Validation of the Lupus Low Disease Activity State in the Asia Pacific Region
Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region
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 |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Monash University Academic / other |
| Locations | 20 sites (Adelaide, South Australia and 19 other locations) |
| Trial ID | NCT03138941 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who meet the classification criteria for systemic lupus erythematosus.
Not a fit: Patients under 18 years of age or those unable to provide consent will not benefit from this study.
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 performed: Other studies have shown promising results in assessing disease activity states in lupus, suggesting that this approach may yield valuable insights.
Eligibility criteria
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 this trial is running
Adelaide, South Australia and 19 other locations
- 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)
- Division of Rheumatology & Clinical Immunology, Department of Medicine, Queen Mary Hospital, the University of Hong Kong — Pok Fu Lam, Hong Kong (Active_not_recruiting)
- 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)
Study contacts
- Study coordinator: Eric F Morand
- Email: eric.morand@monash.edu
- Phone: + 61 3 8572 2650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.