Validation of the Lupus Low Disease Activity State in the Asia Pacific Region
Official title: Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region
Run by Monash University · NCT03138941 · Data updated 2026-11-12
This study is testing if keeping lupus patients in a low disease activity state can help them avoid serious health problems over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | Monash University Academic / other |
| Locations | 20 sites (Adelaide, South Australia and 19 other locations) |
| Status | Recruiting |
| Started | September 1, 2013 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2032 |
| Registry record updated | December 12, 2024 |
| Trial ID | NCT03138941 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old who meet the classification criteria for systemic lupus erythematosus.
✕Probably not a fit
Patients under 18 years of age or those unable to provide consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the association between achieving the Lupus Low Disease Activity State (LLDAS) and improved outcomes in patients with Systemic Lupus Erythematosus (SLE). It is an international, multi-centre observational study that will follow patients for approximately five years, collecting data on disease activity, treatment, and quality of life. The study aims to determine if sustained attainment of LLDAS can protect against organ damage accrual in SLE patients.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with systemic lupus erythematosus, potentially enhancing their quality of life and reducing organ damage.
How similar studies have gone: Other studies have shown promising results in assessing disease activity states in lupus, suggesting that this approach may yield valuable insights.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Rheumatology Unit, Royal Adelaide Hospital
Adelaide, South Australia, Australia Recruiting -
Department of Rheumatology, Flinders Medical Centre
Adelaide, South Australia, Australia Recruiting -
School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing & Health Sciences
Clayton, Victoria, Australia Recruiting -
Department of Rheumatology, St Vincent's Hospital (Melbourne)
Fitzroy, Victoria, Australia Recruiting -
Department of Rheumatology and Immunology, People's Hospital Peking University Health Science Center
Beijing, Western District, China Recruiting -
Rheumatology and Immunology department, Peking University First Hospital
Beijing, Xicheng District, China Recruiting
Show 14 more locations
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Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Padjadjaran University/ Hasan Sadikin General Hospital
Bandung, West Java, Indonesia Recruiting -
The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health
Kitakyushu, Japan Recruiting -
Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University
Tokyo, Japan Recruiting -
Institute of Rheumatology, Tokyo Women's Medical University
Tokyo, Japan Recruiting -
Joint and Bone Center, University of Santo Tomas Hospital
Manila, Philippines Recruiting -
University of the Philippines
Quezon City, Philippines Recruiting -
Rheumatology Division, University Medical Cluster, National University Hospital
Singapore, Singapore Recruiting -
Department of Rheumatology, Allergy & Immunology, Tan Tock Seng Hospital
Tan Tock Seng, Singapore Recruiting -
Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases
Seoul, South Korea Recruiting -
Division of Nephrology, Teaching Hospital Kandy, Sri Lanka
Kandy, Sri Lanka Recruiting -
Department of Rheumatology, Allergy and Immunology Chang Gung Memorial Hospital Chang Gung University
Guishan, Taoyuan County, Taiwan Recruiting -
Division of Allergy, Immunology and Rheumatology, Taichung Veterans General Hospital
Taichung, Taiwan Recruiting -
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University Hospital
Chiang Mai, Muang District, Thailand Recruiting -
Division of Rheumatology & Clinical Immunology, Department of Medicine, Queen Mary Hospital, the University of Hong Kong
Pok Fu Lam, Hong Kong Active not recruiting
Study contacts
- Study coordinator: Eric F Morand
- Email: eric.morand@monash.edu
- Phone: + 61 3 8572 2650
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Effects of anifrolumab on arterial inflammation in SLE patients
This study tests whether anifrolumab can reduce blood vessel inflammation in people with active systemic lupus erythematosus.
-
Home urine testing for people with lupus
Participants with lupus will try weekly home urine tests in addition to usual care to see if this helps monitor kidney health over a year.
-
CR-402 treatment for refractory autoimmune disease
This study tests CRT-402, a CD19-targeted CAR-T therapy, in adults with active, treatment-resistant autoimmune diseases like SLE, systemic sclerosis, and inflammatory myopathy to see if it is safe and capable of helping control disease.
-
ATG-201 in adults with autoimmune diseases
This early, open-label study tests ATG-201 in adults with autoimmune diseases to see if it is safe and tolerable, and to get initial clues about how the body handles the drug and its effects.
-
Biomarker tests in adults with lupus to see how kidney disease changes over time
Researchers will follow adults with lupus to see if blood and urine biomarkers can predict kidney involvement, flares, and treatment responses during routine care.
-
Sirolimus added to standard therapy for adults with SLE-associated immune thrombocytopenia
This trial tests whether adding sirolimus to usual treatment helps adults with SLE-related immune thrombocytopenia see their platelet counts improve.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.