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

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ClinicalTrials.gov Identifier: NCT03138941
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : October 2, 2019
Sponsor:
Collaborators:
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
University of Malaya
University of Santo Tomas Hospital, Philippines
National University Hospital, Singapore
Tan Tock Seng Hospital
Chang Gung Memorial Hospital
Taichung Veterans General Hospital
Chiang Mai University Hospital, THAILAND
Dubai Hospital, Dubai, UNITED ARAB EMIRATES
Middlemore Hospital, New Zealand
North Shore Hospital, Auckland, NEW ZEALAND
Auckland District Health Board, Auckland, NEW ZEALAND
Teaching Hospital Kandy, SRI LANKA
Sir Ganga Ram Hospital, New Delhi, INDIA
University of the Philippines, Philippines
Information provided by (Responsible Party):
Eric F Morand, 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.


Condition or disease
Systemic Lupus Erythematosus

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region
Actual Study Start Date : September 1, 2013
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. SLICC-ACR Damage Index [ Time Frame: Approximately 5-10 years ]
    Organ damage accrual


Secondary Outcome Measures :
  1. SFv2-36 [ Time Frame: Approximately 5-10 years ]
    Quality of Life

  2. Mortality [ Time Frame: Approximately 5-10 years ]
    Mortality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult SLE patients with confirmed lupus
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138941


Contacts
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Contact: Eric F Morand + 61 3 8572 2650 eric.morand@monash.edu
Contact: Rangi K KANDANE-RATHNAYAKE + 61 3 8572 2561 Rangi.Kandane-Rathnayake@monash.edu

Locations
Hide Hide 24 study locations
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Australia, New South Wales
Liverpool Hospital Not yet recruiting
Liverpool, New South Wales, Australia, 2170
Contact: Sean O'Neill       Sean.O'Neill@sswahs.nsw.gov.au   
Australia, South Australia
Rheumatology Unit, Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Fiona Goldblatt       Fiona.Goldblatt@health.sa.gov.au   
Department of Rheumatology, Flinders Medical Centre Recruiting
Adelaide, South Australia, Australia, 5042
Contact: Fiona Goldblatt       Fiona.Goldblatt@health.sa.gov.au   
Australia, Victoria
School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing & Health Sciences Recruiting
Clayton, Victoria, Australia, 3168
Contact: Eric Morand       eric.morand@monash.edu   
Contact: Alberta Hoi       alberta.hoi@monash.edu   
Sub-Investigator: Vera Golder         
Department of Rheumatology, St Vincent's Hospital (Melbourne) Recruiting
Fitzroy, Victoria, Australia, 3065
Contact: Mandana Nikpour       m.nikpour@unimelb.edu.au   
China, Western District
Department of Rheumatology and Immunology, People's Hospital Peking University Health Science Center Recruiting
Beijing, Western District, China, 100044
Contact: Zhan Guo Li       li99@bjmu.edu.cn   
Contact: Yuan An       anyfield@163.com   
China, Xicheng District
Rheumatology and Immunology department, Peking University First Hospital Recruiting
Beijing, Xicheng District, China, 100034
Contact: Zhuoli Zhang       zhuoli.zhang@126.com   
Contact: Yanjie Hao       hyjbb@163.com   
Hong Kong
Division of Rheumatology & Clinical Immunology, Department of Medicine, Queen Mary Hospital, the University of Hong Kong Active, not recruiting
Pok Fu Lam, Hong Kong
India
Division of Paediatric Rheumatology, Institute of Child Health, Sir Ganga Ram Hospital Not yet recruiting
New Delhi, India, 110060
Contact: Sujata Sawheny, MD    +919811444116    drsujatasawhney@gmail.com   
Indonesia
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Padjadjaran University/ Hasan Sadikin General Hospital Recruiting
Bandung, West Java, Indonesia
Contact: Laniyati Hamijoyo       hamijoyo@yahoo.com   
Japan
The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Recruiting
Japan, Japan, 807-8555
Contact: Yoshiya Tanaka       tanaka@med.uoeh-u.ac.jp   
Contact: Kazuhisa Nakano         
Sub-Investigator: Ippei Miyagawa         
Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University Recruiting
Tokyo, Japan, 160-8582
Contact: Tsutomu Takeuchi       tsutake@z5.keio.jp   
Institute of Rheumatology, Tokyo Women's Medical University Recruiting
Tokyo, Japan, 162-0054
Contact: Masayoshi Harigai       mharigai.mpha@gmail.com   
Contact: Yasuhiro Katsumata       katsumata@ior.twmu.ac.jp   
Korea, Republic of
Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases Recruiting
Seoul, Korea, Republic of, 04763
Contact: Sang-Cheol Bae       scbae@hanyang.ac.kr   
Malaysia
Department of Medicine, Faculty of Medicine Building, University of Malaya Active, not recruiting
Kuala Lumpur, Malaysia, 50603
Philippines
Joint and Bone Center, University of Santo Tomas Hospital Recruiting
Manila, Philippines, 1008
Contact: Sandra Navarra       sandra_navarra@yahoo.com   
University of the Philippines Recruiting
Quezon City, Philippines
Contact: Michael Tee    +63 9 17833 6398    mltee@up.edu.ph   
Singapore
Rheumatology Division, University Medical Cluster, National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Aisha Lateef       Aisha_LATEEF@nuhs.edu.sg   
Department of Rheumatology, Allergy & Immunology, Tan Tock Seng Hospital Recruiting
Tan Tock Seng, Singapore, 308433
Contact: Madelynn Chan       madelynn_chan@ttsh.com.sg   
Sri Lanka
Division of Nephrology, Teaching Hospital Kandy, Sri Lanka Recruiting
Kandy, Sri Lanka
Contact: BMDB Basnayake, MD    +94772252297    bmdbbasnayake@yahoo.com   
Taiwan
Department of Rheumatology, Allergy and Immunology Chang Gung Memorial Hospital Chang Gung University Recruiting
Guishan, Taoyuan County, Taiwan, 333
Contact: Shue Fen Luo       lsf00076@adm.cgmh.org.tw   
Contact: Yeong-Jian Wu       yjwu1962@gmail.com   
Division of Allergy, Immunology and Rheumatology, Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Yi-Hsing Chen       dr.yihsing@gmail.com   
Thailand
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University Hospital Recruiting
Chiang Mai, Muang District, Thailand, 50200
Contact: Worawit Louthrenoo       wlouthre@gmail.com   
United Arab Emirates
Department of Rheumatology, Dubai Hospital Recruiting
Dubai, United Arab Emirates
Contact: Jamal Al-Saleh       jaalsaleh@dha.gov.ae   
Contact: Munther Khamashta       munther.khamashta@kcl.ac.uk   
Sponsors and Collaborators
Monash University
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
University of Malaya
University of Santo Tomas Hospital, Philippines
National University Hospital, Singapore
Tan Tock Seng Hospital
Chang Gung Memorial Hospital
Taichung Veterans General Hospital
Chiang Mai University Hospital, THAILAND
Dubai Hospital, Dubai, UNITED ARAB EMIRATES
Middlemore Hospital, New Zealand
North Shore Hospital, Auckland, NEW ZEALAND
Auckland District Health Board, Auckland, NEW ZEALAND
Teaching Hospital Kandy, SRI LANKA
Sir Ganga Ram Hospital, New Delhi, INDIA
University of the Philippines, Philippines
Investigators
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Study Chair: Eric Morand Monash University

Additional Information:
Publications:
Golder V., Kandane-Rathnayake R., Huq M., Nim H.T., Louthrenoo W., Luo S.F., Jan Wu Y.J., Lateef A., Sockalingam S., Navarra S.T. V., Zamora L., Hamijoyo L., Katsumata Y., Harigai M., Chan M., O'Neill S., Goldblatt F., Lau, C.S., Li Z.G., Hoi A, Nikpour M., Morand E., 6 Sep 2019, Lupus low disease activity state as a treatment endpoint for systemic lupus erythematosus: a prospective validation study. The Lancet Rheumatology. Vol.1 Issue 2.
Golder V., Kandane-Rathnayake R., Huq M., Louthrenoo W., Luo S.F., Jan Wu Y.J., Lateef A., Sockalingam S., Navarra S.T. V., Zamora L., Hamijoyo L., Katsumata Y., Harigai M., Chan M., O'Neill S., Goldblatt F., Lau, C.S., Li Z.G., Hoi A, Nikpour M., Morand E. Evaluation of remission definitions for systemic lupus erythematosus: a prospective cohort study. The Lancet Rheumatology. Oct 2019, Vol.1 Issue 2.

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Responsible Party: Eric F Morand, Professor of Medicine; Head, School of Clinical Sciences at Monash Health, Monash University;DIrector, Rheumatology, Monash Health, Monash University
ClinicalTrials.gov Identifier: NCT03138941    
Other Study ID Numbers: APLC LLDAS Study
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases