Korean multicenter registry of systemic lupus erythematosus
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0001253
- Lead Sponsor
- Chonnam National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 600
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.
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.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prognosis, cor-morbidity and treatment efficacy of SLE
- Secondary Outcome Measures
Name Time Method prevalence and prognosis of lupus nephritis