Unique ID issued by UMIN | UMIN000042298 |
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Receipt number | R000048284 |
Scientific Title | Elucidation of refractoriness in treating systemic lupus erythematosus |
Date of disclosure of the study information | 2020/10/31 |
Last modified on | 2023/05/11 17:50:47 |
A clinical research to find out the cause of difficulties in treating systemic lupus erythematosus
Research for difficulties in SLE treatment
Elucidation of refractoriness in treating systemic lupus erythematosus
Research for refractory SLE
Japan |
Systemic Lupus Erythematosus
Clinical immunology |
Others
NO
To find out biomarkers for refractoriness in treating SLE
Others
Biomarker exploration
Exploratory
Pragmatic
Not applicable
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.
Observational
15 | years-old | <= |
Not applicable |
Male and Female
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 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).
40
1st name | Hajime |
Middle name | |
Last name | Yoshifuji |
Kyoto University Graduate School of Medicine
Clinical Immunology & Rheumatology
6068507
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
0757513111
yossii@kuhp.kyoto-u.ac.jp
1st name | Hajime |
Middle name | |
Last name | Yoshifuji |
Kyoto University Graduate School of Medicine
Clinical Immunology & Rheumatology
6068507
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
075-751-3111
yossii@kuhp.kyoto-u.ac.jp
Kyoto University
GSK
Profit organization
United States of America
Kobe City Medical Center General Hospital
Support Ctr. Kyoto University Hospital
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
075-751-4748
ctsodan@kuhp.kyoto-u.ac.jp
NO
2020 | Year | 10 | Month | 31 | Day |
none
Unpublished
Preinitiation
2020 | Year | 10 | Month | 26 | Day |
2020 | Year | 09 | Month | 14 | Day |
2020 | Year | 10 | Month | 30 | Day |
2022 | Year | 07 | Month | 31 | Day |
2023 | Year | 01 | Month | 31 | Day |
2023 | Year | 07 | Month | 31 | Day |
2024 | Year | 01 | Month | 31 | Day |
none
2020 | Year | 10 | Month | 30 | Day |
2023 | Year | 05 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048284
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