

• Teaching Hospital Kandy, SRI LANKA

  collaborator UNKNOWN

• University of the Philippines, Philippines

  collaborator UNKNOWN

• Monash University

  lead OTHER

Principal Investigators

• Eric Morand · Monash University

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-01

Primary Completion

2027-12-31

Completion

2032-12-31

Countries

• Australia
• China
• Hong Kong
• Indonesia
• Japan
• Philippines
• Singapore
• South Korea
• Sri Lanka
• Taiwan
• Thailand

Study Locations