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

December 9, 2024 updated by: Monash University

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
      • Adelaide, South Australia, Australia, 5042
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing & Health Sciences
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Vera Golder
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • Department of Rheumatology, St Vincent's Hospital (Melbourne)
        • Contact:
  • China
    • Western District
      • Beijing, Western District, China, 100044
        • Recruiting
        • Department of Rheumatology and Immunology, People's Hospital Peking University Health Science Center
        • Contact:
        • Contact:
    • Xicheng District
      • Beijing, Xicheng District, China, 100034
        • Recruiting
        • Rheumatology and Immunology department, Peking University First Hospital
        • Contact:
        • Contact:
  • Hong Kong
      • Pok Fu Lam, Hong Kong
        • Active, not recruiting
        • Division of Rheumatology & Clinical Immunology, Department of Medicine, Queen Mary Hospital, the University of Hong Kong
  • Indonesia
    • West Java
      • Bandung, West Java, Indonesia
        • Recruiting
        • Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Padjadjaran University/ Hasan Sadikin General Hospital
        • Contact:
  • Japan
      • Kitakyushu, Japan, 807-8555
        • Recruiting
        • The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health
        • Contact:
        • Sub-Investigator:
          • Yusuke Miyasaki
      • Tokyo, Japan, 160-8582
        • Recruiting
        • Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University
        • Contact:
      • Tokyo, Japan, 162-0054
  • Korea, Republic of
      • Seoul, Korea, Republic of, 04763
        • Recruiting
        • Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases
        • Contact:
  • Philippines
      • Manila, Philippines, 1008
        • Recruiting
        • Joint and Bone Center, University of Santo Tomas Hospital
        • Contact:
      • Quezon City, Philippines
        • Recruiting
        • University of the Philippines
        • Contact:
  • Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • Rheumatology Division, University Medical Cluster, National University Hospital
        • Contact:
      • Tan Tock Seng, Singapore, 308433
        • Recruiting
        • Department of Rheumatology, Allergy & Immunology, Tan Tock Seng Hospital
        • Contact:
  • Sri Lanka
      • Kandy, Sri Lanka
        • Recruiting
        • Division of Nephrology, Teaching Hospital Kandy, Sri Lanka
        • Contact:
  • Taiwan
      • Taichung, Taiwan, 40705
        • Recruiting
        • Division of Allergy, Immunology and Rheumatology, Taichung Veterans General Hospital
        • Contact:
    • Taoyuan County
      • Guishan, Taoyuan County, Taiwan, 333
        • Recruiting
        • Department of Rheumatology, Allergy and Immunology Chang Gung Memorial Hospital Chang Gung University
        • Contact:
        • Contact:
  • Thailand
    • Muang District
      • Chiang Mai, Muang District, Thailand, 50200
        • Recruiting
        • Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult SLE patients with confirmed lupus

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SLICC-ACR Damage Index
Time Frame: Approximately 5-10 years
Organ damage accrual
Approximately 5-10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SFv2-36
Time Frame: Approximately 5-10 years
Quality of Life
Approximately 5-10 years
Mortality
Time Frame: Approximately 5-10 years
Mortality
Approximately 5-10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monash University

Collaborators

National University Hospital, Singapore
Chang Gung Memorial Hospital
Tan Tock Seng Hospital
Taichung Veterans General Hospital
Middlemore Hospital, New Zealand
University of Santo Tomas Hospital, Philippines
Flinders Medical Centre, Adelaide, AUSTRALIA
St. Vincent's Hospital, Melbourne, AUSTRALIA
Royal Adelaide Hospital, Adelaide, AUSTRALIA
University of New South Wales, Sydney, AUSTRALIA
People's Hospital, Peking University Health Science Center, Beijing, CHINA
Peking University First Hospital, Beijing, CHINA
The University of Hong Kong, HONG KONG
University of Padjadjaran, Bandung, INDONESIA
Tokyo Women's Medical University, JAPAN
University of Occupational and Environmental Health, JAPAN
Keio University, JAPAN
Hanyang University Hospital for Rheumatic Diseases, REPUBLIC OF KOREA
Chiang Mai University Hospital, THAILAND
North Shore Hospital, Auckland, NEW ZEALAND
Auckland District Health Board, Auckland, NEW ZEALAND
Teaching Hospital Kandy, SRI LANKA
University of the Philippines, Philippines

Investigators

  • Study Chair: Eric Morand, Monash University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

May 1, 2017

First Submitted That Met QC Criteria

May 1, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Actual)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APLC LLDAS Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient data collected and collated by the Asia Pacific Lupus Collaboration (APLC) is guided by strict protocols and procedures to ensure that privacy and other ethical principles are maintained at all times. Data sharing will strictly follows the APLC Data Access Policy. Under no circumstances will individual subject data be made available to any third parties.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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