Skip to content

Korean multicenter registry of systemic lupus erythematosus

Korean multicenter registry of systemic lupus erythematosus

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0001253
Enrollment
600
Registered
2014-10-14
Start date
2014-09-16
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Chonnam National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: We enroll all patients fulfilled four or more of the American College of Rheumatology (ACR) 1997 revised classification criteria for SLE. * The revised criteria for the diagnosis of systemic lupus erythematosus 1. Malar rash: Fixed erythema, flat or raised, over the malar eminences, tending to spare the nasolabial folds 2. Discoid rash: Erythematous raised patches with adherent keratotic scaling and follicular plugging; atrophic scarring may occur in older lesions 3. Photosensitivity: Skin rash as a result of unusual reaction to sunlight, by patient history or physician observation 4. Oral ulcers: Oral or nasopharyngeal ulceration, usually painless, observed by physician 5. Arthritis: Nonerosive arthritis involving 2 or more peripheral joints, characterized by tenderness, swelling, or effusion 6. Serositis a) Pleuritis: convincing history of pleuritic pain or rubbing heard by a physician or evidence of pleural effusion OR b) Pericarditis: documented by ECG or rub or evidence of pericardial effusion 7. Renal disorder a) Persistent proteinuria > 500 mg per day or > 3 + if quantitation not performed OR b) Cellular casts: may be red cell, haemoglobin, granular, tubular, or mixed 8. Neurologic disorder a) Seizures: in the absence of offending drugs or known meta-bolic derangements; e.g., uremia, ketoacidosis, or electrolyte imbalance OR b) Psychosis: in the absence of offending drugs or known metabolic derangements, e.g., uremia, ketoacidosis, or electrolyte imbalance 9. Hematologic disorder a) Hemolytic anemia-with reticulocytosis OR b) Leukopenia: < 4,000/mm3 total OR c) Lymphopenia: < 1,500/mm3 on two or more occasions OR d) Thrombocytopenia: < 100,000/mm3 in the absence of offending drugs 10. Immunologic disorder a) Anti-DNA: antibody to native DNA in abnormal titre OR b) Anti- Sm: presence of antibody to Sm nuclear antigen OR c) Positive finding of antiphospholipid antibodies based on (1) an abnormal serum level of lgG or lgM anticardiolipin antibodies, (2) a positive test result for lupus anticoagulant using a standard method, or (3) a false-positive serologic test for syphilis known to be positive for at least 6 months and confirmed by Treponema pallidum immobilization or fluorescent treponemal antibody absorption test 11. ANA: Abnormal titer of ANA by immunofluorescence or equivalent assay at any point in time, in the absence of drugs known to be associated with drug-induced lupus syndrome This classification is based on 11 criteria. For the purpose of identifying patients in clinical studies, a person must have SLE if any 4 or more of the 11 criteria are present, serially or simultaneously, during any lnterval of observation.

Exclusion criteria

Exclusion criteria: Patients were excluded if they had incomplete data or advanced co-morbidity, such as diabetus or primary kidney disease that could affect complicate assessment of lupus activity.

Design outcomes

Primary

MeasureTime frame
Prognosis, cor-morbidity and treatment efficacy of SLE

Secondary

MeasureTime frame
prevalence and prognosis of lupus nephritis

Countries

Korea, Republic of

Contacts

Public ContactDong-Jin Park

Chonnam National University Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026