Systemic Lupus Erythematosus
Conditions
Interventions
None listed
Sponsors
Kyoto University
Kobe City Medical Center General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient Selection Criteria for Standard Treatment Refractoriness: Patients receiving induction steroid treatment (prednisolone (PSL) 0.5-1 mg/kg/day) (criterion 1-1). Patients who relapsed while in a stable-phase taking PSL 10mg/day or more who had been received relatively high-dose steroid treatment as a remission induction (PSL 0.5-1 mg/kg/day) (Criterion 1-2). 2. Criteria for patients with specific drug treatment resistance: Patients whose doctor has decided to administer belimumab as treatment for SLE. Patients with mild to moderate SLE who have difficulty decreasing steroid dose even with steroid therapy combined with at least one type of immunosuppressive therapy. 3. Criteria for selecting difficult cases of steroid dose reduction due to fatigue: Patients with normal serum complement, anti-DNA antibodies, CRP and taking less than 10 mg/day of PSL, yet described as "significant" or "severe" fatigue using the quality of life assessment tool (SSC), and patients with a feeling of "none" fatigue. 4. Healthy person Use existing samples of healthy (anonymized (no correspondence table)) RNA collected in "G1006-5: Research on autoimmune disease-related genetic factors". Randomly select the target population so that there is no significant divergence in age and gender, but if the divergence is large, obtain new consent and collect blood samples.
Exclusion criteria
Exclusion criteria: Exclusion criteria common among studies corresponding to selection criteria 1-4 are patient's refusal to the consent and patients under 15 years of age. In addition, the following exclusion criteria is established. 1. Standard treatment refractory patient exclusion criteria: When the attending physician deems it inappropriate due to complications (eg, malignant tumor, renal disorder with eGFR <15, severe lung disorder, central nervous system disorder). 2. Exclusion criteria for patient's refractory to specific drug treatment: Excludes patients with central nervous system disorders and highly active nephritis. When the attending physician considers it inappropriate due to other complications (for example, malignant tumor, serious lung disorder). 3. Exclusion criteria for cases of difficulty in reducing steroid dose due to fatigue: When the attending physician deems it inappropriate due to taking medication for the patient, because of complications (eg, malignant tumor, renal disorder with eGFR <15, severe lung disorder, central nervous system disorder, hypothyroidism) and neuropsychiatric symptoms that can cause fatigue 4. Exclusion criteria for healthy subjects: When the attending physician deems it inappropriate due to complications (for example, complications of malignant tumors, autoimmune diseases, eGFR <15, serious lung disorders, central nervous system disorders).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We did not set primary or secondary outcomes since this study is an exploratory research. We mainly search for cytokines or genes that are related to the refractoriness. | — |
Countries
Japan
Contacts
Public ContactHajime Yoshifuji
Kyoto University Graduate School of Medicine Clinical Immunology & Rheumatology
Outcome results
None listed